New Regulation for Medical Devices (EU) 2017/745 MDR: General Introduction and Principles. Requirements for Manufacturers, Technical Documentation, Special Issues and Reports

New Regulation for Medical Devices (EU) 2017/745 MDR: General Introduction and Principles. Requirements for Manufacturers, Technical Documentation, Special Issues and Reports

TÜV NORD CERT GmbH in cooperation with ΤÜV HELLAS are organizing the training course

Code: 09.09.6379

Dates of conduct: 17 - 18  of January, 2023

Price or participation fee: 600€ per day

Please complete the application form on the right side of the page and send it to training@tuvhellas.gr

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

The webinar will be conducted in English.

Tutors:

Giannouli Tarsi, Melachrinos Georgios