Medilink East Midlands and West Midlands, together with MasterControl, and their partner UL LLC, are pleased to offer a Midlands Engine Masterclass which will focus on the proposed changes to the Medical Device Regulation for the European Market. These changes are due to come into effect in late 2019 or early 2020, detailing how they will impact all medical device manufacturers.
MasterControl is a global provider of quality management software and services and UL LLC is a global independent health sciences company.
The masterclass will give delegates the opportunity to hear MasterControl & UL discuss the requirements within the regulation, particularly concentrating on:
- CE Mark transition periods
- Heightened post market surveillance
- Vigilance activities expected
- How notified bodies will be required to act going forward
This will undoubtedly have an impact on the number of notified bodies left to cover the needs, and costs will invariable rise.
MasterControl & UL will also examine the new products brought within scope of the Regulation that have previously not had a medical purpose, and how this might impact manufacturers not previously under the MDR requirements.
To register your place at this event, please click here.