The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
mHealth Israel_EU MedTech and eHealth Regulatory FrameworkLevi Shapiro
Presentation by Hogan Lovells, EU MedTech and eHealth Regulatory Framework. Best practices and key changes in the European medtech regulatory environment, 2018.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
mHealth Israel_EU MedTech and eHealth Regulatory FrameworkLevi Shapiro
Presentation by Hogan Lovells, EU MedTech and eHealth Regulatory Framework. Best practices and key changes in the European medtech regulatory environment, 2018.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
This presentation describes regulatory hurdles to keep in mind when acquiring / selling medical devices companies with CE certificates to prevent them from becoming invalid.
Presentation at the Advamed MedTech conference in Boston on 25 September regarding the state of implementation of the EU Medical Devices Regulation MDR, and what companies can still do before its date of application on 26 May 2020
Managing New Requirement for Economic Operator RegimeErik Vollebregt
Presentation of new economic operator regime under the new EU Medical Devices and IVDs Regulations, delivered at the Q1 Medical Devices Regulation conference on 16 July 2019
Q1 Medical Devices Regulation - practical consequences for manufacturersErik Vollebregt
Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry
Presentation at the MedTech Summit 2018 in Brussels concerning the new EU regulatory regime for economic operators in the supply chain of medical devices and IVDs
Use of left over samples under the IVDR and GDPRErik Vollebregt
Presentation on the RAPS Convergence 2017 about the use of left over samples in performance evaluation under the In Vitro Diagnostics Regulation (IVDR) and under the General Data Protection Regulation (GDPR)
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
3. Process MDR
As per end 2015 remaining “political” items
for MDR include:
• CMR substances
• Mandatory liability insurance for
manufacturer and authorised
representative
• Mechanisms for surveillance and
appointment of the Notified Bodies
• Scrutiny mechanism for certain high risk
devices;
• Reprocessing of single use devices
• Tasks of the proposed Medical Device
Coordination Group;
• Clinical investigations
• Transitional periods
• Classification rules
3
4. Process IVDR
As per end 2015 remaining “political” items
for IVDR include:
• Genetic testing
• Mandatory liability insurance for
manufacturer and authorised
representative
• Mechanisms for surveillance and
appointment of the Notified Bodies
• Scrutiny mechanism for certain high risk
devices;
• Clinical performance studies with IVDs;
• Post-Market Surveillance;
• Tasks of the proposed Medical Device
Coordination Group;
• Role of expert panels and reference
laboratories.
5. The last news from the Presidency
• 2 trilogue meetings have taken place
• Willingness between the three parties to agree before 1 July 2016
• This means MDR and IVDR regulations finished and adopted by end
2016
• Transitional regime likely three years
6. We have a final text, and then?
• Many instances of
delegated and
implementing acts are
necessary to make the
MDR and IVDR operational,
many of which impact
companies directly
• Unclear when these acts
will be available;
Commission is not obliged
to take them
• Industry is supposed to be
consulted on acts in
preparation (in practice
MedTech Europe / COCIR
will be consulted)
e.g.:
• regulatory status of (groups of)
products
• Essential Requirements
• Common Specifications
• Summary of Safety and
Performance format
• UDI, EUDAMED
• Notified body requirements and
assessment procedures
• Clinical performance evaluation
requirements
• EU measures against
unsafe/non-compliant devices
• Designation and functioning of
EU reference labs
6
7. Key MDR changes
Item Impact
Clinical Evidence More pre- and post-market data,
PMS plans,
frequently updated CERs
Limited Equivalence Discontinuation or fresh clinical
data
Class Ill and Implants with a long
history of safe use
Invest in pre- and post-market
clinical
Discontinue or invest
Post-Market Monitoring More PMCF, PSURS, annual CERs
New vigilance and annual reporting
More transparency, user and
patient access
Scrutiny Unpredictable launch, delay,
conflicting reviews
8. Key MDR changes (2)
Item Impact
Technical assessment of class lib
implants according to the class Ill
requirements
Additional costs and de-facto up-
classification of
class lib implants to class Ill
Reprocessing Regulation Increased or decreased industry
involvement and level of patient
safety pending outcome
Technical files to be constantly up
to date and readily searchable
New content plus IT system with
real time data from various systems
incl. suppliers
Economic operators regulated Integrate in manufacturers QS or
duplication of compliance activities
9. Key MDR changes (3)
Item Impact
Eudamed / UDI IT solutions, pre- I post-market
data,
(re-) registration fees, labeling,
national vs. EU database?
