mdr transition

The official text of MDR extension has been published

European Commission published the official text of the proposal to extend the MDR transition period for legacy devices on 6 January 2023. The amendment has been formally adopted by both the European Parliament and the Council on 15 March 2023.On 20 March 2023,it has been published in the Official Journal and entered into force. As …

MDCG 2019-10 Article 120 Guidance

MDR Transitional Period The guidance document for the implementation of Article 120, which many companies plan to use during the transition to MDR EU 2017/745, has been published.  The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates after May 2021 can be summarised as; The guidance includes a paragraph about the surveillance …