MDCG Throws Ball Back Firmly In Manufacturers' Court As Pressure Grows For MDR Solutions

EU manufacturers who delay applying to notified bodies for conformity assessment of their medtech products well in advance are being held accountable for implementation problems with the EU Medical Device Regulation.

Too late
Manufacturers must submit notified body applications at least a year before certificates expire

Regulators are holding EU manufacturers who delay applying to notified bodies for conformity assessment of their medtech products well in advance accountable for implementation problems with the EU Medical Device Regulation.

Manufacturers should not expect anyone to rescue their products if they become non-compliant as of May 2024 through their own shortcomings. If companies cannot prove they have done the preparation...

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