Summary
This course provides you with knowledge of regulatory affairs in relation to Drug Device Combination products. You learn how to handle the questions that arise in the development process of combination products. We also review updated EU legislation in relation to combination products (EU-MDR).
Focus is on EU and US regulations, but Chinese requirements are also touched upon.
In addition, you will gain insights into the approval of combination products containing software.
After the course, you are able to offer your colleagues regulatory strategic advice in development projects, to collect relevant and sufficient documentation, and to search for relevant regulations in this area.
Keywords
- EU Directives for medical devices and drugs
- Risk management
- Usability and Human Factor (HFE) studies
- Essential Performance Requirements (EPR)
- Connected products for drug delivery and digital health
- Quality assurance for medical devices (ISO 13485)
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Course leader & lecturers
- Pernille SkindhøjCourse leaderSenior Director, Regulatory Device
Ascendis Pharma A/S
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Is this course for you?
Sign up for this course if you already have some experience with medicine/product registration and want to learn about regulations for drug/device combination products.
What you will learn
- The basic principles of regulations on combination products in the EU (e.g. the new MDR legislation in Europe) and the US as well as insights into the Chinese rules.
- How to assess the problems that may arise during the development of a combination product.
- How to analyse and evaluate whether a combined product is covered by the regulations for medicines or medical devices.
- How to provide solid, regulatory input in development projects for combination products.
- You also get an introduction to digital combination products, both connected devices and applications.
What your company will get
- A regulatory employee who understands the basic principles of regulations on combination products in the EU, US, and China.
- A regulatory employee who can analyse and evaluate whether a combined product falls under the regulations for medicines or medical devices.
- A regulatory employee who understands the problems that may arise during the development of a combination product.
- A regulatory employee who can provide solid, regulatory input in projects where the development of combination products is in focus.
Course calendar
Day 1
- Registration and network
- Introduction to the course
- Introduction to drug/device borderlines and combination products
- Medical Device EU Legislation
- Design and development
- Product risk management for devices and combination products
- Navigating and merging risk-based approaches for combination products
- Group work
- Summary of day 1
Day 2
- Introduction to day 2
- Usability
- Drug/Device combination products in the US
- Group Work
- Software as Medical Device & Digital Therapeutics – the link to Connected Devices
- Workshop: interactive session on how to use what you have learned
- End of module 12
Day 3
The agenda for the day will be annouced laterRegistration
Registration deadline15 Nov 2023
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course, you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarise yourself with the mandatory readings before starting the course. The mandatory readings are also part of the examination syllabus.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level and experience in regulatory affairs or other equivalent qualifications. We consider all applications upon registration.
If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs.
We consider applicants on a case-by-case basis.
Examination
The online exam is usually held 4-6 weeks after the course.
Course leader
Ascendis Pharma A/S
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Want to know more or need help?
Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30
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