Europe – With 6 months until new EU medical device rules, what’s the state of play?

The European Commission issued a second corrigendum Nov. 25 confirming manufacturers of certain lower risk medical devices will get additional time to comply with the MDR. The corrigendum gives some Class I devices — including certain reusable products like surgical instruments and endoscopes and certain software that’s been moved into a higher risk class — a four-year transitional period until May 26, 2024, before they are required to meet the new regulation’s standards.

Implementation of sweeping new rules overhauling how medical devices are regulated in the European Union is just six months away.

Industry has been arguing for more than a year that the system isn’t yet ready to handle the onslaught of devices that must be reviewed under the Medical Device Regulation, particularly when the number of notified bodies designated to certify them is much lower than the 20 that the EC expected by year’s end, with only seven available so far. The regulation is set to take effect May 2020.

« [D]espite the industry’s efforts to get ready, we remain seriously held back by the slow and piecemeal implementation of the new regulatory framework, » MedTech Europe, which represents the EU medical device industry, said in a Nov. 26 statement

The regulation is intended to increase the intensity of pre- and postmarket reviews and standardize rules for medical devices and diagnostics…