The slide are solely prepared by Educo Life Science
Module 1 will cover the following:
Regulatory, guidance and standards for gathering medical device clinical evidence
>How does the regulation apply to gathering of clinical evidence
>What guidance and standard documents need to be followed when gathering clinical evidence
>Clinical evidence for different device classes and the procedures relative to each
>What data, when, why, and how
>Clinical definitions and terminology
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.
Presentation: Medical Devices: how to stay included workshop - Annual ReportsTGA Australia
Session 4: Annual Reports: This presentation discusses the requirements and importance of annual reports including information that is required by the TGA and recognising avoidable errors when writing an annual report.
Devices Sponsor Information Day: 4A - Medical Devices - Audit assessmentsTGA 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
Premarket Clinical Evaluation under the EU MDR proposalAnnet Visscher
Premarket Clinical Evaluation under the current version of the European Medical Device Regulation proposal. What are key elements and how does it impact the clinical evidence needs?
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.
Presentation: Medical Devices: how to stay included workshop - Annual ReportsTGA Australia
Session 4: Annual Reports: This presentation discusses the requirements and importance of annual reports including information that is required by the TGA and recognising avoidable errors when writing an annual report.
Devices Sponsor Information Day: 4A - Medical Devices - Audit assessmentsTGA 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
Premarket Clinical Evaluation under the EU MDR proposalAnnet Visscher
Premarket Clinical Evaluation under the current version of the European Medical Device Regulation proposal. What are key elements and how does it impact the clinical evidence needs?
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
TGA presentation: medical devices audit assessmentsTGA Australia
An overview of the medical devices audit assessment process, including explanation about the difference between Level 1 and Level 2 audits and the information sponsors are generally required to provide.
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
Presentation: Clinical Evidence GuidelinesTGA Australia
This presentation provided an insight into the publication of the clinical evidence guidelines and an overview of clinical evidence requirements for medical devices. It also gave information about the level of clinical evidence required and the reason this level of evidence is required. Finally this presentation covered common errors made with clinical evidence.
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...
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
Devices Sponsor Information Day: Session 3B: Medical devices (IVDs) - applica...TGA Australia
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
Device Sponsor Information Day: Session 2: Clinical evidence - pre-market and...TGA Australia
This presentation provided an insight into the clinical evidence requirements for medical devices. It also gave information about the level of clinical evidence required for conformity assessment procedures and during application audits. Lastly, it outlined requirements to keep contemperaneous clinical evidence once a device is included in the ARTG.
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
Presentation: Recall of Therapeutic GoodsTGA 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.
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
TGA presentation: medical devices audit assessmentsTGA Australia
An overview of the medical devices audit assessment process, including explanation about the difference between Level 1 and Level 2 audits and the information sponsors are generally required to provide.
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
Presentation: Clinical Evidence GuidelinesTGA Australia
This presentation provided an insight into the publication of the clinical evidence guidelines and an overview of clinical evidence requirements for medical devices. It also gave information about the level of clinical evidence required and the reason this level of evidence is required. Finally this presentation covered common errors made with clinical evidence.
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...
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
Devices Sponsor Information Day: Session 3B: Medical devices (IVDs) - applica...TGA Australia
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
Device Sponsor Information Day: Session 2: Clinical evidence - pre-market and...TGA Australia
This presentation provided an insight into the clinical evidence requirements for medical devices. It also gave information about the level of clinical evidence required for conformity assessment procedures and during application audits. Lastly, it outlined requirements to keep contemperaneous clinical evidence once a device is included in the ARTG.
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
Presentation: Recall of Therapeutic GoodsTGA 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.
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
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.
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.
A clinical investigation is defined as “any systematic investigation or study in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of medical device.”
The undertaking of a clinical investigation is a scientific process that represents one method of generating clinical data.
One of the purposes of a clinical investigation could be to establish and verify clinical safety, meaning to understand how to prevent and reduce risks, errors and harm that can happen to patients and personnel, such as doctors and nurses. The cornerstone of all clinical research is to provide a continuous improvement of treatment methods based on the understanding and learning from errors and adverse events detected.
Furthermore, the purpose of a clinical investigation can also be to establish and verify the performance of a device. This means checking the ability (or capability) of a device to perform as planned. This is done by looking at the technical, functional, or even diagnostic characteristics of the device. It needs to be verified whether it enables the manufacturer to achieve the intended purpose of the device and that it will lead to clinical benefits for patients.
Another purpose is to establish and verify clinical benefits, which is in its essence looking at the positive impact a device can have on the health of an individual. It is expressed in terms of a meaningful and measurable patient-focused outcome.
And finally, in the setting of a clinical investigation, side effects play a special role. One of the goals of a clinical investigation can be to gather additional information on the known side effects and to identify previously unknown side effects.
The overall purpose of a clinical investigation can be summed up to say that it is meant to translate scientifically tested innovations into clinical practice to provide patients with new (or improved) treatments.
A properly conducted clinical investigation, including compliance to the clinical investigation plan and local laws and regulations, ensures the protection of subjects, the integrity of the data and that the data obtained is acceptable for the purpose of demonstrating conformity to the Essential Requirements.
ISO 14155 outlines good clinical practice for clinical investigations of medical devices.
