The Medical Device Directive (MDD) was replaced by the Medical Device Regulation (MDR 2017/745) in May 2021. Medical devices with a valid MDD EC Notified Body certificate may during a transition period still be placed on the market until May 2024.
The new regulation will have a great impact on all medical device actors, throughout the lifecycle of the devices, with stricter requirements on both products and on manufacturers’ Quality Management Systems.
In this course you will get a basic understanding of the new requirements to help you prioritize and succeed with the MDR transfer.
- Key differences between MDD and MDR
- Common specifications
- Classification rules and conformity routes
- Technical documentation requirements
- General safety and performance requirements (GSPR)
- Post-market surveillance
- UDI and product labelling
- Clinical evaluation and requirements on clinical data
- 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 medical devices, medical device company management and employees who need to learn more about the impact of the MDR.
After the course, participants will have a basic understanding of the requirements of the Medical Device Regulation, MDR, and have some useful tools to use in the transition from the Medical Device Directive, MDD.
Recommended prior knowledge
Participants should have a basic knowledge of the Medical Device Directive, MDD, and of ISO 13485.
Course material will be in English, verbal presentation and discussions varies between Swedish and English. The information can be found beside the course date.
Printed course presentation and a printed spiral bound book of the MDR Regulation (EU) 2017/745 is included only in our On-site courses. Online courses provide course presentation by email.
A short test and an individual certificate are included in all our courses.
Emma Axelsson, Senior Quality and Regulatory Consultant
Anneli Wiedenkeller, Senior Quality and Regulatory Consultant
Dates and location
7 and 8 December, English
08.30 – 12.30
Our one day course divided
in to two half-day sessions:
Session day one: a joint session for both EU MDR regulation and EU IVDR regulation
Session day two: divided in to two tracks, one for EU MDR and one for EU IVDR specific training
Onsite: SEK 6 900:-
Online: SEK 5 900:-
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.
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
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.
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.