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
Έναρξη | 04-07-2022 10:00 |
Λήξη | 05-07-2022 16:00 |
Χωρητικότητα | 30 |
Τιμή ατόμου | Κατόπιν επικοινωνίας |
Διοργανωτής | TÜV HELLAS |
Τόπος διεξαγωγής | Εξ' αποστάσεως |
Πόλη | Εξ' αποστάσεως |