Author: admin-askorn

The publication on June 29th 2016 of the guide MEDDEV 2.7/1 revision 4 relating to the clinical evaluation of medical devices reinforces the requirements to match what is required by MDD regulation 2017/745. Main changes that manufacturers need to...

The application of MDD regulation 2017/745 is not without consequences for reusable surgical instruments. While it was initally suggested to change their class to IIa, they are finally still classified as class I medical devices. However, section ...