The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-bin...
COVID-19 info!
European Commission Comments for Consideration on COVID-19 info on In Vitro Diagnostic Tests and Their Performance Commission Working Document –...
MDR Delay!
2020.04.24 In writing and set in stone with the publication on the Official Journal of the European Union. Here is the publication. 2020.04.20 On Frid...
European Parliament votes in favor for MDR 1 year delay!
On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with 693 votes in favor, 1 against a...