Medical Device Regulation 2017/745 - part 2
MDR Requirements for Distributors, Importers and Procedure Packs
Under the Medical Device Regulation (MDR), all players in the supply chain have specific responsibilities to ensure that only compliant, safe, and legal medical devices reach the market.
This full-day course provides a thorough introduction to the MDR 2017/745 requirements for distributors, importers, and procedure kit assemblers of medical devices.
Note: This course can be seen as a continuation from Introduction to MDR 2017/745 Part 1 or taken on its own.
The course covers the most important obligations for distributors and importers, including requirements for traceability, documentation, market surveillance and cooperation with authorities and manufacturers. In addition, the specific requirements for procedure sets and systems under the MDR are reviewed, including responsibility for declarations of conformity, and labelling.
After the course, participants will be able to:
- Understand the requirements of MDR for distributors and importers in the medical device market.
- Identify the requirements for compliance, verification of documentation and product safety for imported and distributed products.
- Explain the role of procedure set assemblers and what requirements MDR places on systems and sets.
- Implement effective traceability and market surveillance systems to meet requirements.
- Manage nonconformities, recalls and work with authorities and manufacturers to ensure compliance.
- Understand the responsibilities of storage, transportation, and redistribution according to the MDR.
Who should attend?
The course is relevant for:
- Manufacturers to understand what requirements they should make to other players
- Medical Device Distributors
- Importers who bring medical devices into the EU/EEA market
- Companies that put together sets of procedures and systems
- Quality Assurance and Compliance Officers
- Regulatory specialists and legal advisors in MDR
- Managers and operational teams working on the medical device supply chain
Up to 30% off this summer! ☀️
There’s never been a better time to invest in your professional development. This summer, enjoy discounted rates on our courses and conferences. Bring a colleague or two and unlock bigger discounts!
- 1 participant: 10% off (code: Sommer10)
- 2 participants: 20% off (code: Sommer20)
- 3 or more participants: 30% off (code: Sommer30)
Planning to attend with others? Make sure to click “Register additional participants” in the sign-up form.
*The offer applies to registrations made from June 16 to August 11, 2025, for both regular participants and Tekna members. Note that the discount only applies to courses and conferences under Tekna.no/kampanje/kurs, except the for Tekna Leadership Development GILA program, Seabed Mapping and Inspection 2026 and Kundeservicedagene 2026. The summer discount cannot be combined with other discounts or early bird prices.
