What Happened?

The Medical Device Regulation (MDR 2017/745) came into force on May 26, 2021. The transition period for CE certificates issued under the Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC) was about to end on May 26, 2024.1 An amendment to extend the transition period for medical devices was proposed to the European Commission in January 2023 to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework.1 The European Commission agreed with the proposed amendment, and with the publication in the Official Journal of the European Union, it is official and effective from March 20, 2023, onward.2  

What Does This Mean? 

The length of the extended transition period depends on the risk class of the medical devices concerned, i.e., the transition period is shorter for devices belonging to a higher-risk class and longer for devices belonging to a lower-risk class. The transition date for Class III custom-made implantable devices is extended to May 26, 2026, for all Class III and for most Class IIb devices (devices that do not classify as well-established technology) December 31, 2027, and for the remainder of Class IIb, Class IIa, and Class Im, Is and Ir risk devices December 31, 2028. Details for each device classification can be found in paragraph 3 of Article 1 of the amendment.2  

To Which Devices Does This Apply? 

These dates apply to medical devices that: 

  • Had a valid MDD/AIMDD certificate on May 26, 2021
  • Have not been withdrawn by a Notified Body.  
  • Had a formal application lodged with a Notified Body for conformity assessment no later than May 26, 2024, for which a written agreement has to be signed by the manufacturer and Notified Body no later than September 26, 2024.  
  • Had no significant changes in the device’s design or its intended purpose, and in case the device does not present unacceptable health or safety risks. Furthermore, the manufacturer has to put a quality management system into practice no later than May 26, 2024.2 

Under certain circumstances, MDD/AIMDD certificates that were still valid on May 26, 2021, but that had expired before March 20, 2023, will now be considered valid until the extended transition dates.2 

Devices for which the conformity assessment procedure did not require the involvement of a Notified Body as determined prior to May 26, 2021, but do require a Notified Body under the MDR, may be placed on the market or put into service until December 31, 2028.2 

Removal of “Sell-Off” Period in MDR 

Besides the extended transition dates, the “sell-off” period in the MDR will be removed and will be changed to unlimited in time to overcome the shortage of available medical devices. This means that it is no longer prohibited to marketed devices or to put devices into service that were placed on the market by the end of the applicable transition period.2 

How Can Avania Help? 

This development gives manufacturers the opportunity to be sufficiently prepared to meet the requirements of the MDR. In addition, this will provide Notified Bodies time to increase their capacity to carry out the tasks required of them. All in all improving innovation, business activity, and hopefully, addressing the risk of reduced availability of medical devices on the EU market. 

If you have questions regarding a specific case, please reach out and find out how we can assist. 

References

1 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

2 REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

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