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Case For EU Software Guidance Rethink Grows As Lawyers Make Their Case

 
• By Amanda Maxwell

Lawyers Vladimir Murovec and Annabelle Bruyndonckx from Simmons & Simmons explain why the European Commission’s recently published software guidance falls short of what the EU medtech industry needs. They describe it as an afterthought and lacking legal review compared to previous MDCG guidelines.

Hands

The case for a rethink of the just published EU guidance document on medical device software (MDSW) is growing.This document has been published to help with the implementation of the new medical devices regulations, the MDR and IVDR. But it is being met with criticism from various quarters. There are claims that it contains inconsistencies and evidence to suggest that some of its content is likely to cause confusion.

Vladimir Murovec and Annabelle Bruyndonckx, of law firm Simmons & Simmons, explained to Medtech Insight how their experiences in applying...

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