Registration of in vitro diagnostic devices with expiring CE certificates

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the extension of validity for specific in vitro diagnostic (IVD) devices previously certified under the EU Directive 98/79/EC (IVDD). This announcement follows European Union legislative changes that lengthen the transition periods for certain medical devices. The guidance serves to clarify how these extensions impact the registration process within the MHRA’s Device Online Registration System (DORS). Under this regulatory framework, manufacturers must ensure their product information remains current to legally market devices in Great Britain. The primary required action for companies is to manage and update their existing registrations in the DORS portal to reflect the extended certificate timelines granted by the EU. While the document does not list specific inspection dates or company-specific violations—as it is a general administrative guidance rather than an enforcement report—it emphasizes that manufacturers are responsible for maintaining accurate documentation. Failure to align DORS records with the updated validity periods could lead to administrative non-compliance. Manufacturers are advised to review their certification status and update the registration system promptly to ensure uninterrupted market access and adherence to UK medical device regulations.