Date: 31 October 2022
Time: 15:30-17:30 CEST
Location: Virtual
Language: English
Price in Euro: € 395,- Price in Dollar: $ 388.-
Package deal:
Price in Euro: € 1399.- for 4 sessions
Price in Dollar: $ 1380.- for 4 sessions
* Team Members with different roles and responsibilities? No problem. We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.
Introduction:
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:
- Learn about the roles of Economic Operators
- Understand the requirements sufficiently to realize the impact of implementation of the EU MDR
- Understand that 'the devil is in the details'
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: