Cromos Pharma explains new EU Medical Device Regulation

The EU Medical Device Regulation (Regulation (EU) 2017/745) came into effect on 26 May 2021, following a four-year transition period. From this date manufacturers must comply with the new regulation when bringing new medical devices to market. The legislation aims to improve the safety of medical devices in the EU.

A growing market for medical devices in the EU

Currently there are more than 500,000 types of medical devices on the market in Europe and this number is growing rapidly. Most people will have to use a medical device at one point in their lives. The new legislation repeals previous regulation from the 1990s and applies to medical device manufacturers, importers and distributors.

 Watch our short video on EU MDR:

EMA Q & A on new Medical Device Regulation

On the 22 June 2021, the EMA issued an updated Q&A about the new regulation: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf

Cromos Pharma – your trusted EU partner

As an international CRO, Cromos Pharma has wide-ranging experience in managing all aspects of trials for medical devices. Our Regulatory Affairs Team provides comprehensive services related to the registration of medicinal products and medical devices in an efficient, timely and cost-effective manner.

Email us today at bd@cromospharma.com to find out how we can support your next project.

Cromos Pharma proudly supports the Right2hope nonprofit platform, empowering patients to explore treatment options beyond traditional clinical trials. Through an intuitive, AI-supported matching algorithm, Right2hope connects patients with the most relevant expanded access, compassionate use, and right-to-try programs.