With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory documents. In this post, we will provide an overview of all regulatory updates already available since the start of the year:
EU: EUDAMED, Annex XVI, and MDCG
The Medical Devices Coordination Group (MDCG) published the final minutes of their meetings on the EUDAMED platform and Annex XVI devices, carried out the past 19 October and 7 November, respectively. Regarding EUDAMED, the final minutes follow what was published in our previous post announcing a delay in the full functionality of the platform. As such, it is confirmed that the first EUDAMED audit will start in the second quarter of 2024 and will last until the end of the year. Moreover, EUDAMED full functionality is expected to be announced in the second quarter of 2027, after which a transitional period of six months will ensue. After this period, the following modules will become mandatory:
- Actor Registration
- Market Surveillance
- Clinical Investigation/Performance Studies (CI/PS)
By the second quarter of 2029, after 18 months, the remaining two modules (Devices and Certificates) will also become mandatory.
Regarding the Annex XVI MDCG meeting, we can expect the following:
- A revision of the Q&A MDCG guidance on transitional provisions by the second quarter of 2024
- A new Q&A guidance on MDR and Common Specifications for Annex XVI devices by the fourth quarter of 2024
Furthermore, it was clarified that Annex XVI devices without an MDD certificate falling under Article 2.1. and 2.2. of Annex XVI’s Common Specifications can benefit from the transitional period.
UK: roadmap guidance
Regarding the UK, the MHRA released a roadmap guidance on the future regulatory framework for medical devices. Specifically, the roadmap focuses on the legislation already delivered between 2021 and 2023, and gives a clear indication of which regulation can be expected for this year and 2025:
Switzerland: inspection of Swiss authorized representatives, Class I manufacturers, and mandates
Finally, the Swiss competent authority has made several announcements related to their inspection of Swiss authorized representatives, Class I manufacturers in Switzerland, mandates relating to ECM Certifications and Swiss importers.
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