Medical Device School – Who controls your Economic Operators?
In this Medical Device School Bonus episode, Erik Vollebregt and Monir El Azzouzi are helping you to understand the way the Economic Operators are controlled.
A Manufacturer can be controlled for example by a Notified Body. But what about a Distributor, Importer or Authorized Representative? You’ll know everything about it in less than 10 minutes.
Economic Operators need to create agreements between them to be sure that they are working in collaboration. Check the templates provided in the shop. They were updated to meet the EU MDR and IVDR requirements.
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…
- 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/