Italy: MDR Certifications - Recommendations for medical device manufacturers

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).


Contents

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.


Copyright © 2025 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.