The Medical Device Directive will be replaced by the Medical Device Regulation (MDR 2017/745) in spring 2021. The transition period for the regulation on the European market runs from May 2017 to May 2021.
The new regulation will have a great impact on all medical device actors, throughout the lifecycle of devices, with stricter requirements on both products and on manufacturers’ Quality Management Systems.
In this you will get a basic understanding of the new requirements to help you get started on the transition project.
- 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.
The course fee includes one hour follow up session explicit to each participant for questions and discussions with one of our consultants. The follow up session must be used no later than two months after the course and is booked directly with the course leader.
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 in Swedish or in English, depending on the participants.
Printed course presentation, a printed spiral bound book of the MDR Regulation (EU) 2017/745, a short test and a certificate is included for all participants.
Emma Axelsson, Senior Quality and Regulatory Consultant
Anneli Wiedenkeller, Senior Quality and Regulatory Consultant
Dates and location
To be planned
To be planned
Our one day course divided in to two half-day sessions
To be planned
1-day course: SEK 7 650:-
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.