Document paper New medtech regulations

Implementing the new IVD and Medical Devices Regulations – Early availability & capacity of notified bodies –

MedTech Europe urgently calls on the European Commission and the Member States to ensure the availability of notified bodies designated under the In Vitro Diagnostic (IVD) Medical Devices Regulation and the Medical Devices (MD) Regulation early in the transition periods.  A fully-functioning notified body system, with sufficient capacity to manage the workload under the current and future regulatory framework in a timely manner, is vital in ensuring that patients, hospitals, laboratories and healthcare systems have continued access to safe and innovative medical technologies.

Posted on 21.11.2017

Implementing the new IVD and Medical Devices Regulations - Early availability & capacity of notified bodies -

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