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 Medical Device Regulation MDR? To keep you up to date please read the article on “Changes for the dental practice” below, which is published in the EDI Journal 2/2021. Thereto the BDIZ EDI conformity declaration and PRRC can also be downloaded used for all European dental practices. For the post-market surveillance, we have added the form to deal with the vigilance system (see also EDI Journal 4/2021).
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 medical devices with regard to clinical evaluations.
Post-market surveillance – vigilance system
Person responsible for regulatory compliance (PRRC)
Transitional period runs out
CED position on MDR
Interview with Professor Gassner in 2019