The EU’s incoming Medical Device Regulation (MDR) has created a pressing need for manufacturers to revisit and revise their technical documentation to ensure compliance by the deadline.

The race is on for medical device companies to ensure compliance with the EU’s Medical Device Regulation (MDR). With existing devices requiring re-certification by the looming deadline, there is a real danger of noncompliant medical devices being withdrawn from the market.

With less than 18 months to go until the EU’s Medical Device Regulation (MDR) becomes mandatory for any medical device on the European market, how can manufacturers ensure their products are compliant?