The In Vitro Diagnostic Medical device directive has partially been replaced by the In Vitro Diagnostic Regulation. The transition period for regulation 2017/746 for IVD devices on the European market is postponed for some processes and some of the products but for other products it is required from 26th of May 2022. The new regulation will have a great impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ QMS’s, throughout the product lifecycle.
QAdvis offers a 1-day course on the new regulation, to give you a basic understanding of the new requirements and help you get started on the transition project.
- Key differences between IVDD and IVDR
- Classification rules and conformity route
- Time schedule – what is required when
- Technical documentation requirements overview
- General safety and performance requirements (GSPR)
- Post-market surveillance
- UDI and product labelling
- Performance evaluation
- Common specifications
- Impact on quality management systems
- Implementation timeline
- Implementation plan
- How to conduct a gap assessment
This course is intended for quality and regulatory professionals working with In Vitro Diagnostics, medical device company management and employees who need to learn more about the impact of the IVDR.
After the course, participants will have a basic understanding of the requirements of the new In Vitro Diagnostics Regulation (IVDR) and of its impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ quality management systems, throughout the lifecycle of a product.
Recommended prior knowledge
The course has been developed for participants who have a basic knowledge of IVDD and ISO 13485.
Course material will be in English, verbal presentation and discussions in Swedish.
Printed course presentation, a printed spiral bound book of the IVDR Regulation (EU) 2017/746 is included only in our On-site courses. Online courses provide course presentation sent by email.
A short test and a certificate are included in all our courses.
Anna-Karin Areskog, Senior Quality and Regulatory Consultant
Dates and location
09.00 – 16.00
To be decided / On request
To be decided / On request
SEK 6 900:-
All prices excl. local VAT.
For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.
Cancellations must always be communicated to Academy@qadvis.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 4–2 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended.
QAdvis reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course.
QAdvis reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.