Online course: Regulatory Specialist MDR – IVDR
Your career springboard to becoming a Regulatory Affairs Manager
Our current run of our online course: REGULATORY SPECIALIST EU for medical devices and in vitro diagnostics according to MDR / IVDR runs until May 22, 2026—you can start with any module at any time and complete the remaining modules in one of our next runs! The next planned start with Module 1 is in fall 2026.
With this practical and implementation-oriented training course, we offer an overall view of all relevant topics of the EU regulations for medical devices MDR and in-vitro diagnostics IVDR in a compact online course!
Together with the other participants, you will implement the necessary knowledge and work packages step by step on the way to the successful approval of your medical device or in vitro diagnostic.
In order to bring medical devices and IVDs to market, EU regulations (MDR and IVDR) provide clear but significantly expanded guidelines. If the requirements that must be met are taken into account during design and manufacture, time-consuming and costly detours on the path to market entry can be avoided.
Als Regulatory Specialist MDR / IVDR können Sie die notwendigen Arbeitspakete für die Umsetzung der MDR / IVDR definieren!
COURSE CONTENT: Regulatory Specialist MDR & IVDR
| Module 1 | Technical Documentation for Medical Devices and IVD | fall 2026 |
| Modul 2 | General Safety- and Performance Requirements for Medical Devices and IVD | fall 2026 |
| Module 3 | Requirements & processes for the development of medical devices & IVDs | 13.03.2026 |
| Module 4 | ISO 14971:2019 – Risk management for medical devices & IVDs | 20.03.2026 |
| Module 5 | Clinical testing & evaluation of medical devices and in-vitro diagnostics | 16.04.2026 |
| Optional | Person responsible for regulatory compliance (not included in the course price!) | 22.04.2026 |
| Module 6 | Labeling and UDI marking of medical devices and in-vitro diagnostics | 29.04. and 08.05.2026 |
| Module 7 | Post-market surveillance (PMS) | 22.05.2026 |
Individual modules can also be booked!
PARTICIPATION REQUIREMENTS
In order for you to benefit optimally from our online course, we recommend prior experience in the areas of development, production, sales, quality management, market launch or approval of medical devices or in-vitro diagnostics.
Costs
- Standard fee: € 3.490,00 (excl. VAT)
- Includes: Seminar documents as PDF, certificate of participation and examination fee
- Our current course runs until May 22, 2026 – you can start with any module at any time and complete the remaining modules in one of our next courses! The next scheduled start date for Module 1 is fall 2026.
- Registration: seminare@encotec.at
NEW: en.co.tec scholarship 2 x 490,- apply now!
Discounts
Get 10 % discount for:
- Cluster members (Standortagentur Tirol, Forum Medtech Pharma, Human.technology Styria, LISAvienna, MTC Oberösterreich, Innovation Salzburg, ecoplus NÖ),
- from the 2nd participant of a company / organization,
- for repeat visitors who have already attended en.co.tec seminars.
- The discounts cannot be combined
- All seminar discounts at a glance
VENUE: ONLINE
All you need for our ONLINE courses is a laptop with a camera and microphone. Our eLearning platform works on all operating systems in a web browser.
You will receive the seminar documents and the link to the virtual seminar room by email in good time. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask the lecturer your questions, there will be exercises and also the opportunity to exchange ideas with the other participants.
