Category: Regulatory affairs

On May 9, 2017, the European Association for Medical Devices of Notified Bodies Team-NB published the results of its yearly survey run among its 21 members, in order to collect data on certificate emission and analyse the variation with previous yea...

On June 21, 2017, the Dutch minister of health signed an agreement with healthcare profesionnals and manufacturers in order to introduce an identification system for medical devices. It was agreed to adopt the FDA's UDI (Unique Device Identificat...

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 ...