New Regulation for Medical Devices (EU) 2017/745 MDR: General Introduction and Principles. Special requirements for Distributors and Importers

6 Hours in 2-Days

Day 1: 8:00 AM - 11:00 AM ET

Day 2: 8:00 AM - 11:00 AM ET

(3 hours each day for a total of 6 hours)

• $985.50 USD If registered 30 days prior to the start of class
• $1,095.00 USD Original Pricing

Participants will receive the below certificates at the conclusion of the course. All certificates are issued by TUV USA.

Certificate of Attendance to the attendant who participates in the entire course.

This 2-Day, 6 Hour training is to provide a general introduction and principles to Medical Devices (EU) 2017/745 MDR. With a focus on Distributors and Importers

General information:

-The concept and policy behind the Regulation

-The “Life Cycle” approach

-The status (after full implementation on 26 May 2021)

Contents:

1. General principles of the Regulation on Medical Devices (EU) 2017/745 MDR and the critical points of differentiation from MDD 93/42 / EEC.
2. New concepts and definitions,
3. Devices without a Medical Purpose subject to the requirements of the Regulation
4. New Product Classification Rules - cases of classification upgrade.
5. Importers and distributors of medical devices
6. Topics related to Product Life Cycle monitoring and Reporting (Post market Surveillance-PMS, PSUR, Summary of Safety and Clinical Performance SSCP etc.)
7. European database for medical devices (EUDAMED / SRN), UDI requirements, Implant cards, the new EMDN nomenclature etc.
8. "Legacy devices" in accordance with Article 120(3) and the transitional provisions of the Regulation.

New special requirements for the manufacturers of product systems & procedure packs and the cases where importers, distributors or other persons undertake obligations of manufacturers, relabeling/repackaging, translations etc. will also be discussed.

The attendee shall have a basic knowledge of medical device industry.

• Persons Responsible for Regulatory Compliance,
• Quality Management Officers,
• Regulatory Officers and executives of medical technology companies, as well as to any professional in the field of medical devices.

Georgios Melachrinos

TUV HELLAS (TUV NORD)

E-mail:  gmela@tuv-nord.com 

Tarsi Giannouli

Physics BSc, Biomedical Engineering, MSc, DIC

Deputy Manager PC Medical

TUV HELLAS (TUV NORD)