Compliance

This brings the total number of notified bodies appointed under the IVDR to 14

As the EU seeks to refine its medtech regulations, the advantages of the global Medical Device Single Audit Program are increasingly highlighted. Industry leaders are now urging authorities to take decisive action.

The latest list includes a new EU document in the wings that addresses the designation of medtech notified bodies under the AI Act.

Recent court cases initiated by the Swiss medicines regulator against “unbalanced” media reporting on GLP-1 drugs for weight loss highlights its zero tolerance for any form of misinformation that compromises patient safety.

The new definition of what is considered an ‘AI system’ in the context of the EU’s AI Act is helpful, but there is no automatic determination for medtech, and gray areas persist.

The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.

Measures for reporting interruption of supply or discontinuation of devices in Europe were rushed into the Medical Device Regulation, a German law firm claims, leading to the need for a stricter interpretation.

The Dermanostic app is in the spotlight again as its recent action has prompted a German regional court to believe it no longer falls foul of a ruling recently made by a higher regional court.

Industry is quoting the Draghi report on EU competitiveness and its call for a clear, agile and streamlined legal framework in an attempt to get the EU to prevent overkill in the regulation of AI.

Good is not always good enough. A centralized oversight body could help EU medtech testing bodies reach their full potential and ensure consistent regulatory balance says life sciences expert lawyer, Alison Dennis.