7 Feb 2022 | All the News
Theme Obligations of distributors and importers Target Audience Importers and distributors Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2018-6 MDCG 2021-13 MDCG 2021-23 MDCG 2021-26 Regulation (EU) 2019/1020 : market...
7 Feb 2022 | All the News
Theme Notification of a substantial modification of clinical investigation Target Audience Sponsor of a clinical investigation Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-8 MDCG 2021-20 The sponsor of a clinical investigation is required to...
17 Jan 2022 | All the News, Regulation
New lists of harmonised European standards under the Medical Devices (MD) and IVD Regulations have been published in the Official Journal of the European Union. There are now 14 standards harmonised under the MD Regulation and 9 standards harmonised under the IVD...
23 Dec 2021 | All the News, Regulation
The European Commission published on December 14 in the Official Journal of the EU the Implementing Regulation (EU) 2021/2226 laying down detailed rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use for medical devices...
