An amendment to the Regulation (EU) 2017/745 (also known as MDR) was adopted on 24 April 2020 by European Commission, which postponed the application of most of its provisions by one year, until 26 May 2021. Originally, the manufacturers of currently approved medical devices needed to meet the requirements of the regulation by May 26 2020.
A lot of questions on the compliance procedures have emerged during the transition period. In order to support manufacturers on this road to compliance, seQure, the business unit of Arithmos, has answered some of the common questions we have heard from clients and industry colleagues.
What is the MDR and why is it an important topic?
The Medical Device Regulation or MDR is a regulation that replaces the Council Directives 93/42/EEC and 90/385/EEC. It came into force on 25 May 2017 and originally allowed transition time for medical device manufacturers to be compliant with a final deadline of 26 May 2020.
This Regulation aims at ensuring the smooth functioning of the internal market as regards medical devices. It focuses on a high level of protection of health for patients and users. MDR sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.
Why is Post Market Surveillance an important part of the Medical Device Regulation?
Systematic monitoring of the post market surveillance system is necessary in order to ensure detection of risk and the implementation of the action to control it, ensuring that the safety profile of the medical device product is always updated.
Do certificates issued by notified bodies in accordance with the Directives prior to 25 May 2020 remain valid after the date of application of MDR?
In Art. 120 dedicated to transitional provisions, MDR specifies that certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2017 remain valid until the end of the period indicated on the certificate. The only exception is certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which will become void at the latest on 27 May 2022.
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, but it cannot exceed five years from its issuance. They will become void at the latest on 27 May 2024.
Why was MDR delayed by a year?
Originally, the anticipated date of application date of MDR was 26 May 2020. However, it has been postponed by one year due to the COVID-19 pandemic.
An amendment to the MDR was adopted on 24 April 2020 by European Commission, which postponed the application of most of its provisions by one year, until 26 May 2021.
However, the application date of the “In Vitro Diagnostics Medical Devices Regulation” (IVDR) remains unchanged. IVDR will become applicable on 26 May 2022, as expected.
What is EUDAMED and how its launch was impacted by the COVID-19 pandemic?
EUDAMED is the European database of Medical Devices and has been developed with the aim of strengthening market surveillance and transparency with regards to Medical Devices placed on the European market.
As a result of the COVID-19 pandemic, the amending regulation also modified the date on which the European Commission is obliged to publish a notice that EUDAMED is fully functional.
If European Commission will not publish this notice by 26 May 2021, the obligations and requirements provided for by the MDR relating to EUDAMED will apply from the date corresponding to six months after the European Commission has published its notice.
Did COVID-19 impact the process of appointing the Notified Bodies under the MDR?
Currently (08.07), there are 15 authorized Notified Bodies – the updated list is available on the website of the European Commission. The appointment process continues even under current circumstances.
However, due to COVID-19 outbreak, Notified Bodies face challenges in calibration, testing, certification and inspection. In order to cope with these challenges, European Commission’s Medical Device Coordination Group (MDCG) in April issued a guidance to help Notified Bodies perform audits during the pandemic period, including remote audits in some cases.
What is the advantage of having a Post Market Surveillance integrated with risk evaluation?
The advantage of such approach is that it provides the evidence that the Medical Device is safe and effective, without compromising the clinical condition or the safety and health of patients, users or, where applicable, of other persons.
If the Post Market Surveillance system is integrated with risk evaluation, any risks, potentially associated to the use of the Medical Device, is declared and could be acceptable if compared to its benefits and with a compatible high level of protection for what concerns both health and safety.
How can a Medical Device Manufacturer improve Risk Management through Post Market System?
In order to improve its Risk Management System, the medical device manufacturer shall be able to estimate risks associated with the intended use of the medical device, as well as with a reasonably foreseeable misuse.
The Risk Management System shall be evaluated in the Post Market Surveillance system, focusing on hazards and frequency of risks occurrence.
Where can I find more information on MDR?
The following sources can come handy:
- European Commission, New Regulations in Medical Device;
- Factsheet for Manufacturers of Medical Devices;
- Implementation Model for Medical Devices Regulation – Step by Step Guide;
- EMA, Interface between medicinal product and medical devices development – Update on EMA implementation of the new medical devices legislation;
- The list of the MDR Notified Bodies;
How can seQure, the business unit of Arithmos, support medical device manufacturers on the road to compliance?
seQure can support medical device companies on the journey for the implementation and maintenance of their quality systems to be in compliance with MDR 2017/745 and technology including MDR compliant EDC, safety system and document management system.
