Day 1

General Introduction – ΜDR Overview
Obligations related to Registration in EUDAMED
UDI Obligations
Technical Documentation (European Medical Device Nomenclature-EMDN, Annex II- Analytical presentation of all the requirements),
Clinical Evaluation,
New Reports (PMS, PSUR, PMCF, SSCP)
Information to be supplied by the manufacturer/Implant card
Post Market Clinical Follow up -Part A: PMCF Plan Template, MDCG 2020-7, PMCF Evaluation Report Template, MDCG 2020-8

Day 2

Article 10, Manufacturers Obligations
Article 10 vs EN ISO 13485
PMS & Relation with CEN ISO/TR 20416:2020
Post Market Clinical Follow up -Part B: IMDRF document MDCE WG/65 final:2021
Article 22, System and Procedure Packs producers
Updates to existing MDCG Guidelines
Legacy Devices-Transitional Requirements