Up-classification of spine products
and reusable class I
Clinical investigations, design
controls, more audits
Transitional Period Prioritize re-launch, MDD I MDR
decision, capacity, talent,
operational readiness of NB’s
Restricted Substances Product- Component Assessment
Tracking systems I product design
Administrative Burden Each and every label to be updated
Implant cards for all implants, UDI-
DoC link
10. IVDR key changes
• Operational impact on
generic large multinational
IVD company
12. Definitions MDR
Subject Before entry into force During After
Chapter I
Definitions
Check if cosmetic implant or other product is on Annex XV list Look out for Common Specifications for Annex
XV devices and implement them
Check if devices fall in enlarged scope of “accessory” Obtain CE mark for accessory under new
regime
Obtain CE mark for accessory under
new regime
Check if custom device is still custom device under new definition Obtain CE mark if changed to regular medical
device
Products specifically intended for the cleaning, disinfection or
sterilisation of medical devices and devices for the purpose of
control or support of conception will be considered medical
devices. Make gap assessment for information required for CE
marking of devices concerned.
Develop and implement transition strategy for
devices concerned into CE marking, generate
information needed for CE marking.
Obtain CE mark for devices
concerned under new regime.
Standalone software is no longer classified as active medical
device: revisit classification of software currently on the market as
medical device and make gap assessment for additional technical
file requirements for software classified in higher risk class.
Amend technical files for software in
accordance with requirements for higher risk
class, have software CE marked by notified
body if class IIa or higher.
Apply classification rules for new
software
ANNEX XV
LIST OF GROUPS OF
PRODUCTS WITHOUT
AN INTENDED
MEDICAL PURPOSE
· Identify Annex XV candidate devices in company’s portfolio
· Watch for Common Specifications becoming available for devices concerned
· Start building up technical documentation and if necessary QMS
· CE mark Annex XV devices using
Common Specifications
13. Each IVD currently on the market
must be transitioned in new
system
• Check if instrument or product is still or becomes (part of) an IVD
• under amended definition of IVD
• under amended definition of accessory
• under new definition of companion diagnostic
• under new definition of kit
14. Definitions IVDR
Subject Before entry into force During After
Chapter I Definitions Article 2 (2) contains a new definition:
'in vitro diagnostic medical device’ means any medical device which
is a reagent, reagent product, calibrator, control material, kit,
instrument, apparatus, equipment, software or system, whether used
alone or in combination, intended by the manufacturer to be used in
vitro for the examination of specimens, including blood and tissue
donations, derived from the human body, solely or principally for the
purpose of providing information:
– concerning a physiological or pathological process or state;
– concerning a congenital abnormality;
– concerning the predisposition to a medical condition or a disease;
– to determine the safety and compatibility with potential recipients;
– to predict treatment response or reactions;
– to define or monitor therapeutic measures.
Categorize existing devices and determine if they are in or out of
scope of IVDR
Decide whether to CE mark new IVDs under IVDD,
IVDR or neither depending on whether they are in
scope for directive and/or regulation.
