(01/2020) After the Council of the European Union had presented it, on December 3, 2019 the committee responsible for environmental issues, public health and food safety of the European Parliament decided on a so-called corrigendum to the European Medical Device Regulation MDR (short link: https: / /bit.ly/2KXHfeZ, German version from page 25).
Accordingly, the transition period for certain Class I products can be extended by four years until May 26, 2024. Class I products that have to go through safety checks for the first time due to a higher classification are affected - i.e. products of classes Ir (reusable surgical instruments) Is (sterile) and Im (metrological). Now the EU Commission still has to submit an amending regulation to the MDR and then vote on it by the EU Parliament and Council.
Medical devices of the future class Ir, for which a declaration of conformity according to the previous MDD was drawn up before May 26, 2020, may now also be placed on the market until May 2024. On the one hand, this takes account of the current lack of notified bodies and, on the other hand, eliminates the unequal treatment compared to higher risk classes. The corrigendum becomes completely official after it has been read out and announced in the entire EU Parliament.
Concrete clarification
Specifically, it concerns the correction of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation (EC) No. 178/2002 and the Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC. According to the corrigendum, Article 120 (3) should now read as follows (changes are highlighted): "Notwithstanding Article 5 of this Regulation, a product that is a class I product according to Directive 93/42 / EEC may be used before the 26th . May 2020 an EU declaration of conformity has been drawn up and for which the conformity assessment procedure in accordance with this regulation requires the involvement of a notified body or for which there is a certificate in accordance with Directive 90/385 / EEC or Directive 93/42 / EEC, which pursuant to Paragraph 2 of this article is valid until May 26, 2024, provided that it continues to comply with one of these directives from May 26, 2020 and [...] "In addition, Article 120 paragraph 4 is to be amended: "Products that were lawfully placed on the market before May 26, 2020 in accordance with Directives 90/385 / EEC and 93/42 / EEC, and products that were legally placed on the market from May 26, 2020 in accordance with Paragraph 3 of the preliminary draft This article has been placed on the market can continue to be made available on the market or put into operation until May 26, 2025. "
Other MDR requirements must be met
However, the Tuttlingen network MedicalMountains points out that all other requirements of the EU MDR must be met. These include post-market surveillance, market surveillance, vigilance and the registration of economic operators. The transitional regulation is also only a kind of toleration that ends with the expiry of the respective certificate, i.e. well before May 2024. And for the processing time of files on the part of the notified bodies, at least 9 to 12 months should be allowed for. Therefore manufacturers should submit their documents as early as possible; 2023 would already be too late.
Good for companies and clinics
According to MedicalMountains, the corrigendum gives small and medium-sized medical technology companies in particular more planning security in terms of class Ir. Important existing products such as surgical instruments may continue to be sold under the previous regulatory requirements. The news not only relieved companies that saw their competitiveness or even existence threatened, it also gave hospitals a sigh of relief. Because it has long been apparent that impending product bottlenecks would have posed a threat to the secure supply of patients, says Julia Steckeler, Managing Director of MedicalMountains.
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