Is it possible to Private Label a Medical Device under MDR & IVDR?

If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or Private Labeller, or Virtual Manufacturer.

In this episode, we will discuss this business model and what are the options for you as this is not really possible under EU MDR 2017/745 or EU IVDR 2017/746. Erik Vollebregt will provide some information on some cases where OBL is involved and also explain your choices, like importer or distributor…

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, focusing on contracts, regulatory litigation against competent authorities, and M & 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 specializing in Quality and Regulatory Affairs. After working for many years with a big Healthcare company, particularly Johnson and Johnson, he decided to create to help people better understand the Medical Device Regulations worldwide.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…


  • Erik Vollebregt Linkedin Profile:
  • Axon Lawyers:
  • Erik’s blog:
OEM OBL EU MDR 2017/745 IVDR 2017/746 Monir El Azzouzi Easy Medical Device - Erik Vollebregt Axon lawyers

3 Replies to “Is it possible to Private Label a Medical Device under MDR & IVDR?”

  1. Alistair Mayoh

    we are a manufacturer, think of selling our IP (technical file) as part of a virtual manufacturing package for companies who want to virtual manufacture but don’t have the resources to put together their own technical file.
    how much information can be redacted without it becoming a MDD redacted technical file?

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