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Today the Medical Device Coordination Group (MDCG)* released a new Position Paper:
MDCG 2022-14: Transition to the MDR and IVDR – Notified Body capacity and availability of medical devices and IVDs
Due to concerns about disruption in the supply of devices in Europe, the MDCG was called upon to propose solutions regarding Notified Body capacity and medical device manufacturers’ MDR/IVDR readiness.
Below are some of the solutions proposed by the MDCG.
The Position Paper ends with a reminder that derogations are only granted in situations that are in the interest of public health, patient safety or patient health. And that manufacturers must be able to “demonstrate that they have undertaken all reasonable efforts to transition to the Regulations” in order to be eligible.
*The MDCG is made up of medical and industry experts, and include representatives from all of the EU member states. They aid the EU Commission, and deal with key issues, such as medical device legislation, notified body oversight and market surveillance.
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