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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

Description

10.10. - 11.10.2022 |

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10.10

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: 10 - 11  of October, 2022

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 

This also takes place in

Δευ. 10.10— Τρι. 11.10.2022

Webinar

Webinar

Location

e-learning

Price or participation fee

600€ per day

TÜV HELLAS

Λ. Μεσογείων 282
155 62 Χολαργός, Ελλάδα

+30 215 215 7455
Fax : +30 210 6528025

training@tuvhellas.gr