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Mar 04
Blue Syringe

New Q&A Document Published by the EMA to Assist Medical Device Manufacturers

The field of Medical Device use is constantly evolving, with impending updates to current EU Medical Device Legislation due to take effect as of 25 May 2020. This will replace the existing Regulation (EU) 2017/745 on Medical Devices (MDR). Furthermore, the existing legislation surrounding in vitro diagnostic Medical Devices (Regulation (EU) 2017/746) is also due to be replaced by a new directive as of May 2022.

In response to this, the European Medicines Agency (EMA) will be publishing a series of guidance documents, for Marketing Authorisation Holders (MAHs) that intend to market their Medical Devices within the European Union under the new regulations.

Guido Rasi, Executive Director of the EMA, has responded “With the ever-increasing pace of innovation and the blurring of traditional boundaries between medicines and devices, it is inevitable for the Agency to assume new responsibilities in regulating complex medicines with a medical device component. The big challenge we face is to ensure we have the appropriate expertise and resources to adequately carry out these new tasks.”

The EMA, in collaboration with the European Commission (EC) and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), have published their first instalment to this series of guidance documents: a Questions & Answers PDF which provides assistance on the new rules surrounding certain Medical Devices. The Agency will continue to update this document with specific information relating to particular products (including “borderline products” which may not be clearly categorised as Medical Devices).

For more information on the new Medical Device legislation and how the EMA will be assisting EU National Competent Authorities (NCAs) with the transition, please visit their website.

*Source: European Medicines Agency’s Website

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