Medical Device School – Who are your Economic Operators?
With MDR 2017/745 and IVDR 2017/746, we discover some new Vocabulary and one of them is clearly important to consider and this is “Economic Operators”.
Monir El Azzouzi and Erik Vollebregt will help you define who are your Economic Operators and also if you are still not sure, how to identify them.
Don’t forget to download the presentations and documents provided in the link section.
Who is Erik Vollebregt?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A.
Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.
He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.
Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology.
Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
- Monir El Azzouzi LinkedIn: https://www.linkedin.com/in/melazzouzi/
- Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/
- Erik Vollebregt Presentation: https://www.slideshare.net/ErikVollebregt/managing-new-requirement-for-economic-operator-regime
- HPRA – Guide for Distributors of Medical Devices: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13
- Easy Medical Device Shop (Download Economic Operators Agreement Templates): https://easymedicaldevice.com/shop/
4 Replies to “Medical Device School – Who are your Economic Operators?”
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We make Class I, Rule 1 products similar to eyeglasses. If we do not have distributors in the EU, but only fill prescriptions from prescribers and ship directly to the prescriber who dispenses it to their patients, do we still need to have an Economic Operator contract?
I have purchased your MDR Bundle package and have just started to use it. Your podcasts have been very helpful.
Hi Henry, Thanks for your message. And thanks for the question.
If you are located in the EU, then you can send your products directly to the prescribers. There is no need for you to have a Distributor. I mean, you are the Distributor if I can say.
The Distributor is used when the manufacturer do not have too much logistic capability. So keep the good work and don’t use a distributor if you don’t need it.
But if you are outside of the EU, then it’S not a distributor that you need but an Importer and an Authorized Representative.
I hope the Bundle will help you achieve your goals. Don’t hesitate to contact me if you need support.
Thanks for your prompt reply.
We are a US company and already have CE under MDD and have an AR (MDSS, Hannover Germany). We also have UDI numbers. I don’t understand how to create/receive the Basic UDI number.
For the Basic UDI-DI you need to contact your UDI provider. This depends on how many products you have if they are under the same category.
You should check my article on https://easymedicaldevice.com/udi to see the different providers and even the format that each of them authorize.
I hope this helps.