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Enforcement request

Transitional periods for the MDR

The European Medical Device Regulation (MDR) imposes stricter requirements on medical devices. Transitional periods have been set by which date the medical devices must meet these requirements. These transitional periods have been extended by a postponement regulation that took effect in March 2023.

Longer transitional periods

Regulation 2023/607 was published on 20 March 2023. This regulation postpones the transitional periods under the MDR. A longer transitional period applies depending on the risk class of the medical device. As a result, CE certificates issued under directives 90/385/EEC (AIMDD) or 93/42/EEC (MDD) will no longer expire on 26 May 2024. This concerns CE certificates that were valid on the date of application of the MDR, 26 May 2021, and that have not been withdrawn by a notified body.

Impact on pending Article 97(1) applications

On 9 December 2022, the European Medical Device Coordination Group (MDCG) published a position paper: MDCG 2022-18. The paper sets out measures with which the competent authorities aim to prevent medical device shortages resulting from the expiry of CE certificates under the MDD and AIMDD. These measures are designed to bridge the period between the expiry of these CE certificates and certification under the MDR.

From the publication of this position paper, it was clear that this was a temporary measure. This measure would last until the legislative proposal to postpone the transitional periods under the MDR came into effect. Now that this has happened due to Regulation 2023/607, decisions previously taken on the basis of Articles 97(1) and MDCG 2022-18 are no longer valid. The postponement of the transitional periods from the MDR renders these decisions redundant.

The Health and Youth Care Inspectorate (IGJ) will only process new applications for a measure on the basis of Article 97(1) if that measure is necessary in order to meet the conditions for the extended transitional period. In that case, you must meet the following conditions: 

  • The CE certificates must have been issued on or after 25 May 2017 by a notified body in accordance with the MDD or AIMDD, must have been valid on 26 May 2021 and must not have been withdrawn after that date;
  • As a manufacturer, you must have failed to sign a written agreement for the MDR conformity assessment with a notified body before the expiry date of the MDD/AIMDD CE certificate, despite reasonable efforts. This assessment concerns the medical device to which the expired CE certificate relates, or another medical device intended to replace the current medical device.

In the case of new applications, the Health and Youth Care Inspectorate will, in the first instance, assess whether you meet the above criteria for the processing of the application. All conditions set out in MDCG 2022-18 for the application of Article 97(1) also remain applicable.

Application

You can send the completed ‘Article 97 enforcement request’ application form to the email address of the CIBG's Farmatec department: CIBGartikel97@minvws.nl stating ‘Article 97 enforcement request’ in the subject line.

Procedure

If your application is incomplete, you will be asked to complete it. Once the application is complete, you will receive confirmation of receipt and the application will be sent to the Health and Youth Care Inspectorate for assessment and a decision. The Health and Youth Care inspectorate is the authority in the Netherlands with the power to apply Article 97 of the MDR and will reach a decision on your application.