The Great Misunderstanding
Monir El Azzouzi
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
Medical Device News - June 2023 Regulatory Update
Last week we had the monthly episode on Regulatory updates. If you missed it you should definitely look for any changes that may affect your company. You should always stay up-to-date so this routine of listening to this episode would help you a lot.
Check the Show Notes with all the links that will help you find out the sources of information. LINK
The great misunderstanding of the EU MDR amendment
Since March 2023 an extension for EU MDR and IVDR was voted on by the EU Commission. This podcast episode will remind you of the latest news and also answer some frequently asked questions from people. As you may see in the title there are some great misunderstandings, and the objective of today is to clear that out.??
For that, I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on the EU MDR extension.?
Who is Florian Tolkmitt??
Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs, and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance, and risk management and he is also an assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, which works on an open-source data model for Technical Documentation.??
Links to the episode
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Do you need an Importer?
If you are located outside of EU, there is a rule that you need an authorized representative to be able to sell your product in the EU but you also need an importer. This rule is also true for Switzerland and the UK.
With the EU MDR the rules for Importers are more stringent. Now importers should verify:
Then after that the other thing is to have the identification of the importer in the label too.
There is more work to do for importers. And the actual importers that are focused on logistic are not really willing to spend time on regulatory activities.
To help you then you can appoint Easy Medical Device as your importer and we will perform all the regulatory activities for EU MDR. We will even provide you with an attestation of release to prove that your product has been cleared.
Contact us to get a meeting so we can discuss your project. Even if you want help for Switzerland we can also provide this service. LINK
Medical Devices Expert with long track record in Regulatory, Quality Management and Development for CE and FDA certifications -I- Msc Biomedical Engineering, University of Münster, Germany, BA Mechatronic THU Ulm
1 年Very Valuable Input , how helpful with practical examples this Input from Florian is , The Video is so informative that you need to stop it and hear it again in some moments ,it focused direct on real deadlines and the parallel situation with NBs , administrative work load , and every important milestone as challenge that should not get lost. If we think alone the review needed time, the capacities of Nbs the amount of products and the priority which follow nbs under pressure we know from now how difficult the implementation of eu amendment would be. we understand here practically in a correct ton and very precise art not only the misunderstanding but also the time pressure which realistically would have strict consequences to manufacturers. In this qualitative art should be communicated in one way to the Eu Commission to update later the Amendments in case of Engp?ssen/ Bottlenecks!