Committee
Regulatory Affairs
In order to place an IVD on the market in Europe, CE marking of the products is mandatory. The committee deals with all topics relating to CE marking and monitors all working groups that work with the committee. It also provides a platform for exchange between members and coordinates all statements and discussions with stakeholders.
The IVD Regulation (EU) 2017/746 (IVDR) is of central importance for all manufacturers in Europe in order to be able to offer their products under this CE marking The committee is intensively dedicated to the implementation of this regulation and deals with all relevant aspects - from clinical performance studies and conformity assessment procedures to post-market activities. The innovations from Europe are brought directly to the committee and discussed in detail. The committee's working groups report regularly on their progress and are assigned specific tasks.
The committee is also responsible for preparing statements and discussions with key stakeholders, including the German Federal Ministry of Health (BMG), notified bodies and the Medical Device Coordination Group (MDCG). In addition, the committee votes on topics that are discussed at European level at the industry association MedTech Europe. Last but not least, the committee regularly organizes seminars on the topic of IVDR.