The Regulation (EU) 2017/745 (also known as MDR) transition time of three years is about to end – by May 26th 2020 manufacturers of currently approved medical devices need to meet the requirements of the regulation.
However, a lot of questions on the compliance procedures have emerged during this transition period. In order to support manufacturers on this road to compliance, seQure 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 the 25th of May 2017 and allows transition time for medical device manufacturers to be compliant with a final deadline of 26th of 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.
What is the advantage of having a Post Market Surveillance integrated with risk evaluation?
Post Marketing Surveillance integrated with risk evaluation allows to minimize risks or prevent incidents related to medical devices, by establishing a system for risk management and a system for reporting of incidents and field safety corrective actions.
How can a Medical Device manufacturer improve Risk Management through a good Post Market System?
Manufacturers of devices, other than investigational devices, can improve the Risk Management by establishing, documenting, implementing, maintaining, keeping up to date and continually improving the Quality Management System, in order to ensure compliance with MDR in the most effective manner and in a manner that is proportionate to the risk class and the type of the medical device.
Do certificates issued by notified bodies in accordance with the Directives prior to 25 May 2020 remain valid after the date of application of the MDR?
In Art. 120 dedicated to transitional provisions, the 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.
Where can I find more information on the 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 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.
Do you have questions related to the MDR or seQure services? Contact us via the website form and we will get back to you as soon as possible.