Extension of the MDR transition period – do not stop working towards the certification!
The European Commission’s proposal to amend the transition time frames for certain Medical Devices and In vitro Diagnostics (IVDs) has recently been approved by the European Parliament.
- The extended transition period for high-risk devices, which are all Class III and implantable Class IIB devices, now ends on 31 December 2027.
- The transition period for medium and lower-risk devices ends on 31 December 2028.
- In addition, the transition period for Class III custom-made devices lasts until 26 May 2026.
For the device to qualify for the extension, there are four important conditions, which need to be fulfilled by the manufacturer:
- The manufacturer needs to submit an application for MDR technical documentation review to the Notified Body (NB) by 26 May 2024, and the application needs to be accepted by the Notified Body by 26 September 2024, by a contract.
- The manufacturer’s Quality Management System (QMS) must be MDR compliant by 26 May 2024
- The device must not present an unacceptable risk to health and safety, and
- No significant changes can be made to the device design during the transition period. The significance of the change is determined based on MDCG 2020-31, but as a short summary, it includes most design changes or changes to the intended use, indications for use or target patient population.
What does this mean for medical device manufacturers?
Most importantly, do not stop working towards the MDR certification or reduce resources allocated to MDR-related work because of the postponement.
The extension is mainly intended to give more time for Notified Bodies to review and approve the devices, and the manufacturer must be able to submit the technical documentation at any time after the agreement with the NB when the NB is ready to review it.
NBs cannot postpone all reviews to the last year of extension, as then a new bottleneck of reviews will form. If that happens, you don’t want to be in that last-minute crowd.
The documentation review times are close to one year after submission, and if you wait until the last year to do your submission, the review may not be finalized in time before the extension period ends.
Remember, during the extension period you cannot make any significant changes to your device as this will trigger the MDR certification. However, you may still take corrective actions for safety based on a separate assessment.
Note also that the need to make changes for devices sold in other jurisdictions while keeping them unchanged in the EU may create issues for the maintenance of the product portfolio.
All MDR requirements concerning Post Market Surveillance (PMS) data gathering and reporting still apply even though the transition time frame has been pushed forward. Notified bodies will still be conducting surveillance audits for technical documentation as well as for the QMS.
The expectations around clinical data submission for the MDR will remain unchanged. The good thing is that now you have a little bit more time to generate the required high-quality Post Market Clinical Follow up (PMCF) data.
The number of Notified Bodies is limited and so is the capacity of each Notified Body. Their capacity will be fully occupied until the end of the extension periods. Remember, IVD manufacturers will soon be knocking on the same NB’s door, as the IVDR transition time now overlaps with the MDR transition time!
The purpose of the transition period extension is to ensure that critical medical devices remain available on the EU market. Especially, the removal of the sell-off date is intended to ensure that warehouses in the EU are adequately stockpiled.
This extension period is not intended to allow manufacturers to sit back and relax but to give them the possibility to compile as well-prepared and complete technical documentation as possible, which in turn will speed up their review process and reduce resource needs at the NB.
So, to secure your place in the NB’s review queue, continue allocating resources to the MDR submission and be prepared and compliant as soon as possible!