Device Manufacturers Pressed by Europe’s MDCG to Get Certified ASAP

In a strongly worded position paper, the European Commission’s Medical Device Coordination Group (MDCG) has directed device manufacturers to get certified ASAP under the new device and diagnostics regulations.

In its Nov. 29 paper, the MDCG — an advisory group made up of representatives of the European Union’s member states — also pressed notified bodies across Europe to streamline the certification process, adding more transparency, predictability and consistency.

The group said that currently in excess of 24,000 medical devices under old regulations (the Medical Device Directive, or MDD) still need to be transitioned to MDR. Manufacturers have submitted 13,000 devices for certification to MDR but notified bodies have handed out only 3,900 certificates through June 2023, said the MDCG.

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