In brief

On 23 November 2023, the Ministry of Health urged medical device manufacturers to speed up the process of alignment with EU Regulation 2017/745 (MDR).

Key takeaways

The Ministry of Health pointed out that, although six years have passed since the new regulations came into force, the number of certificates issued under the MDR is small compared to the number of certificates issued under the previous Directives. In addition, the Ministry of Health recalled that EU Regulation 2023/607 extended the period of validity of certificates issued under the former Directives until 21 December 2028, provided that the manufacturer submits a formal application to one of the Notified Bodies by 26 May 2024, and signs a contract with them regarding conformity assessment procedures by 26 September 2024.

In order to prevent possible shortages of medical devices on the market, the Ministry of Health has therefore urged medical device manufacturers not to further delay the submission of certification applications, also pointing out that, should these be submitted in large numbers close to the deadline (26 May 2024), this would create an excessive workload for the Notified Bodies that would not be able to provide the expected responses, let alone guarantee the signing of a contract between the parties within the set timeframe (29 September 2024), which is necessary to allow the continuation of placing on the market.