The document discusses new EU regulations that replace medical device directives. Regulation EU 2017/745 deals with medical devices and Regulation 2017/746 covers in vitro diagnostic medical devices. Both regulations were published in April 2017 and provide transition periods until 2020 and 2022, respectively. The new regulations aim to better protect public health and patient safety.
The key differences between the MDR and IVDR in the EUAdamsBrown4
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
https://mavenprofserv.com/comparison-and-highlighting-of-the-key-differences-between-the-mdr-and-ivdr-in-the-eu/
The key differences between the MDR and IVDR in the EUJonesmiller3
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
https://mavenprofserv.com/comparison-and-highlighting-of-the-key-differences-between-the-mdr-and-ivdr-in-the-eu/
The EU’s Medical Device Regulation (MDR) is a hot topic in
healthcare since it was officially published on 5th May 2017
and came into effect on 25 May 2017. The MDR replaces the
EU Medical Device Directive (93/42/EEC) and the Directive
on active implantable medical devices (90/385/EEC).
The key differences between the MDR and IVDR in the EUAdamsBrown4
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
https://mavenprofserv.com/comparison-and-highlighting-of-the-key-differences-between-the-mdr-and-ivdr-in-the-eu/
The key differences between the MDR and IVDR in the EUJonesmiller3
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
https://mavenprofserv.com/comparison-and-highlighting-of-the-key-differences-between-the-mdr-and-ivdr-in-the-eu/
The EU’s Medical Device Regulation (MDR) is a hot topic in
healthcare since it was officially published on 5th May 2017
and came into effect on 25 May 2017. The MDR replaces the
EU Medical Device Directive (93/42/EEC) and the Directive
on active implantable medical devices (90/385/EEC).
Medical devices play a crucial role in modern healthcare, encompassing a vast array of instruments, equipment, implants, and software used for diagnosis, treatment, monitoring, and rehabilitation. From simple tools like thermometers and stethoscopes to complex devices such as MRI machines and pacemakers, medical devices contribute to improving patient outcomes, enhancing quality of life, and advancing medical innovation. In this discussion, we explore the significance, types, regulation, challenges, and future trends of medical devices.
First and foremost, medical devices are indispensable assets in healthcare delivery, enabling clinicians to diagnose diseases, perform procedures, and manage patient care effectively. Diagnostic devices, including X-ray machines, ultrasound scanners, and blood glucose monitors, provide critical information for accurate diagnosis and treatment planning. Therapeutic devices, such as ventilators, defibrillators, and prosthetic limbs, aid in managing acute and chronic conditions, restoring function, and alleviating symptoms. Monitoring devices, such as cardiac monitors, continuous glucose monitors, and wearable fitness trackers, facilitate real-time assessment of patient health and enable early intervention when necessary. Additionally, surgical instruments, implants, and assistive devices enhance surgical precision, promote tissue repair, and improve mobility and independence for individuals with disabilities.
The landscape of medical devices is diverse and constantly evolving, encompassing a wide range of technologies and applications. Common categories include diagnostic imaging devices, in vitro diagnostic (IVD) devices, surgical instruments, dental equipment, orthopedic implants, cardiovascular devices, ophthalmic devices, and more. Furthermore, advances in digital health technologies have led to the development of connected medical devices, telemedicine platforms, health monitoring apps, and wearable sensors, revolutionizing the delivery of healthcare services and empowering patients to take an active role in their health management.
Given the critical role they play in patient care, medical devices are subject to stringent regulation to ensure safety, efficacy, and quality standards. In the United States, the Food and Drug Administration (FDA) oversees the regulation of medical devices through a comprehensive framework that includes premarket approval, post-market surveillance, quality systems regulation, and adverse event reporting. Similarly, regulatory bodies in other countries, such as the European Union's CE marking system and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), enforce standards and requirements to ensure the safety and effectiveness of medical devices sold in their respective markets.
Despite their numerous benefits, medical devices also present certain challenges and considerations. These include concerns related to device interoperability and integration with healthcare
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
1. This Circular elaborates Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices (hereinafter referred to as “Decree No. 98/2021/ND-CP”).
a) Classification of medical devices under Clause 5 Article 5 of Decree No. 98/2021/ND-CP;
b) Addition to the list of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities under Point dd Clause 3 Article 30 of Decree No. 98/2021/ND-CP;
c) List of class B, class C, and class D medical devices purchased and sold as common commodities mentioned under Clause 1 Article 42 of Decree No. 98/2021/ND-CP;
d) List of medical devices to be inspected for safety and technical functions under Clause 10 Article 70 of Decree No. 98/2021/ND-CP;
dd) List of medical devices to be granted import permit under Point d Clause 2 Article 76 of Decree No. 98/2021/ND-CP.
2. Annuls documents on management of medical devices.
Insights about changes to the EU's MDR (Medical Device Regulations) by Ulf Grundmann, Partner, King & Spalding, August 17, 2020. Includes scope and definitions, classification and conformity assessment, placing a device on the EU marketin, UDI and EUDAMED, supply chain obligations, PMS, compliance and vigilance.
