MDR/IVDR Amending Regulation published

Following last week’s formal approval of the European Commission’s proposal to extend the transition timelines for certain ‘legacy devices’ and eliminate the ‘sell-off period’ from the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746), Amending Regulation (EU) 2023/607 has now been published.

The Preamble to the Regulation states, as industry has been complaining for some time, that:

“Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with [the AIMDD and MDD] before 26 May 2024.”

And:

“Therefore, it is very likely that many devices that can lawfully be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017/745 will not be certified in accordance with that Regulation before the end of the transitional period, which leads to the risk of shortages of medical devices in the Union.”

Under certain specific circumstances, therefore, the Amending Regulation allows existing AIMDD/MDD CE certificates to remain valid until 31 December 2027 for (a) “all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors”, and until 31 December 2028 for (b) “class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.”

Class III custom made devices will, however, need to fully comply with the MDR by 26 May 2026.

In addition, the sell-off provisions specified in MDR Article 120(4) and IVDR Article 110(4) have been abolished to allow medical devices already placed on the market under the Directives to be made further available without an end date.

The Amending Regulation came into immediate effect upon signing on 15 March 2023.

It is expected that an explanatory Q&A document will soon follow. It is anticipated that this will also include a bonus for manufacturers who are not planning to transition their AIMDD/MDD compliant devices to MDR compliance, and for which the certificates expire between now and 26 May 2024, in that for the devices included in (a) and (b) above, their CE certificate validity will automatically be extended until 26 May 2024, as long as:

(a) those devices continue to comply with AIMD or MDD, as applicable;
(b) there are no significant changes in the design and intended purpose;
(c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.

Watch this space for more news when the guidance has been published.