Why does an Importer/Distributor need to appoint a Notified Body?

Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR.

This provided some surprises. So now in certain circumstances, some importers or distributors will need a Notified Body for their products.

Erik Vollebregt from Axon Lawyers will explain to us those cases and why this is important that importers and distributors are becoming on the scope of the authorities. If you have more questions on the topic, please send us a message as there are maybe some situations we didn’t discuss in this episode.

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 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, podcasts, Online courses…


  • Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
  • Axon Lawyers: https://www.axonlawyers.com/
  • Erik’s blog: https://www.axonlawyers.com/author/erikvollebregt/?archive
  • MDCG 2021-23 – Article 16(4) https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-23_en.pdf
Podcast episode 147 - Article 16 EU MDR Monir El Azzouzi and Erik Vollebregt - Easy Medical Device

3 Replies to “Why does an Importer/Distributor need to appoint a Notified Body?”

  1. Mahmood

    1. Does MDR require ROHS and REACH compliance for class II and Class III devices.
    2. How can I get a copy of the regulation including the articles and annexures.


    • Monir El Azzouzi

      Hi Mahmood, no MDR is not requiring that but EU requires it. So if you are on scope of REACH or ROHS then you should comply to it.
      For MDR you just write MDR 2017/745 on google and take the EUROPA link

  2. Shannon

    Hi I am an Australian Manufacturer and I am having trouble getting a SRN, is there a step by step way to do this as i am struggling!
    Thank you.

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