Filter by Keywords Search Clear filters Medical Devices - Sector - Latest updates (148) RSS Showing results 120 to 140 News announcement16 April 2021Guidance on standardisation for medical devices1 min readNews announcement9 April 2021Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/7461 min readNews announcement9 April 2021Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/7461 min readNews announcement1 April 2021The expert panels in the field of medical devices now accept submissions from notified bodies for the Clinical Evaluation Consultation Procedure1 min readNews announcement23 March 2021Infographic - Is your software a Medical Device?1 min readNews announcement15 March 2021Questions and Answers on Custom-Made Devices1 min readNews announcement15 March 2021Guidance on state of the art of COVID-19 rapid antibody tests1 min readNews announcement26 February 2021Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional1 min readNews announcement24 February 2021COVID-19 tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-191 min readNews announcement18 January 2021Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities1 min readNews announcement11 January 2021Covid-19: Commission Notice on audits to be performed by notified bodies1 min readNews announcement18 December 2020Updated - Ongoing guidance development within MDCG Subgroups1 min readNews announcement15 December 2020MDCG 2020-18 - MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers1 min readNews announcement2 December 2020MDCG 2020-17 - Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 1 min readNews announcement1 December 2020The EUDAMED Actor module is in production. On 1st December 2020 the European Commission has made available the Actor registration module to Member States and economic ope1 min readNews announcement13 November 2020Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/7461 min readNews announcement20 October 2020New web page with the basic information on the EUDAMED Actor registration module1 min readNews announcement6 October 2020EU device specific vigilance guidance on insulin infusion pumps and integrated meter systems1 min readNews announcement20 August 2020Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of t1 min readNews announcement18 August 2020MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States1 min read Previous1...567Page 78Next
News announcement9 April 2021Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/7461 min read
News announcement9 April 2021Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/7461 min read
News announcement1 April 2021The expert panels in the field of medical devices now accept submissions from notified bodies for the Clinical Evaluation Consultation Procedure1 min read
News announcement15 March 2021Guidance on state of the art of COVID-19 rapid antibody tests1 min read
News announcement26 February 2021Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional1 min read
News announcement24 February 2021COVID-19 tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-191 min read
News announcement18 January 2021Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities1 min read
News announcement11 January 2021Covid-19: Commission Notice on audits to be performed by notified bodies1 min read
News announcement18 December 2020Updated - Ongoing guidance development within MDCG Subgroups1 min read
News announcement15 December 2020MDCG 2020-18 - MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers1 min read
News announcement2 December 2020MDCG 2020-17 - Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 1 min read
News announcement1 December 2020The EUDAMED Actor module is in production. On 1st December 2020 the European Commission has made available the Actor registration module to Member States and economic ope1 min read
News announcement13 November 2020Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/7461 min read
News announcement20 October 2020New web page with the basic information on the EUDAMED Actor registration module1 min read
News announcement6 October 2020EU device specific vigilance guidance on insulin infusion pumps and integrated meter systems1 min read
News announcement20 August 2020Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of t1 min read
News announcement18 August 2020MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States1 min read