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.

Dr. Sascha Wettmarshausen
Regulatory Affairs & Quality, Deputy Managing Director
wettmarshausen@ vdgh.de