CE mark new IVDs under IVDR if in scope
The IVDR Regulation shall not apply to (article 1 (2):
(a) products for general laboratory use or research-use only
products, unless such products, in view of their characteristics, are
specifically intended by their manufacturer to be used for in vitro
diagnostic examination;
(b) invasive sampling devices or those which are directly applied to
the human body for the purpose of obtaining a specimen;
(c) higher metrological order internationally certified reference
materials.;
(d) materials used for external quality assessment schemes;
Categorize existing devices and determine if they are in or out of
scope of IVDR
Decide whether to CE mark new IVDs under IVDD,
IVDR or neither depending on whether they are in
scope for directive and/or regulation.
CE mark new IVDs under IVDR if in scope
Check if devices fall in enlarged scope of “accessory” Obtain CE mark for accessory under new regime Obtain CE mark for accessory under new
regime
Check if custom device is still custom device under new definition Obtain CE mark if changed to regular medical device
Categorize existing IVDs to check if in scope of ‘device for near
patient testing’ or ‘device for self-testing’ or ‘companion diagnostic’ to
determine future conformity assessment procedure
Check if IVD constitutes a ‘device for near patient
testing’ or ‘device for self-testing’ or ‘companion
diagnostic’, to which a specific conformity
assessment procedure applies.
Check if IVD constitutes a ‘device for near
patient testing’ or ‘device for self-testing’ or
‘companion diagnostic’, to which a specific
conformity assessment procedure applies.
Categorize existing IVDs to check if in scope of definition of ‘single
use device’ or ‘kit’ to determine impact on labelling and UDI
requirements
Check if IVD is in scope of definition of ‘single use
device’ or ‘kit’ to determine impact on labelling and
UDI requirements
Check if IVD is in scope of definition of
‘single use device’ or ‘kit’ to determine
impact on labelling and UDI requirements
Assess parallel trade procedure in article 14 and draft
procedure/policy for dealing with parallel trader requests to sign off
on amended labelling and/or packaging (article 14).
Apply procedure/policy for parallel trade label and/or
packaging signoff requests
Apply procedure/policy for parallel trade
label and/or packaging signoff requests
15. Chapter II – Making available of
devices, obligations of economic
operators, reprocessing, CE
marking, free movement
16. Supply chain controls
Manufacture
r
Importer Distributor
End
User
Post market surveillance and vigilance
Regulatory compliance of device
Verify compliance Verify compliance
Supplier
Unannounced NB
inspections
17. Making available & obligations
MDRChapter II Making
available of devices,
obligations of economic
operators, reprocessing,
CE marking, free
movement
Assess potential effect of reprocessing and
home brews under new hospital produced (so
called ‘home brew’) devices rules on company
business model
Monitor compliance of hospitals with
reprocessing and home brews under new
hospital produced devices rules
Monitor compliance of hospitals
with reprocessing and home brews
under new hospital produced brew
devices rules (task of national
authorities)
Manufacturers must establish, execute,
maintain and document a system for risk
management as described in Section 1a in
Annex I
Manufacturers must conduct a clinical
evaluation in accordance with the
requirements set out in Article 49 and
Annex XIII, including post-market clinical
follow-up.
Assess medical devices provided as service via
internet (article 5)
CE mark device as service under new
regime
Assess Own Brand Labelling consequences of
the requirements that a full technical file must be
present at each manufacturer (Article 8(4)).
Change business and certification setup
into virtual contract manufacturing, or get all
required contracts to access key
documentation from OEM in place.
Review new manufacturer responsibilities and
make gap assessment against QMS
Amend and implement amended QMS;
apply QMS optionally to devices placed on
the market in transitional period
Apply amended QMS
Make gap assessment against new recall
requirements (article 8 (8); amend procedures
and distribution agreements – adopt new [8a.
Manufacturers shall have a system for reporting
of incidents and field safety corrective actions as
described in Article 61.
