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...
3 Dec 2021 | All the News
Theme Obligations of persons referred to in Article 16 Target Audience Importers and distributors Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 This guide presents a series of questions and answers about the obligations of...
3 Dec 2021 | All the News
Theme Interpretation of the transitional provisions for DM certified under the Directives Target Audience Manufacturers, Notified Bodies Products concerned MD certified under the directives (IVD excluded) Documents mentioned MDR (EU) 2017/745 MDR – Article 120 Blue...
19 Oct 2021 | All the News, Regulation
In order to ensure a continuous supply of in vitro diagnostic medical devices, the European Commission proposes to extend the periods initially foreseen in the Regulation concerning the transitional provisions. Please note that this proposal does not aim to change the...
