European notified body TÜV SÜD said it will extend the implementation date for the MEDDEV Rev. 4 guideline on clinical evaluations for device manufacturers and notified bodies.
The Munich, Germany-headquartered group said the reference standard reflected “state-of-the-art methods of clinical evaluation,” but was not in line with the EU’s new medical device regulation published May 5.
The MEDDEV Rev. 4 standard goes significantly beyond the EU regulation, and pushing the deadline back will allow devicemakers to meet the new EU medical device regulation (MDR) and IVD regulation first and then transition to the new MEDDEV standard, TÜV SÜD said.