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MDR transition period is changed

30.01.2023

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.

Risk class of medical devicesWhat is the risk class of my medical device?

Medical devices are divided into four categories or classes, from the lowest to the highest risk class. The higher the risk for the patient/end-user, the higher the risk category. READ MORE

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.
IMPORTANT! These extension dates do not mean that clients can delay the MDR certification process. The above-mentioned extensions are subject to cumulative conditions as highlighted on page 8 of the Amendment.

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!

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