The new European regulatory landscape
– MDR and IVDR
Key2Compliance AB and Symbioteq Kvalitet AB invites you to a 1-day conference on the new MDR and IVDR
Medical devices and in vitro diagnostic devices covers a wide range of products, from sticking plasters to hip replacements and HIV tests. The new regulation will ensure that medical devices and in vitro diagnostic medical devices remain safe while allowing people with medical needs access to new and innovative treatments.
For the industry, this change impacts the process and requirements for placing devices on the market, including changes in device classification. Products in the market are affected by increased requirements on clinical evaluation and post-market surveillance and will need to apply a lifecycle approach to risk management.
This and much more will be dealt with during this intense one-day conference, see below list of issues presented:
- Most important changes; prepare for and manage the implementation.
- Roles in the regulatory system: Manufacturers, Distributors, Authorized Reps
- Responsibility & authority of Notified Bodies under the new regulation.
- Parallel sessions
- Device classification, Clinical evaluation and Conformity assessment: MDR
- Device classification, Performance evaluation and Conformity assessment: IVDR
- How to build your Technical Documentation
- Increased requirements on Postmarket Surveillance and Vigilance
- UDI implementation challenges.
- Medical device regulations and the Healthcare system
When attending a Key2Compliance® course or conference, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »
09.00 - 17.00
(Registration and Coffee 08.30-09.00)
Price (excl. local VAT):
6 340 DKK (€ 850) incl. conference notes (pdf), lunches and refreshments
Note. Due to tax/VAT regulations within the EU (for seminars/conferences/courses), the conference fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the conference fee.
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before conference start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the conference, or failure to cancel or "no-show", will be charged in full.
Cancellation of conferences:
The conference may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the conference start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another event for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled conference. If you need to book flights way ahead (+30 days prior the conference) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.