Category: Regulatory affairs

Article 147 from French law n° 2016-41 dated January 26th 2016 relating to the modernization of the French healthcare system specifies that when a medical device is first put into service on the French national territory, the manufacturer or its aut...

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 ...