When it comes to medical device cybersecurity guidance in the EU, the good news is that a new guidance document is available and provides some important signposting to manufacturers and other medtech economic operators, as well as to IT operators and users on how to interpret the Medical Device Regulation (MDR).
But the more regrettable news, in the view of Simmons & Simmons lawyers Annabelle Bruyndonckx and Vladimir Murovec, is that official documents issued by the European Commission’s Medical Device Coordination Group (MDCG) were inadequately reviewed before publication, at least from a basic legal standpoint, as was the case with recent EU software guidance
