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Medical devices, recommendation to manufacturers

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Medical devices, recommendation to manufacturers

On 26 May 2017, Regulation (EU) 2017/745 came into force which modified the regulatory framework of the medical device system with the aim of guaranteeing a greater level of safety and health for citizens of the European Union.

Given this, in all Member States the process of adapting to community legislation is proceeding with a significant delay.

To deal with this situation which could generate a shortage of medical devices, Regulation (EU) 2023/607 was adopted in March 2023 which extended the validity period of the certificates issued on the basis of the previous Directives until 31 December at the latest 2028, provided that the manufacturer submits a formal application to a Notified Body by 26 May 2024, and that a contract relating to the conformity assessment procedures is signed between the parties by 26 September 2024. However, the adoption of Regulation (EU) 2023/607 did not produce the expected results.

In fact, the number of certifications issued in Europe (less than 4 thousand) is, more than six years after the date of entry into force of the Regulation, significantly reduced compared to the number of certifications issued on the basis of the previous Directives (around 24 thousand).

The Ministry of Health, the national competent authority for medical devices, in order to guarantee the provision of healthcare, has urged, with a note dated November 23, 2023Italian companies manufacturing medical devices to speed up the process of adapting to community legislation and not to further postpone the submission of applications for certification of medical devices, while at the same time reporting that if these were submitted in large numbers close to the deadline set for 26 May 2024 would create an excessive workload such that the Notified Bodies, in all likelihood, would not be able to provide the expected responses, nor to guarantee the signing of a contract between the parties within the expected timeframe (29 September 2024), necessary to allow the continuation of the placing on the market.

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All interested parties are therefore invited to read the aforementioned note of 23 us, and to take action without delay in accordance with its content.

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