medicaldeviceslegal

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

On 16 March 2020 the Commission published the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.While this recommendation has been flagged here and there as ‘this may be important’ without real further comment I have been thinking about this recommendation myself and here is my take on what it means and may lead to. What is this recommendation about? Obviously this recommendation is an atte [...] « Read the rest of this article on medicaldeviceslegal »