A No-Deal Brexit and the Impact on Medical DevicesEMMAIntl
High risk medical devices are certified by an independent conformity assessment conducted by notified bodies (NB). The notified bodies are overseen by the national authority of each member state in the EU, and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. NBs are also subjected to European commission audits...
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
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)
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Medical devices play a crucial role in modern healthcare, encompassing a vast array of instruments, equipment, implants, and software used for diagnosis, treatment, monitoring, and rehabilitation. From simple tools like thermometers and stethoscopes to complex devices such as MRI machines and pacemakers, medical devices contribute to improving patient outcomes, enhancing quality of life, and advancing medical innovation. In this discussion, we explore the significance, types, regulation, challenges, and future trends of medical devices.
First and foremost, medical devices are indispensable assets in healthcare delivery, enabling clinicians to diagnose diseases, perform procedures, and manage patient care effectively. Diagnostic devices, including X-ray machines, ultrasound scanners, and blood glucose monitors, provide critical information for accurate diagnosis and treatment planning. Therapeutic devices, such as ventilators, defibrillators, and prosthetic limbs, aid in managing acute and chronic conditions, restoring function, and alleviating symptoms. Monitoring devices, such as cardiac monitors, continuous glucose monitors, and wearable fitness trackers, facilitate real-time assessment of patient health and enable early intervention when necessary. Additionally, surgical instruments, implants, and assistive devices enhance surgical precision, promote tissue repair, and improve mobility and independence for individuals with disabilities.
The landscape of medical devices is diverse and constantly evolving, encompassing a wide range of technologies and applications. Common categories include diagnostic imaging devices, in vitro diagnostic (IVD) devices, surgical instruments, dental equipment, orthopedic implants, cardiovascular devices, ophthalmic devices, and more. Furthermore, advances in digital health technologies have led to the development of connected medical devices, telemedicine platforms, health monitoring apps, and wearable sensors, revolutionizing the delivery of healthcare services and empowering patients to take an active role in their health management.
Given the critical role they play in patient care, medical devices are subject to stringent regulation to ensure safety, efficacy, and quality standards. In the United States, the Food and Drug Administration (FDA) oversees the regulation of medical devices through a comprehensive framework that includes premarket approval, post-market surveillance, quality systems regulation, and adverse event reporting. Similarly, regulatory bodies in other countries, such as the European Union's CE marking system and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), enforce standards and requirements to ensure the safety and effectiveness of medical devices sold in their respective markets.
Despite their numerous benefits, medical devices also present certain challenges and considerations. These include concerns related to device interoperability and integration with healthcare
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
1. This Circular elaborates Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices (hereinafter referred to as “Decree No. 98/2021/ND-CP”).
a) Classification of medical devices under Clause 5 Article 5 of Decree No. 98/2021/ND-CP;
b) Addition to the list of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities under Point dd Clause 3 Article 30 of Decree No. 98/2021/ND-CP;
c) List of class B, class C, and class D medical devices purchased and sold as common commodities mentioned under Clause 1 Article 42 of Decree No. 98/2021/ND-CP;
d) List of medical devices to be inspected for safety and technical functions under Clause 10 Article 70 of Decree No. 98/2021/ND-CP;
dd) List of medical devices to be granted import permit under Point d Clause 2 Article 76 of Decree No. 98/2021/ND-CP.
2. Annuls documents on management of medical devices.
Insights about changes to the EU's MDR (Medical Device Regulations) by Ulf Grundmann, Partner, King & Spalding, August 17, 2020. Includes scope and definitions, classification and conformity assessment, placing a device on the EU marketin, UDI and EUDAMED, supply chain obligations, PMS, compliance and vigilance.
A No-Deal Brexit and the Impact on Medical DevicesEMMAIntl
High risk medical devices are certified by an independent conformity assessment conducted by notified bodies (NB). The notified bodies are overseen by the national authority of each member state in the EU, and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. NBs are also subjected to European commission audits...
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
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)
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
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.
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.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
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.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
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.
1. NEW MEDICAL DEVICE
REGULATIONS- MDR
Published by European Parliament and
Council of European Union
Mary Roopsy
www.i3cglobal.com
mrj@i3cglobal.com
2. Two new regulations that replace the medical device
directives are
Regulation EU 2017/745 which replaces on medical
devices, amending Directive 2001/83/EC, Regulation
(EC) No 178/2002 and Regulation (EC) No 1223/2009
and repealing Council Directives 90/385/EEC and
93/42/EEC
Mary Roopsy
mrj@i3cglobal.com
3. Regulation 2017/746 on in vitro diagnostic medical
devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU
Mary Roopsy
mrj@i3cglobal.com
4. These new MDR are released on April 5, 2017 and a
transition period of 3 years , i.e 2020 for the medical
devices and 5 years, i.e 2022 for the in vitro diagnostic
medical devices are allowed. Through these new regulations
the EU commission aims at the better protection of public
health and patient safety.
Mary Roopsy
mrj@i3cglobal.com
