After negotiations lasting more than four years, the European Parliament adopted the EU Medical Device Regulation (MDR) on 5 April 2017. The regulation is set to come into force in May 2017 and, after a three-year transitional period, will be valid in all the EU member states as of mid-2020. The more stringent requirements are intended to improve the safety of medical devices throughout Europe. In view of the large number of rules and alignments, however, the medical device sector considers the transitional period to be “inappropriate”.

The new MDR imposes a large number of additional obligations on producers. Hence, their products will have to undergo a renewed conformity assessment procedure after a regulatory lead time of approximately one year.

Amongst the changes is an extended scope – in future, products that are not used for medical purposes, such as coloured contact lenses and implants and substances used for aesthetic purposes, will be included too. In addition, stricter specifications will apply for clinical assessment and testing. At the same time, the European Database on Medical Devices (EUDAMED) is to be expanded, giving easier access to information on approved medical devices.