New regulations for medical devices and in-vitro diagnostic medical devices have come into force

Ascensionato R. Carnà
Managing Partner

Domenico Santoro
Senior Compliance Specialist

Anna Iaria
Compliance Specialist

Studio Carnà
Milan – Rome – London Barcelona – Lugano

Objective: improve medical device safety, reliability and quality


The Medical Devices Regulation EU 2017/745 and the In Vitro Diagnostic Regulation EU 2017/746 were published in the Official Journal of the European Union on May 5, 2017.

Amongst the many novelties they introduce, the new Regulations are designed to improve the quality, safety, and reliability of medical devices and in vitro diagnostics.

With this aim, the regulations introduce a mechanism for scrutiny of certain high-risk medical devices (e.g. orthopedic prostheses, implants, insulin pumps, etc.), which will be required to undergo additional checking by expert panels appointed by the European Commission or other competent authorities before such medical devices reach the market.

These experts will play a fundamental role, since they will provide expertise and support to the Notified Bodies, the manufacturers and the Competent Authorities on the clinical aspects of medical devices.

In-vitro diagnostic medical devices will have to be categorised in classes A to D (1) according to uses the medical device is designed for and to risks associated to such uses.