January 15, 2019 - January 15, 2019
Date: 15 January 2019
Price: Regular: € 875.-
The New Approach
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.
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.
- 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
- Exercise 1
- Changes to Activities performed by Economic Operators
- Downstream Supply-Chain
- Obligations of Economic Operators
- Exercise 2
- Labelling and UDI
- Upstream Supply-Chain
- Exercise 3
- Summary and Discussion