MDR transition period is changed
Begin January, the EU Commission formalized the proposal to update Art. 120, Art. 122 and Art. 123 of the MDR 2017/745. This has been done with intention of giving Notified Bodies (NoBo’s) more time to certify manufacturers and so that (legacy device) manufacturers intending to transition to the MDR, will benefit from the extended transition period.
The length of the proposed extension of the transition periods mainly depends on the decision to proceed with MDR certification.
If choosing to continue selling devices under the MDD (93/42/EEC)
The proposal deleted Article 120(4) of the MDR pertaining to the ‘sell-off’ date, meaning the date of May 26th, 2025 does not apply anymore. Now, the cut-off date for placing MDD compliant devices is now dependent on the efforts to transition to the MDR.
Should our potential clients wish to continue selling MDD devices WITHOUT taking the effort to transition to the MDR and meeting the transitional conditions, they will only be allowed to place on the market devices certified under the MDD, until May 26th, 2024. Provided, of course, that the devices (design, risk class, intended purpose etc) and manufacturing and quality processes have not changed.
If proceeding with MDR 2017/745 transition
The transition periods listed below ONLY apply to devices that are undergoing the transition to the MDR (legacy devices = devices previously certified under MDD), the following dates apply:
- For medium and lower risk (Class IIa & Class Ir/s/m) such as syringes or reusable surgical instruments, December 31st, 2028 applies.
- For higher risk devices (Class IIb & III) for example pacemakers and hip implants, the date of December 31st, 2027 applies.
Need some help?
As indicated, the European Commission submitted the proposal in early January 2023. The proposal still needs to be approved by the European Parliament and the Council through an accelerated codecision procedure. Certification Company is of course following developments closely. Do you have questions? Please contact us, our experts would be happy to assist you!