This video clip offers an introduction on the 5 most pertinent modifications the MDR presents. These adjustments consist of
The Medical Tool Guideline MDR changes both, the Medical Tool Instruction (MDD, 93/42/EEC) as well as the Regulation for Energetic Implantable Medical Instruments (AIMDD).
1. Consistency analysis treatments
3. Crucial demands – General security as well as efficiency needs
4. UDI & EUDAMED
5. Post-Market needs
The Johner Institute aids clinical tool makers to quick as well as conveniently browse the authorization procedures, to meet the MDR demands and also to acquire the CE mark.
Free consulting on www.johner-institute.com.