Wien, 20.03.2023 – MDR extension deadline: it’s set in stone!
The European Parliament has just published in the Official Journal of the European Union the extension of the transition period for full application of the Medical Device Regulation (MDR).
The European Parliament adopted a proposal by the European Commission to delay the transition period due to concerns about device supply, notified body capacity and manufacturer preparedness.
Although notified bodies (NBs) have been ramping up capacity and the number of MDR designated NBs keeps on growing, the capability to process applications is not endless. The amendment is actually not intended to give industry more time; but to only give NBs a longer period to process the huge pile of applications that had amassed towards the end of the grace period. As such, any manufacturer that misunderstands this fact, is making a critical mistake and will miss its launch window for extension, inevitably leading to a period of not being able to place devices on the market in the Union until MDR CE mark has been obtained.
In fact, the application of the extended transition period is subject to several cumulative conditions, in order to ensure that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR will benefit from the additional time,
As such, the transition period deadline is extended from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the device. High-risk devices are subject to the shorter transition period ending in 2027; while low- and medium-risk devices, will have until the end of 2028 to complete a conformity assessment.
For class III custom-made implantable devices, the Commission created a new transition period until 26 May 2026, to give manufacturers more time to get their quality management systems (QMS) certified by a notified body. For such manufacturers, the new transition period will only apply if the company has registered to a notified body by 26 May 2024, and has signed a contract for the certification by 26 September 2024.
Regarding the deletion of the sell-off date provision, the Commission said the measure will reduce the risk of shortages by allowing devices and IVDs that were already on the market based on compliance with the former directives to remain on the market. The Commission noted that the provision would not allow devices with a limited shelf-life to be offered past expiration.
Passage of the amendment may also have some unintended consequences, since some companies have slowed their pace to comply with the regulation already expecting an extension. The best thing to do is to continue to push for completion and provide the notified body with timely dossiers for review.
First and foremost, it is important that manufacturers ensure that they are generating sufficient clinical data and try get the product submission right the first time, so not to delay the process.
Since the amendment is a very technical document, the European Commission is already working on a Q&A article that they plan to present to stakeholders during March to help resolve any questions regarding interpretations.
As such, let’s all work together – Member States, notified bodies and industry, to ensure a smooth transition to the new rules without further delay.
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