May 2021: European Union Medical Device Regulation (EU MDR) Update

As per the update posted on the EMA What’s New section, Regulation (EU) 2017/745 on medical devices has now become applicable in the European Union from 26 May 2021 following a four-year transition period.

The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products including medicines with an integral device, medical devices containing an ancillary medicinal substance, medical devices made from substances that are absorbed by the human body and borderline products. The Regulation entered into force in May 2017 and had a staggered transitional period.

Support materials for the implementation of the MDR, updated guidance on quality requirements for medical devices in human medicines that include a medical device as well as an updated Q&A, are currently under preparation and will be published shortly.

For more information, please click here.

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