Make gap assessment against new QMS criteria
in article 8 (5); amend procedures
Implement amended QMS; consider
revising directly into new ISO 13485:201x at
the same time
Art. 8 (13) mandatory insurance for product
liability: monitor developments
Purchase and maintain relevant insurance Maintain relevant insurance
New authorised representative (AR)
requirements article 9-10 – amend AR
agreement and procedures – expect AR
renegotiations or AR to cease activities if liability
requirements are adopted
Ensure continued access to AR services
when relevant
18. Making available & obligations
MDR
Review autonomous general obligations
of importers and distributors (articles 11-
12, e.g. verify compliance of the device,
inform competent authority of non-
compliance of the device and implement
corrective action) and amend contracts
accordingly
Implement SOPs, amend agreements in supply
chain
Select and mandate candidate for
person responsible for regulatory
compliance (art. 13)
Make and keep available in the organisation a
person responsible for regulatory compliance;
ensure training and where appropriate take out
personal liability insurance
Keep available in the organisation a
person responsible for regulatory
compliance
Prepare for new relabelling / repackaging
regime (art. 14),– draft SOP for new
regime
Implement and apply SOP Apply SOP
New regime for reprocessing (art 15) –
design traceability that can show if an
incoming complaint is about a new or
reprocessed single use device.
· Determine what Member States will allow
reprocessing
· Implement traceability that can show if an
incoming complaint is about a new or
reprocessed single use device.
· Ensure any reprocessing is resulting in
patient safety to stay on level of first time
use
Ensure any reprocessing is resulting
in patient safety to stay on level of first
time use
Continue to monitor changed
allowance per country
Implant card (art 16 + implementing acts) Define system of implant cards, or alternative
allowed systems
Declaration of conformity model (art 17
annex III) – check for gaps against
current model used
Amend existing DoC’s upon transfer per
product (group) into the new requirements
aligned with transfer plan agreed with notified
body.
Use MDR provided model of DoC
Parts manufacturers to ensure that the
part does not adversely affect the safety
and performance of the device. (art 21)
Parts manufacturers must generate supporting
evidence for this. Supporting evidence shall be
kept available to the competent authorities of
the Member States.
Parts manufacturers to generate
supporting evidence for each new part
placed on the market and to be kept
available to the competent authorities
of the Member States.
21. Chapter III – Identification and
traceability of devices, registration
of devices and of economic
operators, summary of safety and
clinical performance, European
databank on medical devices
22. The Eudamed “cathedral”
• Will Eudamed realistically be
ready to support
• all these functions
• in time?
“Who knows where the road
may lead us, only the fool
would say
Who knows if we'll meet along
the way
Follow the brightest star as far
as the brave may dare
What will we find when we get
there”
[Alan Parsons Project – La
Sagrada Familia]
OR
24. MDR/IVDR and Eudamed
• Eudamed will contain integrated electronic systems on
• European UDI
• Registration of devices and economic operators
• Scrutiny applications (possibly other conformity assessments)
• Certificates issued by notified bodies
• Clinical investigations
• Vigilance
• Market surveillance activities
• Registration of subsidiaries and subcontractors of notified bodies
• A large part of the information in Eudamed will become publicly available
in accordance with the provisions regarding each part of the electronic
system
• Will “do away with diverging national registration requirements which
have emerged over recent years and which have significantly increased
compliance costs for economic operators. It will therefore also contribute
to reducing the administrative burden on manufacturers.”
25. Traceability, registration, Eudamed
MDR and IVDR
Chapter III
Identification and
traceability of devices,
registration of devices
and of economic
operators, summary of
safety and clinical
performance,
European databank on
medical devices
UDI (art 23 (1) MDR / 21 (1) IVDR) Distributors and
importers shall co-operate with the manufacturer or
authorized representative to achieve an appropriate level
of traceability of devices. – implement changes to
distribution agreements
implement changes to distribution agreements
and SOPs
Article 23 (2) MDR / 21 (2) IVDR: For devices, other than
custom-made or investigational devices, economic
operators shall be able to identify the following to the
competent authority, for the period referred to in Article
8(4):
(a) any economic operator to whom they have supplied a
device;
(b) any economic operator who has supplied them with a
device;
(c) any health institution or healthcare professional to
whom they have supplied a device. – implement and
improve traceability
Get traceability systems in place in supply
chain, where possible based on UDI
Article 24 (3) MDR / 22 (3) IVDR assign UDI to device
and higher levels of packaging and (24 (4)) place that on
the label and higher levels of packaging and (24a-c + (5))
keep UDI administration for reporting and tech file.
