Medical Device Regulation 2017/745 - Del 1
MDR Requirements for Manufacturers Part 1
The MDR is designed to ensure the safety, performance, and compliance of medical devices throughout its lifecycle, and imposes stricter requirements than previous directives.
This full-day course provides an Introduction to the Medical Device Regulation (MDR 2017/745), the EU's regulations for medical devices.
The course covers the main principles of MDR, including classification, conformity assessment, clinical evaluation, postmarket monitoring, and vigilance.
Participants can gain practical insights into how the MDR requirements can be implemented in their organizations to ensure compliance.
Course Objectives:
After the course, participants will be able to:
- Understand the key principles of MDR 2017/745 and their implications for the industry.
- Identify medical device classification rules and associated regulatory pathways.
- Explain the requirements for clinical evaluation, technical documentation and conformity assessment.
- Recognize the importance of post-market monitoring (PMS), vigilance, and reporting obligations.
- Understand the role of Notified Bodies and the certification process.
Who should attend:
The course is relevant for anyone who works with the development, production and regulation of medical devices, including:
- Regulatory specialists
- Quality Assurance Officers
- Medical Device Manufacturers and Engineers
- Clinical and compliance teams
- R&D and product development team
- Anyone working on MDR certification and compliance
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.