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
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.
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
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.
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.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
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Educo Life Science [gathering clinical evidence] [module 1]
1. Regulatory guidance and standards
for
gathering medical device clinical evidence
Dr Janette Benaddi
jbenaddi@outlook.com
2. • How does the regulation apply to gathering clinical
evidence?
• What guidance and standards need to be followed
when gathering evidence?
• Clinical evidence for different device classes and the
procedures relative to each
• What data, when, why, how?
• Clinical definitions and terminology
3. Hierarchy:
• MDR and IVDR
• Standards ISO 14155, ISO 20916
• MDCG
• Meddevs MEDDEV 2.7.1
• IMDRF
Regulations and Guidance
4. The Medical Device Regulations
The EU Regulation on Medical Devices 2017/745 MDR
The EU Regulation on In Vitro Diagnostic Medical
Devices 2017/746 IVDR
Various National requirements per country
5. Article 2 MDR
• (44) ‘clinical evaluation’means a systematic and planned process to continuously generate, collect,
analyse and assess the clinical data pertaining to a device in order to verify the safety and performance,
including clinical benefits, of the device when used as intended by the manufacturer;
• (51) ‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a
sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves
the intended clinical benefit(s), when used as intended by the manufacturer;
6.
7. MDR Chapter VI Article 61
Confirmation of conformity with relevant general safety and performance requirements set
out in Annex I under the normal conditions of the intended use of the device, and the
evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio
referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing
sufficient clinical evidence, including where applicable relevant data as referred to in
Annex II
8. MDR Chapter VI Article 61
• Manufacture to specify and justify level of clinical evidence required
• Plan, conduct and document a clinical evaluation
• Class III and IIb active devices intended to administer and/or remove a medicinal
product, prior to Clin Eval consult expert panel to review clin dev strategy
• Outlines what goes into to Clin Eval
10. Chapter VI Article 61
Implantable and Class III perform CI except if;
• Device has been designed by modifications of a device already marketed by
same manufacturer
• Modified device is equivalent to marketed device (endorsed by NB)
• And the CE of the marketed device is sufficient to demonstrate safety and
performance of the modified device
• In which case NB checks PMCFU is in place and post market studies
11. ANNEX XIV
• Contents of a clinical evaluation plan
• Take into account both favourable and unfavourable data
• May be based on an equivalent device technical, biological, clinical
• No clinical significant difference in the safety and performance of
equivalent devices
• Sufficient access to devices claimed to be equivalent
• All documented in a CER
• All to be included in the technical documentation
12.
13. • ISO 14155 - Clinical investigation of medical devices for human subjects — Good clinical practice
• The results of the clinical evaluation shall be used to determine and justify the optimal design of the
clinical investigation
• ISO 14971 – Medical devices — Application of risk management to medical devices
• Current knowledge of the material/medical device provided by scientific literature, previous clinical
experience and other relevant data should be reviewed to establish any need for additional data
• The manufacturer may gather and review data and literature to determine if the medical benefits of
the intended use outweigh the overall residual risk
Relevant Standards
14. • Guidance on how to conduct and document the clinical evaluation of a medical device as part of
the conformity assessment procedure prior to placing a medical device on the market as well as
to support its ongoing marketing.
• It is also intended to provide guidance to regulators and other stakeholders when assessing
clinical evidence provided by manufacturers.
European Commission MEDDEV. 2.7.1 Rev.4 - Clinical Evaluation: a guide for Manufacturers
And Notified Bodies (2016) 2.7.1 Rev.4
20. Document MDR Class Article/Annex Guidance
Clinical Development
Plan
All Annex XIV Part A (1) -
Clinical Evaluation Plan All Article 61 (1) MDCG 2020-6
Clinical Evaluation Report All Article 61 (1)
Annex IX Chapter II
Annex XIV Part A
MEDDEV 2.7/1 Rev4**
MDCG 2020-5 (Equivalence)
MDCG 2020-6 (Legacy Devices)
PMCF Plan All Annex XIV Part B MDCG 2020-8
PMCFR All Article 61 (11) (12)
Annex XIV Part B
MDCG 2020-8
PMS Plan All Article 84
Annex III (1.1)
-
Summary of safety and
clinical performance
Class III
and
implantabl
e
Article 32 MDCG 2019-9
Periodic safety update
report
IIa, IIb, III Article 86
Annex III (1.2)
In progress
21. Document IVDR Class Article/Annex Guidance
Performance Evaluation
Plan
All Article 56
Annex XIII Part A
MDCG 2020-6
Performance Evaluation
Report
All Article 56
Annex XIII Part A
MEDDEV 2.7/1 Rev4**
MDCG 2020-5 (Equivalence)
MDCG 2020-6 (Legacy Devices)
PMPFU Plan All Annex XIII Part B MDCG 2020-8
PMPFU Report All Article 61 (11) (12)
Annex XIII Part B
MDCG 2020-8
PMS Plan All Article 79
Annex III
-
PMSR A, B Article 80
Summary of safety and
performance
Class C, D Article 29 MDCG 2019-9 Summary of safety and
clinical performance a guide for
manufacturers and notified bodies
Periodic safety update
report
Class C, D Article 81
Annex
In progress spring
