Back in September, the European Commission published its third revision of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The manual includes decisions and rationales for products where the classification as a medical device or the corresponding risk class respectively is not entirely clear. It is a helpful document that may provide valuable insights on how the regulatory authorities in Europe look at certain device types.
Should you be interested in the borderline manual, please don’t hesitate to let us know and we will provide you with a copy. You can also download your version under our library section.
Source: European Commission