UK Responsible person responsibilities of the UK Medical Device Market
Currently, the UK participates in the European regulatory network for medical devices, but once the transition period is over, this participation will also end. But what will remain the same and what will change? The answers to these questions are below. All devices that comply with the applicable EU Directive will continue to be allowed until June 2023 Changes to the labeling of the affected products will not be required. Labels in English that include information from other jurisdictions will be accepted. The product can still carry a CE mark and devices that require conformity assessment by a notified body must have a valid CE certificate. On the day of departure, a UK regulatory system will be available. All the key elements that are included in the EU regulations will appear in it. MDR and IVDR will not be "active" in the UK, but both regulations will be accepted until the end of June 2023. A change in the role of notified bodies will be implemented A...