FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

European Parliament Adopts MDR and IVD Regs Without Amendment

April 11, 2017
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The European Parliament adopted the medical device and in vitro diagnostic regulations without amendment.

The regulations will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures.

In addition, the updated rules improve traceability throughout the supply chain and set up a central database for products in the EU, which will be open to healthcare professionals, patients and the general public.

The new rules will apply three years after publication for medical devices and five years after publication for IVDs.

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