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/)
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