MDR - The New European Medical Device Regulation

FOR WHOM IS THE MDR COMPENDIUM WRITTEN?
On 175 pages pages, the new European Medical Device Regulation (MDR 2017/745) describes in 123 articles and
17 annexes the new requirements for the registration and CE marking of medical devices in the EU, which is
replacing the medical device directives (MDD) and the directive for active implantables medical devices (AIMD).
This compendium is a quick overview of the new MDR and is intended to give the interested reader an easier
access to the complex subject matter. The MDR Compendium is predominantly designed as a question-andanswer
text and deals with the most important aspects of the medical device regulation.

HIGHLIGHTS:
Key elements of the new MDR
EU Conformity Assessment Procedures
Economics Operators
Unique Device Identification (UDI) System
The European Databank (Eudamed)
Medical Device Coordination Group (MDCG)
Liability coverage
Authorised representative
Re-classsification of certain medical devices
Scrutiny process for certain class III and Class IIb devices
Reprocessing single-use devices
Products with aesthetic or non-medical purpose
Tissues or cells of human origin
Clinical investigation
Vigilance and Post-Market Surveillance