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