Training

Virtual Training: MDR Economic Operator

May 18, 2020

Date: 18th and 26th of May 2020 

Time: 13.30 - 16.30 CEST time zone / 09:00- 12:00 CEST

Location: Virtual

Language:  English

Costs: € 695.-

Introduction

Regulating the European internal market is one of the core competencies of the European Union. In the famous Cassis de Dijon verdict (European Court of Justice) a couple of key elements with regard to internal market affairs, that still holds true today, were posited. Maybe the most important position to be found in the verdict (at least for the topic at hand) is that products lawfully manufactured or marketed in one Member State should in principle move freely throughout the Union. Restriction of free movement is only allowed in cases where the concerning product is a threat to mandatory requirements such as health, safety, consumer protection. As a result of this position, from the Cassis de Dijon verdict onwards Union legislation was solely aimed at the harmonization of these aforementioned “essential requirements.” Technical specifications were to be laid down in harmonized standards. The so-called New Approach was born.

Note: this training can also be provided in-house for other organizations in the supply chain involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing or provision of associated activities. The contents will be adapted to the specific role(s) of that organization.

Economic Operators

All current and upcoming Union legislation is based on this New Approach. So too is the Medical Device Regulation (MDR) which entered into force on 25 May 2017. In comparison with the Directive, this Regulation supersedes, it contains a completely new chapter on economic operators and their obligations. The term “economic operator” encompasses manufacturers, authorized representatives, importers, distributors and the persons referred to in Article 22(1) and 22(3) of the MDR. All these individual economic operator figures now have specific legal obligations they have to comply with: distributors now have to verify whether the manufacturer they distribute products for complied with its obligations, authorized representatives now have to have a written mandate in place that divides responsibilities between them and their manufacturers and so on and so forth. Manufacturers will now have to tightly control their downstream supply chain as, for example, a non-complying distributor might potentially, when caught in the act by a Competent Authority,  lead to a withdrawal or in severe cases administrative fines or sanctions.

However, most of the economic operator obligations have already been in place since the EU New Legislative Framework was adopted in 2008. So while it might be a newly included chapter in the MDR, most of the aforementioned has already been soft law since 2008 to the shock of most people. Reason enough to start implementing these changes as soon as you can.

Learning objectives

  •         To determine which role(s) your organization and/or partner-organizations have
  •         What obligations each of the Economic Operators has according to the new Legislation
  • What the key changes implemented by the MDR, are
  •         Critical Timelines
  •         Relevant Documents that need to be established
  •         About processes that need to be revised      
  •         Impact of the new requirements on up-stream and down-stream Supply-Chain

Program overview:

Key Changes implemented by the MDR

Critical Timelines

Relevant Documents

Placing on the Market & Making Available

Actors in the Supply-Chain

Definition and Responsibilities of Economic Operators

Other Actors

Changes to Activities performed by Economic Operators

Downstream Supply-Chain

Obligations of Economic Operators

Labelling and UDI

Upstream Supply-Chain


Who should attend this course?

Employees of medical device manufacturers, importers, distributors or European Representatives who are involved with regulatory aspects of the supply chain.

Trainer:

Peter Reijntjes
Post date: August 05, 2019
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