Choose type of UDI system to be applied, in
line with global requirements towards UDI
If possible, manufacturers may (Article 24b
MDR / 22b IVDR) apply new process for
registration of devices prior to placing on the
market
Apply new process for registration of
devices prior to placing on the market
(Article 24b MDR / 22 b IVDR)
When implemented, companies may apply
process for registration of manufacturers, and
authorised representatives and importers, to
obtain a single registration number to identify
them for the purposes of UDI and traceability.
Apply process for registration of
manufacturers, authorised
representatives and importers, single
registration number (Article 25a)
Identify information that must be reflected in summary of
safety and performance for each device and conceive
plan for generating summaries for each class III and
implantable device (article 26).
Execute plan for producing summaries for each
device. Make available summaries for
implantable and class III certified under MDR
(Article 26 MDR / 25 IVDR)
Draw up and make available summary
of safety and clinical performance for
class III and implantable devices,
other than custom-made or
investigational devices (Article 26
MDR / 25 IVDR)
If available: Article 27 MDR / 25 IVDR – enter
data into EUDAMED
Article 27 / 25 IVDR – enter data into
EUDAMED
28. Notified bodies
• Stronger supervision on Notified Bodies
• Continuation of joint assessment; handbook transcribed into NB annex in
MDR
• Scrutiny on high risk devices
• Thorough testing and regular checks on manufacturers
• Unannounced factory inspections
• Rotation of notified body staff involved in assessment
• Adoption of common technical specifications
• Notified Body numbers continue to drop
• Resources will become critical in transition
29. Most important for manufacturer
• Article 29-31: Requirements relating to Notified Bodies
• All Notified Bodies must be re-designated
• Joint Assessment
• Article 42: Conformity Assessment Procedure
• Unannounced Audits and testing of samples
• Article 44: Mechanism for scrutiny of certain conformity assessments
• For class III products and implants
• Peer-review of an expert panel on an European level
• Article 60: Post-market surveillance system of the manufacturer
• Periodic post-market surveillance reports for class III products and
implants
• Reviewed by Notified Body and make available to Competent
Authorities
30. Most important for manufacturer
• Annex IIa: Technical Documentation on post-market surveillance
• Establish post-market surveillance plan
• Periodic safety update report reviewed by Notified Body and
available to CA
• Annex VI Requirements to be met by Notified Body
• Pay particular attention to clinical data from post-market surveillance
and PMCF activities undertaken since the previous (re-)certification
• Annex VIII Conformity Assessment
• The Notified Body shall randomly perform unannounced on-site
audits
• The Notified Body shall employ device reviewers with sufficient
clinical expertise, including the use of external clinical expertise
• Procedure on scrutiny for class III products and implants
• Annex XIII Clinical Evaluation and Post-Market Clinical Follow-up
• Annex XV List of Groups of Products without an intended medical
purpose
• e.g. dermal fillers, fat removing devices or lasers for hair removal
32. Chapter V – Classification and
conformity assessment
33. MDR: conformity assessment
issues
• Re-/up classification of devices (e.g. substance based, implants)
• Resources?
