On the eve of the European Commission’s 14 June presentation to the Council of the EU’s Employment, Social Policy, Health and Consumer Affairs (EPSCO) meeting on the status of the implementation of the Medical Device Regulation, pressure grew for the commission to announce solutions to what is seen as an impending disaster for medtech product availability in the EU.
It has been widely reported that notified bodies, which assess the conformity of medical devices against the MDR, do not have sufficient capacity to review all legacy products by the...
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