#MDR – Transition periods and definitions
- October 22, 2018
- Posted by: confinis
- Category: Regulations
Transitions periods and definitions regarding the European #MDR 2017/745.
We continue the series of providing you with some thoughts relevant when looking at how to work with the European MDR 2017/745 and touch upon the “Transition Periods”.
All clear? To date, a lot has been clarified and our common understanding is shown in the slides for you to download.
Even though the dates are defined, the biggest question mark might still be the availability of the EUDAMED. The manufacturers do have an obligation to provide certain information to the database. What happens if the database is not available in time? Well, this is under discussion and more and more voices can be heard, that it is almost impossible to anticipate that the EUDAMED will be up and running in time; but as well when this is going to happen in the end.
The presentation does not concentrate on this question and the topic EUDAMED will be addressed at a later point in time in our series again, when we intend to provide more details around the requirements and actions to be performed by the parties.
Take the presentation as a short and concise overview of Article 123.
While the pure dates seem rather straight forward and not very exciting information, the real discussion starts with how to define your strategy in working with the transition periods to facilitate the transition to MDR in your company in a way to make use of the available possibilities – does “soft transition” and “grace period” ring a bell?
How to take advantage of and use the transition periods to the company’s benefit is a discussion each manufacturer has to take individually. There is no “one size fits all”, as we are sure you have heard many times before. We additionally want to reinforce another already often placed message: If you did not do so already, do not wait any longer to take this discussion for developing your strategy for MDR implementation in order to find a smooth way and avoid costs and obstacles incurred by having delayed the process. This is valid for all classes of Medical Devices.
There are 71 definitions in Article 2 of the European MDR. Which are new? The presentation for you to download does give you the answer. Additionally, it shows references to relevant Articles and Annexes in the MDR and different MEDDEV guidance documents. This said, we all know that it is not clear yet what happens to the MEDDEV guidance documents, but we all anticipate that the content of the latest versions has reasonable relevance for the European MDR as well.
Besides new definitions, we also identified two definitions not present in the new regulation any longer. While it is clear, why the term “in vitro diagnostic medical device” is not explained any longer, the negligence of defining the term “category of devices” leaves a question mark.
Finally, there are also some changed definitions, for which the presentation gives you an overview.
Common understanding of the definitions is not a given but the base for the understanding of the rest of the regulation.
We welcome your thoughts and feedback and encourage you to get involved in our discussions. It is the time for us Regulatory Affairs Professionals to shape our common understanding by reflecting our positions – firstname.lastname@example.org
Next in this series, expect to read about the classification of medical devices under the European MDR.
To see previous blog-posts related to #MDR implementation go to www.confinis.com/blog
*partners to confinis ag: Frikart Engineering GmbH, MED-RAS GmbH, Bernd Juhre