Confusion is brewing over Europe' s medical device regulations, but it looks like last-minute measures could still prevent it and manufacturers can breathe a sigh of relief.

The EU has never been known for quick decision-making, and the long-awaited implementation of its new Medical Devices Regulation, which was introduced in 2017 but has not yet been fully implemented, is no exception.

The question is whether its provisions are still fit for purpose when analyzed in the context of a global pandemic such as the EU has never  seen before, and which was not expected when the details of the amendment were agreed.

But, regulators, legislators and manufacturers all agree that the new  rules are appropriate not only to  ensure safety but also to  encourage  innovation.

The European Medical Device Regulation (MDR) is intended to meet  this  test. However, the problem that is brought forward after the  disease is that the regulators and other institutions responsible for the  inspection of medical devices under the provisions of the law do not have the authority to continue the search. So the delay in implementation is a relief for all sectors.

A three-year transition period was  initially expected for the implementation of the MDR, but last month, the Commission listened to  the concerns of manufacturers and proposed an extension.

Understanding the current  situation  and  the  future timeline for change is important for the future planning of pharmaceutical technology developers  and  manufacturers.

The MDR replaces the European  Medical Device Directive (MDD). Changes introduced by the new  law include additional security and performance requirements, technical documentation, clinical data and  research  requirements. 

Legislative changes require all medical devices certified under the MDD to be recertified in accordance with the MDR by May 26,  2024.  However the gross lack of competence of the 'notified bodies' who are responsible for carrying out this work is an obstacle to progress that needs to be addressed urgently.

The notified body has received 8,120 applications from manufacturers and issued only 1,990 certificates under MDR. The number of MDR certificates expected to be issued by May 2024 may still reach only 7,000 if the current application rate continues  without changes in the 1793 certificates issued in the MDD process. The decision is very serious  and  the  alarm sounds good.

The Commission has proposed to extend the transition period for the certification of medical devices with deadlines based on the  device's  risk class: 2027 for class III and class IIb devices (devices in  high risk  category) and 2028 for class IIa and class. Instrument  I  (low  risk  instrument) which requires the involvement of a notified body in the conformity assessment.

Fortunately, the members of the European Council  supported  the Commission's proposal during the working session, Social Policy, Health and Consumer Affairs (EPSCO) on 9 December. In terms of other measures, the Commission's immediate objective is to submit a legislative proposal to the Council and the European Parliament for consideration. It must be done quickly.

The Medical Devices Committee of the Commission (MDCG) has also published a directory that aims to achieve a common and individual understanding in the application of article 97 of the MDR.

This article  provides  that  the  competent authorities can authorize the continued marketing of devices that do not comply with the MDR if they do not present an unacceptable risk to the health or safety of people. or public health. 

The position paper recommends  that members  apply the Article 97  safety valve in  situations where manufacturers make reasonable efforts to obtain certification under the MDR but a compliance assessment by the industry known not to close in time.

In the whole EU, and in fact  the  whole  world, wants to see a quick and effective regulation of medical devices, it is clearly necessary to take action to prevent the sector from reaching. But companies can't take their eyes off the ball.

Regulators and legislators have had years to see this problem coming, but, although it may be at the 11th hour, at least intervention at this time has prevented the problem.