MDR TRAINING-

Person Responsible for Regulatory Compliance Course

The aim of this 2-day comprehensive course is to provide the knowledge and train attendees to be able to act as "Person Responsible for Regulatory Compliance" within their organisations under the Medical Device and In-Vitro Diagnostic Medical Device Regulations (MDR & IVDR). 

Israel, Tel Aviv

Chamber of Commerce Business College, 

HaHashmonaim Street, 84

24 - 25 February, 2020

3,800 ILS/1 person/ VAT excluded

Keynote Speakers

Doram Elkayam

WHY SHOULD YOU ATTEND?

STANDARD FEE 

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Comprehensive

Up-to-date

Relevant

Comprehend the conformity assesment paths and how they apply

Understand the MDR & IVDR essential requirements

MDR & IVDR Regulations: Key changes and implementation

Mika Reinikainen

Managing Director Abnovo Ltd.

24th - 25th  FEBRUARY 2020, ISRAEL

Seminar Schedule

Monday, 24th February 2020

General overview of the MDR

Welcome and outline of the course, its purpose and objectives

• Main articles and annexes
• Scope
• New or modified definitions
• Clinical evaluation consultation and mechanisms of scrutiny
• Summary of safety and clinical performance
• Enforcement dates, what devices need to comply on 26 May 2020? Interpretation of articles 120 and 123
• Implementing acts

Coffee

Clinical evaluation and performance evaluation:

Role and responsibilities of the Economic Operators

• Manufacturer
• Authorized Representative
• Importer, and distributor
• Registration and timelines

Person Responsible for Regulatory compliance within the manufacturer

• Qualification
• Role
• Responsibilities and liability 

Lunch

Technical Documentation MDR / IVDR, including the Declaration of Conformity  

Coffee

Conformity Assessment Procedure MDR

Tuesday, 25th February 2020

Quality Management Systems and EN ISO 13485:2016

• A walk through ISO 13485
• Main changes in the 2016 version

Risk Management, MDR/IVDR

• Risk Management standard, EN ISO 14971
• Key elements to be covered in the Risk Analysis

Coffee

Classification - MDR

• Definition of a medical device
• The classification rules
• Which MDR products require compliance by May 2020 because of classification changes 
• Reclassification of software to IIa or IIb
• Mobile apps

Classification workshop

Lunch

How to keep up with EU regulatory development and ensure compliance with related QMS requirements

Coffee

Information on the EU UDI

• Basic UDI, UDI-DI, UDI –PI, UDI Database 
• GMDN CND codes
• EUDAMED

Recap of tasks to do to comply with the Regulations

Questions and answers

Assessment of the course

Close of course

9.00 - 9.15

Doram Elkayam

Obelis s.a. - COO

9.15 - 10.00

10.00 - 10.15

10.15 - 11.15

Erik Vollebregt

Axon Lawyers

Doram Elkayam

Obelis sa, COO

11.15 - 12.00

12.00 - 13.00

13.00 - 14.30

14.30 - 14.45

14.45 - 15.45

9.00 - 10.00

Shlomi Zandberg

SYNC Projects

10.00 - 10.30

Mika Reinikainen

Abnovo Ltd.

Managing Director

10.30 - 10.45

10.45 - 11.30

13.00 - 13.45

12.00 - 13.00

13.45 - 14.30

14.30 - 14.45

14.45 - 15.30

15.30 - 15.45

Doram Elkayam

Obelis s.a. - COO

15.45 - 16.45

Dr Max D. Singh 

TUV SUD Product Service GmbH

Global Director

​

• Clinical investigation and performance studies
• Clinical evidence
• Clinical/performance evaluation plan and report
• Principal of equivalence (MDR)
• Post market clinical/performance follow up
• MEDDEV 2.7/1 Clinical evaluation: Guide for manufacturers and Notified Bodies

Helene Quie

Managing Director

Qmed Consulting

Dr Max D. Singh 

TUV SUD Product Service GmbH

Global Director

​

Information provided with the device, MDR (Annex I, Chapter III):

15.45 - 16.30

• Labelling and IFU requirements
• Language requirements
• Symbols
• Electronic labelling
• Labels and IFU on Website
• Content of technical documentation

Erik Vollebregt

Axon Lawyers

Post Marketing Surveillance including vigilance and market surveillance

16.30 - 17.15

Mika Reinikainen

Managing Director Abnovo Ltd

Borderline products, drugs device combination, devices containing animal derived material

Mika Reinikainen

Abnovo Ltd.

Managing Director

Mika Reinikainen

Abnovo Ltd.

Managing Director

Doram Elkayam

Obelis sa COO

Laure Pontis

GS1, Assistant Manager Public Policy Helathcare

Doram Elkayam

Obelis s.a. - COO

Helene Quie

Managing Director Qmed Consulting

Erik Vollebregt

         Partner           Axon Lawyers

Shlomi Zandberg

General Director SYNC Projects

Global Director TUV SUD 

             COO                 Obelis Group 

Max Singh