Document paper New medtech regulations

Implementing the new IVD and Medical Devices Regulations – Transition Periods –

MedTech Europe calls on the European Commission and Member States to ensure the support for consistent interpretation and respect for the transition periods of the new In Vitro Diagnostic (IVD) Medical Device and the new Medical Device (MD) Regulations. For all the actors, like EU and non-EU hospitals, clinical laboratories, authorities and payers, and all other relevant stakeholders, there is a demonstrable need for clarity and consistent application of the various transitional arrangements foreseen within the three-year (for medical devices) and five-year (for IVDs) transition periods.

Posted on 21.11.2017

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