More time to certify medical devices - it's official!
Just published in the EU's Official Journal: there will be a longer transition period to adapt to the new MDR (2017/745) and IVDR (2017/746) rules.
Importantly, the new deadlines depend on the medical devices' risk class: higher risk devices such as pacemakers and hip implants will benefit from a shorter transition period (until December 2027); and, medium and lower risk medical devices, such as syringes or reusable surgical instruments (until December 2028).
Key elements:
- For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
- The proposal 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.
- To reflect the transition periods put forward by these amendments, the validity of certificates issued up until 26 May 2021 is extended, the day when the Medical Devices Regulation became applicable.
- The Commission will also remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need. Of course, expired devices are not included.
- Transfer of appropriate surveillance to MDR Notified Bodies (NBs) until September 2024, at the latest.
- Introduction of a temporary derogation until 26 May 2026 from requirement for Quality Management System (QMS) certificate for Class III implantable custom-made devices, subject to conditions.
Importantly, the new deadlines depend on the medical devices' risk class: higher risk devices such as pacemakers and hip implants will benefit from a shorter transition period (until December 2027); and, medium and lower risk medical devices, such as syringes or reusable surgical instruments (until December 2028).
Key elements:
- For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
- The proposal 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.
- To reflect the transition periods put forward by these amendments, the validity of certificates issued up until 26 May 2021 is extended, the day when the Medical Devices Regulation became applicable.
- The Commission will also remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need. Of course, expired devices are not included.
- Transfer of appropriate surveillance to MDR Notified Bodies (NBs) until September 2024, at the latest.
- Introduction of a temporary derogation until 26 May 2026 from requirement for Quality Management System (QMS) certificate for Class III implantable custom-made devices, subject to conditions.
An important note: even though the deadlines can be extended, the new deadlines will only apply if the manufacturer has started the Notified Body MDR/IVDR application process before 26 May 2024 and has signed a contract with a NB until September 2024.
So, if you need help with the Clinical Evaluation Report (CER) of your device or compiling the Technical File, don't waist more time - contact us, we at BioSciPons can be of service!
Catarina Carrão