• Scrutiny procedure (an expert panel should assess several hundred
devices per year within 60 days)
• PSURS and trend reporting
• Special conformity assessments procedures for substance based
MD
• Reporting and planning obligations of member states to Commission
• Problematic
• Liability and insurance for manufacturers and Authorized
Representatives
35. IVDR: quantum leap
• IVDs did not feature prominently in political discussion around new
medical devices regulations, but immense changes in the works
• IVDs for ‘indirect medical purpose’ (“life style tests”) likely to be
regulated
• Genetic testing requirements
• Radical changes in conformity assessment / market access
36. Classification
Currently the ‘doesn’t fit in
a specific rule’ class is
self-certified, under IVDR
notified body certified
Only remaining self
certification
46. Chapter VI – Clinical evaluation
and clinical investigations
47. Clinical requirements
• MDR proposal is about “More Data, Really”
• Chapter VI: Clinical evaluation and clinical investigations: article 49 –
60
• Annex XIII (Part A): CLINICAL EVALUATION
• Annex XIII (Part B): POST-MARKET CLINICAL FOLLOW-UP
• Annex XIV: CLINICAL INVESTIGATIONS
• Relation to current and future ISO 14155 standard problematic
• MDR will likely not be in line with global state of art in medical
devices GCP
48. Clinical requirements – MDR
chapter VI
• Article 49: Clinical evaluation
• Article 50: General requirements regarding clinical investigations
• Article 51: Application for clinical investigations
• Article 52: Registration of clinical investigations
• Article 53: Electronic system on clinical investigations
• Article 54: Clinical investigations with devices authorised to bear the CE
marking
• Article 55: Substantial modifications to a clinical investigation
• Article 56: Information exchange between Member States
• Article 57: Information by the sponsor in the event of temporary halt or
termination of a clinical investigation
• Article 58: Clinical investigations conducted in more than one Member
State
• Article 59: Recording and reporting of events occurring during clinical
investigations
• Article 60: Implementing acts
49. Clinical requirements
• MDR will
• elaborate on the current clinical investigation requirements in
Article 15 MDD and Annex X, and align the MDR with the clinical
trials regime for medicinal products
• propose system for clinical investigations similar to the current
system for medicinal products including notification in a
centralized database
• member state authority assessment of clinical investigations – the
EP proposes to have this done by ethics committees.
• make Post-Market Clinical Follow-up (PMCF) mandatory as part
of the clinical evaluation cycle for the device concerned,
essentially implementing the PMCF MEDDEV (MEDDEV 2.12/2
rev. 2)
• There will be more attention for clinical benefit and efficacy
(defined in article 2 (37d) and (37e)) and effectiveness (article 2
(37f)
50. Clinical requirements
• Important concepts have been introduced that are inconsistent with the
current Good Clinical Practice standard for medical devices, the MDD
harmonized EN ISO 14155:2011 (e.g. proposed definition of ‘sponsor’
under the MDR is far wider than under EN ISO 14155:2011)
• Not clear at this moment if and how the EU legislation will reconcile the
proposal with the GCP standard
• At this point it is safe to say that requirements for clinical evidence will
increase substantially and will require significantly higher investment
from companies.
• In order to design, work with and interpret clinical studies companies will
need to invest in staff who are knowledgeable in
• Regulatory affairs,
• Good Clinical Practice (GCP) and
• Clinical investigation
• Meet the requirement of having a person responsible for regulatory
compliance
51. Clinical – clinical evaluation
• Prepare with MEDDEV 2.7/1 rev 4 (underway – not published yet)
• Annual mandatory update for implantables and class III devices!
53. IVDR: performance evaluation and
performance studies
• Performance evaluation mandatory
• A performance evaluation shall follow a defined and methodologically
sound procedure for the demonstration of the following, in accordance
with the principles set out in this Article and with Annex XII:
(a) scientific validity;
(b) analytical performance;
(c) clinical performance.
The data and conclusions drawn from the assessment of these
elements shall constitute the clinical evidence for the device. The
clinical evidence shall scientifically demonstrate that the intended
clinical benefit(s) and safety will be achieved according to the state of
the art in medicine.
