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May 2024: deadline to enjoy MDR transitory period extension gets close

Le imminenti scadenze di Maggio per MDR

Regulation (EU) 2023/607 was published a year ago, changing articles 120, 122 and 123 of Regulation (EU) 2017/745 (MDR), further extending the transitory period for the passage from previous directives to the regulation.

The time extension only applies to legacy devices, i.e. those class I medical devices (MD) as per directive 93/42/EEC (MDD) whose declaration of conformity was drafted before 26 May 2021 and for which the procedure to assess MDR conformity involves a notified body (NB), or those MD covered by a valid CE certificate released by a notified body according to the MDD or to Directive 90/385/EEC (AIMDD) before 26 May 2021.

So far, legacy devices manufacturers whose certificate expired after 20 March 2023 (for certificates expired before this date it is required that the conditions of the new art. 120, sect. 2, lett. a or b of the MDR are met) or will expire within 26 May 2024, were able to keep placing their products on the market, under the de jure extension of validity of the above certificates established in Regulation (UE) 2023/607.

Conditions for extension until May 26, 2024

The only conditions to be met to automatically extend the validity of expired certificates or those about to expire within 26 May 2024 are the following:

  • that the devices are still compliant with the AIMDD or MDD, depending on the case;
  • that no significant change has been introduced in the design or intended use;
  • that the devices do not present an unacceptable risk for the health or safety of patients, users or other people, and for other aspects of public health protection.

On the other hand, according to Regulation (EU) 2023/607, 2024 is the first true stumbling block in terms of time for MDR compliance.

In fact, in order to enjoy the extension provided for by this regulation, within the now imminent date of 26 May 2024, manufacturers (or authorised representatives) must comply with two more important conditions:

  • they must have set up a quality management system in compliance with the MDR;
  • they must have submitted an official application to a notified body in compliance with annex VII, 4.3, first paragraph of the MDR, for the assessment of the conformity of a device according to the MDR (or alternatively of a device intended to replace such device).

Preparatorily, manufacturers must also consider a further very close deadline, that is:

  • within 26 September 2024 the notified body and the manufacturer must have signed a written agreement in compliance with annex VII, 4.3, second paragraph of the MDR.

Only by performing these activities within the established deadlines manufacturers can be sure that their MDs can benefit from the deadlines for the marketing provided for by the provisions of Regulation (EU) 2023/607, as follows:

  • within 26 May 2026 for class III implantable custom-made MDs;
  • within 31 December 2027 for class III MDs and class IIb implantable MDs (except for the so called “WET”);
  • within 31 December 2028 for other class IIb MDs, for class IIa MDs, for class I MDs that are sterile or have a measuring function.

Class I devices that are not subject to a class upgrade based on the MDR rules do not enjoy the time extension as they do not fall into the category of legacy devices and should have already been fully compliant on 26 May 2021.

It should be specified that the risk class to consider to establish the applicable timeframe is that given by the classification resulting from the application of the rules of annex VIII of the MDR and not by the classification as per previous directives.

This aspect, added to the need of applying an MDR QMS and sign an agreement with a NB for the conformity assessment according to the Regulation within the deadlines scheduled in the next few months, stresses the fact that legislators have granted this time extension provided that manufacturers start immediately to manage their products in the perspective of the new regulatory framework.

Based on the new classification rules, many devices will be upgraded to a higher risk class in the passage to the new regulatory framework (starting with those including substances, by reason of the considering 59 and rule 21), with a consequent need to provide more evidence and supporting documentation, as requested by the stricter requirements defined by the MDR.

In view of the imminent deadlines, Di Renzo Regulatory Affairs has organised its first Meet & Greet, a free event dedicated to all companies operating in the sector of medical devices and scheduled on 18 April 2024. The event includes 30 minutes of free on line advice in a one-to-one meeting with one of our experts, during which it will be possible to define together the best strategy to be adopted to start your project or overcome a critical phase and easily go ahead towards MDR conformity!

Written on 03/20/2024 by Simone Pippa