Did extension of the EU Medical Device Regulations (MDR) really give you more time?

The EU MDR transition period began on May 26th of 2021, and this decision has been in force since then. The transition for the MDR was scheduled to end on May 26th of 2024, but there are serious concerns that most of the CE Certificates will not be re-issued before that deadline.

Now there is an extension of the MDR and IVDR transition deadlines. The extension of the implementation period is not for new devices, it is only for medical devices covered by a certificate, or a declaration of conformity issued before 26 May 2021. For those devices ONLY the implementation deadline has been pushed back to December of 2027 for high-risk devices such as pacemakers and hip implants (class III). Low and medium risk devices such as syringes and re-usable surgical instruments have until December of 2028.

The extension introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024. This means that you will need to have a signed contract from a notified body… That is until EUDAMED is live, because when this module comes into force it will need to be filed electronically through EUDAMED.

If by chance you happened to have a certificate that was valid on 26 May 2021, the validity of that certificate has been extended. If approved this will also remove the ‘sell-off’ date of currently established in the MDR and IVDR. This is the date that would have required devices still on the shelf to be sold off or removed by a specific date.

Now is the time to make sure that your quality system meets the new requirements.