How System and Procedure Pack are regulated under EU MDR?


Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But when you have to combine multiple objects, how can you then regulate that. Is there one classification for all or should you classify and register each of them. And what if all these objects are already CE marked?

So this episode will try to help you understand the legislation for these types of products described in article 22 of the EU MDR 2017/745 regulation on system and procedure pack. We will also mention the KITS that are described in the EU IVDR 2017/746 to show if there is an equivalent for in-vitro diagnostics

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

He proposes also the service of the UK Responsible Person and EU Representative. If you need any support for your Quality and Regulatory Affairs activities, don’t hesitate to contact him.


Easy Medical Device podcast Episode 119 - System and Procedure pack under EU MDR with Erik Vollebregt and Monir El Azzouzi

2 Replies to “How System and Procedure Pack are regulated under EU MDR?”

  1. Samina Naje

    Hi Monir
    Really useful information on System and procedure pack but i do have couple of question not sure if that is something you can answer.
    1) If i am putting system or procedure pack together do i need to have a technical file.
    2) I guess the system or procedure pack needs to be registered with MHRA.
    3) On the labeling am i putting my name as the manufacturer or the distributor or economic operator.
    4) Whole system or procedure pack will have UDI DI code but what if the individual component has got their own UDI DI code. Does that need to be registered on EUDAMED or only the UDI code for the full pack needs to be registered.
    5) Does the whole pack needs to have their own lot, batch number.

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