European Parliament enacts new Medical Device Regulation
On May 5th, 2017, the new EU regulation on medical devices was passed by the European Parliament. It entered into force on May 25th. After a three-year transitional period, the regulation will be compulsory for every EU member state in May 2020.
The regulation determines rules for placing and launching medical devices and their accessories intended for human use on the market in the union. Equally, it applies to performed clinical tests, which relate to these medical devices and accessories.
The aim of the new regulation was to strengthen the requirements for the safety of medical devices throughout Europe and thus improve them. CMC Consumer Medical Care GmbH has carefully analyzed the new regulation and implements all necessary adjustments accordingly.