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Parliamentary questions
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17 December 2019
E-004441/2019
Question for written answer
to the Commission
Rule 138
Johan Van Overtveldt, Geert Bourgeois
 Subject: Implementation of the Regulation on medical devices

Regulation (EU) 2017/745 on medical devices will apply from May 2020. However, the implementation of the new rules is proving to be a real challenge.

Among other things, the lack of notified bodies is creating problems. So far, only nine bodies have been recognised, leading to huge delays in processing applications. Furthermore, the notified bodies are said only to be considering certificates from existing customers. This being so, it is virtually impossible for businesses to place new products on the European market, which is disastrous and leads to very high costs for businesses.

The establishment of the Eudamed database has also been delayed, and it is not expected to be operational until 2022. In addition, a corrigendum will apparently provide for a transitional arrangement for Class I products with or without a certificate that are already on the market.

In this context:

Does the Commission acknowledge the difficulties in implementation?

What solutions will the Commission devise to ensure that applications for new products can be processed in a cost-effective way and without delays?

The Regulation provides for an alternative plan for the exchange of information in the absence of the Eudamed database (Article 123). Will this alternative plan be activated?

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