EU medtech reg: Global and EU guidance docs still offer more sustainable way forward
This article was originally published in Clinica
Executive Summary
Is the proposed introduction of the “scrutiny procedure” a sign that EU regulators have lost faith in the wealth of EU and global guidance documents that have painstakingly been put together over the last decade? Emmett Devereux, director of quality and regulatory affairs at Cook Medical, reflects on what he considers to be an equally convincing way forward to regulate medical devices, but without the need to introduce any substantially new and potentially disruptive and economically crippling measures
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Medtech regulatory reform in the EU: Look to existing guidance documents and forget pre-market scrutiny
The European Commission's proposed introduction of a pre-market scrutiny procedure for medical devices signals that European regulators have lost faith in the wealth of EU and global guidance documents that have painstakingly been put together over the last decade. This very guidance, however, holds the key to future regulation, suggests Emmett Devereux.