A decisive month for EU medical devices begins: Wednesday 26 May 2021 is MDR Day, when the new Regulation (EU) 2017/745 on medical devices becomes fully applicable, replacing the old Directives 90/385 / EEC and 93/42 / WHAT.
Since the adoption and entry into force of the new EU legislation on medical devices in April-May 2017, the Commission and all sectoral parties - national competent authorities, conformity assessment bodies, manufacturers and other economic operators, health professionals and healthcare institutions, patients and users - work together to ensure the best transition and efficient implementation. Significant results have been obtained in terms of implementing acts, guidance documents and publications / data sheets, notified bodies, dialogue and governance, information and communication, etc. - as reflected in the Commission's evolving website on medical devices.
May 2021 is also very important for the standardization of medical devices. By Saturday, 15 May, the relevant European standardization organizations, CEN and Cenelec, must decide on the acceptance of the MDR / IVDR standardization application (M / 575) adopted by the European Commission on 14 April. A desirable positive result will open a new cycle of periodicals in the Official Journal of the European Union (OJEU) of references of harmonized European standards that give the presumption of conformity with the requirements of the new regulations, thus providing a very useful and convenient way for manufacturers to comply with legal requirements when placing devices on the EU market.

More details here: https://ec.europa.eu/health/md_newregulations/overview