System and Procedure Pack the RETURN with Erik Vollebregt

In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the market. Erik got some experience with the authorities that he will share with us and I have created some cases that I will propose to Erik and see how he would manage them. Erik will also talk more about IVDR as this is a topic of high importance. Erik will also tell us more about his book. Follow the links for more details.

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 companies and particularly Johnson and Johnson, he decided to create 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, podcasts, Online courses…

Links from the Video

  • Erik Vollebregt Linkedin Profile:
  • Axon Lawyers:
  • Erik’s blog:
  • Episode 119 System and procedure pack:
System and Procedure pack for EU MDR 2017/745 with Erik Vollbregt Monir El Azzouzi Easy Medical Device

One Reply to “System and Procedure Pack the RETURN with Erik Vollebregt”

  1. Nadeem


    Thanks for the great content.

    I had a question regarding procedure pack/systems:

    1. what is your take on non-integral drug device combination, for example, a medicinal substance in a bottle packed together with a CE marked syringe for administration (co-packaged drug device combination). In this scenario would the article 22 be applicable, specifically around section 1(c) where the CE marked device is combined with an ‘other product’? or would this not be applicable since the primary mode of action is the medicinal product and would need to meet the requirements of the medicinal product directive?

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