• post-market performance follow-up plan mandatory, for class C and D
yealry updates required
54. Performance studies
• More clinical data required for conformity assessment of IVDs
• “As a general rule, clinical evidence should be sourced from clinical
performance studies to be carried out under the responsibility of a
sponsor taking responsibility for the clinical performance study.”
• Regime for interventional performance studies
• where invasive sample taking is done only for the purpose of the
performance study
• where it concerns an interventional clinical performance study
• where the conduct of the study involves additional invasive
procedures or other risks for the subjects of the studies
• in case of performance studies involving companion diagnostics
• Clinical performance studies data not commercially sensitive data
55. Performance studies
• Scientific and ethical approval necessary for performance studies
• Member state agency assesses scientific aspects
• Ethics committee assesses ethical aspects
57. Chapter VII – Post-market
surveillance, vigilance and market
surveillance
58. Post-market surveillance
• Manufacturer must implement post market surveillance system as part of
the post market surveillance plan:
(a) to update the benefit risk determination and risk management, the
design and manufacturing information, the instructions for use and the
labelling;
(b) to update the performance evaluation;
(c) to update the summary of safety and performance;
(d) for the identification of needs for preventive, corrective or field
safety corrective action;
(e) for the identification of possibilities to improve the usability,
performance and safety of the device;
(f) when relevant, to contribute to the post-market surveillance of other
devices;
(g) to detect and report trends
• Manufacturer must make annual PSUR per device or group
59. Vigilance
• Report electronically:
(a) any serious incident involving in respect of devices made available
on the Union market, except expected erroneous results which are
clearly documented and quantified in the product information and in
the technical documentation and are subject to trend reporting
pursuant to Article 59a;
(b) any field safety corrective action in respect of devices made
available on the Union market, including any field safety corrective
action undertaken in a third country in relation to a device which is
also legally made available on the Union market, if the reason for
the field safety corrective action is not limited to the device made
available in the third country.
• Implementation of EU electronic system for vigilance to be used by
Commission and authorities
60. Market surveillance
• Central EU surveillance policy that member states must fit their national
surveillance plans in
• New procedures to cooperate between member states and Commission
in case of IVDs that are public health risk or non-compliance
• Electronic system on market surveillance will be set up
61. Vigilance and market surveillance
• Advantages
• EU-established binding standard procedures
• Disadvantages
• Expected that many member states will not be able to commit the
resources that the implementation of the vigilance and market
surveillance procedures will require for lack of political sense of
urgency
• Preparation
• Companies will need to review their internal vigilance and post-
market surveillance processes to prepare to scale for the increased
reporting requirements
63. Chapter VIII – Cooperation
between member states, Medical
Device Coordination Group, expert
panels and device registers
64. Governance
• Due to the fact that the MDCG will not be able to work like the CMC or
the current CAMD there will be the great risk of un-harmonized
implementation
66. Chapter IX – Confidentiality, data
protection, funding, penalties
67. Confidentiality, data protection,
funding, penalties
Chapter IX Confidentiality, data
protection, funding, penalties
· Prepare for new penalties regime
under MDR
· Prepare for market funded
surveillance
68. Chapter X – Final provisions
(transitional regime etc.)
69. No grandfathering
THERE IS NO GRANDFATHERING IN
THE EU !
• EU will require that all products on
the market are phased into the new
system by the end of transitional
period
• This mean that you have to do a new
conformity assessment under the
new rules for all devices currently on
the market or remove the product
from the market
71. Timeline MDR
Q3/4
2016
Adoption
of MDR
Q1/Q2
2017
Entry into
force
Q1/Q2
2020
End of
transition
period
MDR
Q1/Q2 2022
Last
possible
granted
MDD
certificate
expires
Best current
prediction of
transitional regime
71
Certs
grace
period
Notified Bodies
reaccreditation
under MDR
Transition period of 3
years with Sunshine
74. www.axonlawyers.com
THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
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