Do your Economic Operators need a Quality Management System?
We know that the Manufacturer of a Medical Device needs a Quality Management System, but what about the Importer, Distributor or Authorized Representative? Do they also need to show they have a system that guarantees that what they are distributing is correct? Erik Vollebregt from Axon Lawyers will help us understand what is written on the different texts. The answer is not easy as there is what is mandatory by EU MDR 2017/745 or EU IVDR 2017/746 and what is common sense. Can you be blamed because you don’t have an ISO 13485 certification? Don’t forget to review the other episodes related to Economic Operators to have a full view of the process.
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 from the Video
- Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
- Axon Lawyer website: https://www.axonlawyers.com/
- Bonus Episode 9 – What is the responsibility of Economic Operators: https://podcast.easymedicaldevice.com/mds9/
- HPRA Distributor Guidance: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13