Software in Medical Devices, by MD101 Consulting

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MDCG 2022-14: Red Queen Effect

The MDCG published in August 2022 the MDCG 2022-14 position paper on Notified body capacity and availability of medical devices and IVDs.

The role of the MDCG is to tell the law, not to change the law. In the current situation, any proposition from the MDCG only scratches the surface of the problem during the transition phase. It doesn't treat the root cause.
The bottlenecks will remain after the transition phase. The root cause is a too strict classification, onboarding lots of low-risk devices in a Notify Body certification scheme.

As long as this is not changed, the MDR / IVDR will be a major obstacle to the supply of medical devices and a major impairment to innovation. This is not the role of the MDCG but the role of the Parliament to change this.

The MDCG is subject to the Red Queen effect:

It takes all the running you can do, to keep in the same place. If you want to get somewhere else, you must run at least twice as fast as that!

Alice Wonderland Red Queen Race.jpg, Aug 2022

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