Article 97 – Expiring medical device certificates (Temporary application of Article 97 MDR)
The Medical Devices Coordination Group’s (MDCG) position paper on the temporary application of Article 97 MDR of the MDR addresses a specific issue facing the medical device industry: how to handle devices that are not compliant with the MDR due to expired certificates from previous directives. The paper aims to provide a uniform approach to the application of Article 97 in these situations and to prevent disruptions in the supply of necessary medical devices to healthcare systems and patients.
It’s worth noting that this document does not address the anticipated issue of a high volume of expiring certificates by May 26, 2024. Instead, it focuses on how Competent Authorities (CAs) can apply Article 97 in a legally sound, consistent, and coherent manner to deal with devices that fall under Article 120(3) of the MDR and have expired or expiring MDD or AIMDD certificates before MDR certificates can be obtained.
If you’re interested in reading the MDCG’s position paper for yourself, you can find it on the official MDCG website at https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en.
For more news and updates from the medical device industry, be sure to check out https://mdss.com/blog/