Working group: Vigilance and PMS
The Vigilance Working Group was founded in response to the significantly increased requirements for vigilance and post-market surveillance in the new IVD Regulation. The WG also serves as a platform on which members can exchange information on the specific German requirements and coordinate standardized communication with the authorities.
Objectives of the WG:
- To create a forum for exchanging views on problems that arise
- To develop common positions
- To enable a unified approach towards German authorities
- To introduce a German position into the MedTech Europe umbrella organization
- To influence EU legislation
In addition to the aforementioned focal points, the working group offers members the opportunity to exchange information on similar problems in third countries.
