Changes to medical devices in the European Union

The European Union Medical Device Directives (MDD) 93/42/EEC will transition to the Medical Device Regulation (MDR) 2017/745 on 26 May 2020.  New changes stemming from the transition establishes “economic operator” (e.g. distributor, importer) and states that each economic operator and previous operators in the distribution chain must adhere to regulations. 

Medical Devices Regulation (EU) 2017/745 will replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). Both regulations bring a series of important improvements to conformity assessment for medical devices with the intention to:

Improve the quality, safety and reliability of medical devices placed on the European market.

Strengthen transparency of information related to medical devices for consumers and practitioners.

Enhance vigilance and market surveillance of devices in use.

The regulation can be accessed here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)