Essentials of European Medical Device Regulatory Affairs - October 2019

Key changes (not all)

New: • Inclusion of some new products in scope • Products utilizing non-viable cells of human origin • Products without a medical purpose • Economic operators – requirements for distributors and importers • UDI system – Unique device identifiers • EU registration system • Electronic databases • Additional centralised review processes for high risk devices • Responsible Person • Risk based classification system and certification for IVD’s Greater emphasis: • oversight of NBs • Clinical data • PMS/PMCF

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MDD vs MDR

• 35 Recitals (background, justification, scope) • 23 Articles (describes general principles, definitions) • 12 Annexes (specific requirements) • I: essential requirements • II to VII: procedures to demonstrate conformity 

• VIII: devices for special purposes • IX: definitions , classification rules • X: clinical evaluations • XI: notified bodies • XII: CE mark 

MDR  • 10 Chapters • 123 Articles • 17 Annexes Total Pages: 175

• Total pages: 60

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