The Medical Device and the In-Vitro Diagnostic Device Regulations have introduced new responsibilities
To what extent is dentristry and/or oral implantology affected by the EU regulation.? Professor Ulrich M. Gassner, Founding Director of the Research Center for Medical Device Law at the University of Augsburg answered this as follows: “Implantologists with in-office laboratories are manufacturers of custom-made products. As of 26 May 2021, for example, they must meet exactly the same requirements that apply to industrial manufacturers of mecial devices with regard to clinical evaluations (…)”
More in the spring-issue of EDI Journal.