The European Commission (EC) has collaborated with the Medical Devices Coordination Groups (MDCG) to release updated guidance documents. As a member of several MDCG groups representing the European Association for Authorized Representatives (EAAR), Emergo by UL ensures timely regulatory updates in Europe.
The recent guidance addresses two critical areas: Medical Devices Regulation (MDR) transitional provisions for Annex XVI devices and the Manual on Borderline and Classification for Medical Devices.
A Q&A document has been published to clarify transitional provisions for Annex XVI devices, aligning with Regulation (EU) 2023/607 and Implementing Regulation (EU) 2023/1194. This addresses the confusion surrounding the application of Common Specifications.
Moreover, revisions have been made to the Manual on Borderline and Classification for Medical Devices and In vitro Diagnostic Medical Devices (IVDs). Importantly, it’s noted that this manual will not receive updates for the previous Medical Device Directives due to the implementation of the MDR and IVDR.
The manual provides classifications for various products, including root canal irrigation solutions, embedded temperature sensors in orthopedic devices, sclerosing foam systems, n-butyl-2-cyanoacrylate-based adhesives, and custom-made cranial implants.
Emergo by UL anticipates further guidance releases throughout 2023, ensuring ongoing compliance with dynamic European regulations.
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