The 5 most relevant changes the Medical Device Regulation MDR introduces, that you must know

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
2. Category
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.