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EMA Issues Guidance Related to New European Medical Device, IVD Regulations

NEW YORK (360Dx) — The European Medicines Agency this week published its first guidance to help test makers bring their products into compliance with new regulations.

The guidance is the first of several that will cover the new medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), which are set to come into force by 2020 and 2022, respectively.

The European Commission adopted new directives covering medical devices and IVDs in 2017, but provided test makers with several years to achieve regulatory clearance for their products under the new regulations.

Presented in a Q&A format, the guidance published this week addresses only the MDR. It  walks applicants through the process of seeking the approval of notified bodies, organizations designated by EU countries to assess certain products, in order to achieve regulatory clearance for their devices. The agency said it will publish further updates to the guidance that will covering requirements for IVDs.

The EMA, headquartered in London, is the EU agency that has been tasked with evaluating medical devices and IVDs under the new regulations. Guido Rasi, executive director of the EMA, said in a statement that given the increasing pace of innovation and blurring of traditional boundaries between medicines and devices, it was "inevitable for the agency to assume new responsibilities in regulating complex medicines with a medical device component."