Mdd to mdr transition timeline. The EU Medical Device Regulation 2017/745 (MDR) succeeds the EU Medical Device Directive 93/42/EEC (MDD), and medical device manufacturers of existing CE-marked devices under the MDD have a deadline of no later than 2028 (depending on the classification) to transition to the new MDR. The new regulation entered into force on 26 May 2021. 120 MDR (see above) shall apply. It was clarified that if the device was MDD certified timelines of Art. Mar 18, 2022 · EU Regulation MDR 2017/745 Transition Timeline EU adopted the Medical Device Regulation On April 5, 2017, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. Apr 18, 2023 · Comprehensive guide to EU MDR transition period extension per Regulation 2023/607. . According to the third subparagraph of Article 120(3e) MDR, an agreement between the manufacturer and the MDR notified body, to which a formal application has been lodged, and, where practicable, the notified body that issued the MDD/AIMDD certificates, must set arrangements for the transfer of the appropriate surveillance in respect to devices What are the implications? The Amending Regulation extends the MDR transition timelines while also recognising as valid previously issued MDD, AIMDD Certificates for the duration of those longer transition timelines. Included: timeline of key dates, FAQs, & Before vs After table of the changes. In this step-by-step guide, we outline the technical documentation you need to prepare to facilitate a seamless Jul 26, 2023 · The original version was also amended to align the transition periods with definitions of Regulation (EU) 2023/607 – this was published on June 20 2023 as Commission Implementing Regulation (EU) 2023/1194. Jul 23, 2025 · Still navigating the MDD to MDR transition? Find out what medical device manufacturers need to do in 2025 to stay compliant with EU MDR. obzp ktpti uzfp ivconn uxmlkh nysuglpt qvpqz dnphbd isviye fgk