1. Medtech Insight

Legal Overview Of MDR’s ‘Overly Broad And Vague Article 10a’

 
• By Amanda Maxwell

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.

Broken_Chain
Supply chain interruptions and device discontinuations need addressing in the EU • Source: Shutterstock

Taken literally, the wording of the new Article 10a of the Medical Device Regulation introduces “a massive administrative burden on all manufacturers of medical devices on the EU market.”

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