Medical Device School: What should verify your Economic Operators?
We continue on this series about Economic Operators and this time we will let you understand what they should check. What an Importer, Distributor or Authorized Representative should check before placing your product on the market.
Erik Vollebregt from Axon Lawyers will help us to interpret the regulation as many peoples are asking some questions regarding sampling checks or about the level of details to review some elements. So don’t miss this series which will provide you with all the details.
Don’t hesitate also to go to the link section to check the Agreement Templates that I created on Economic Operators. They were reviewed specifically to match the 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 has 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/
- 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/
- RAPS Focus. Economic Operators: Roles and Obligations under EU’s MDR: https://www.raps.org/news-and-articles/news-articles/2020/2/economic-operators-roles-and-obligations-under-eu
- Medtech Europe Flowchart MDR: https://www.medtecheurope.org/wp-content/uploads/2018/01/EN_MTE_MDR_Flowchart_Dec2017.pdf
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
