Registration of reusable or upclassified Class I devices and/or expiring CE certificates

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance concerning the extension of validity for medical device certificates originally issued under the European Union Medical Device Directive (EU MDD) and Active Implantable Medical Device Directive (EU AIMDD). This regulatory adjustment follows EU legislative changes designed to prevent product shortages by allowing legacy devices to remain on the market for a longer transitional period. The guidance does not pertain to a specific company inspection or violation but serves as a framework for all manufacturers currently using these directives to access the UK market. Under this framework, manufacturers and authorized representatives must manage their registrations through the MHRA Device Online Registration System (DORS). Required actions include updating existing device records to reflect the new certificate expiry dates and ensuring that all supporting documentation remains valid under the extension criteria. Manufacturers are responsible for verifying that their devices continue to meet safety standards and that their DORS profile accurately represents the legal status of their products. Correctly navigating these administrative updates is essential for maintaining uninterrupted market access in Great Britain and Northern Ireland, as failure to align registration data with the extended certificate timelines may lead to compliance issues during market surveillance.