Article

The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

20 Mar 2020, Erik Vollebregt

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

Article

Surprise! Unannounced notified body audits Commission recommendation finally issued

01 Oct 2013, Erik Vollebregt While everybody in the medical devices industry is still reeling from the ENVI vote results (of which we still don’t know what they are in detail because the documents have not been…