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Much More Is Needed, Industry Says In Response To EU's 19-Point Regulatory Action Plan

 
• By Amanda Maxwell

The new EU Medical Device and IVD Regulations are reaching a critical tipping point. The 19-point plan just released is not going to cut it, medtech players fear. Is this really the lifeline needed for the medtech industry?

A closeup portrait of a Caucasian skeptical man with his hand on his chin
EU medtech sector is generally skeptical about the MDCG's Action Plan • Source: Alamy

Just days ago, the European Commission’s Medical Device Coordination Group published a position paper on the transition to the Medical Device and IVD Regulations which features 19 proposals aimed at addressing notified body capacity issues and fears surrounding the future lack of availabiltiy of some medical devices and IVDs. (Also see "MDCG Listens To Industry Over New Medtech Regulation Hurdles And Publishes 19-Point Action Plan" - Medtech Insight, 30 August, 2022.)

But while the proposals have been welcomed as a step in the right direction and with optimism in some quarters, many critics argue they are not enough.

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• By Brian Bossetta

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