MDR - The New European Medical Device Regulation

Beschreibung

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

Autor*in

Daniel Shoukier
Daniel Shoukier is a worldwide-recognized regulatory expert for medical devices and a book author of several publications. He is Managing Director of Bellingswood Group, a consulting company for global market access and registration of medical devices and drug combination products. He is also lead auditor and medical expert for a Swiss notified body. As a lecturer for professional academies he provides his students a deep understanding into the complex world of medical device regulation. In the past, Daniel was Vice President at Novo Nordisk, heading up Regulatory Affairs for medical devices. Before this he was Global Director for regulatory affairs at Biosensors and Olympus Medical. He also worked in the past as a lead auditor at TÜV Rheinland.

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MDR Medical Device Medical Device Regulation Medizintechnik New European Medical Device Regulation Regulation Regulatory Affairs Zulassung von Medizinprodukten

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