• The new European regulatory landscape
    – MDR and IVDR
    A 1-day conference on the new EU Regulations
  • In wonderful Copenhagen
    Copenhagen, Denmark
    18 January 2018

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 device covers a wide range of products, from sticking plasters to hip replacements and HIV tests. The new regulations published in May 2017 aims to ensure that medical devices and in vitro diagnostic devices remains 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 already in the market are affected by increased requirements on clinical evaluation and post-market surveillance and life cycle approach to risk management.

This and much more will be dealt with during this intense one-day conference, see below list of issues presented:


  • Medical devices and the Healthcare system – integration of medical devices and information systems in patient care.
  • Challenges and opportunities for the industry; the impact of Eudamed and sharing of information on safety and performance; registration of products and economic operators and traceability requirements.
  • Key aspects of MDR when placing products on the market; device classification and conformity assessment.
  • Key aspects of IVDR when placing products on the market: device classification, performance evaluation and conformity assessment.
  • Clinical evaluation, Postmarket surveillance & PMCF; the added value of a life cycle approach.
  • Quality Management Systems; relation between the new regulations and ISO 13485:2016.
  • Industry best practice: the invention of “Coala Heart Monitor” and their way to the market.



Introduction and welcome

Åsa Runnäs,
CEO Symbioteq


The new Medical device regulations and the Healthcare system – how will the regulations influence the healthcare, regarding traceability, use of implant cards, etc. Reprocessing inside the hospital – is it allowed or not?

Lennart Philipson, PhD, Associate Professor. and former Scientific Director, Medical Devices, at MPA.


MDR from the NB perspective:  Overview of the regulation, Device classification, Conformity assessment, Technical Documentation, transition plan and timelines, general medical devices.

Anna Mirabelli,
Scheme Manager and Technical Expert at BSI


Coffee break



IVDR from the NB perspective: Overview of the regulation, Device classification, Conformity assessment, performance evaluation, transition plan and timelines, for in-vitro diagnostic devices.

Heike Möhlig-Zuttermeister
Scheme Manager & Technical Specialist IVD at BSI.





Assessment of Combination products under MDR.

J Jamieson, former Assessor at MHRA, Freelance Consultant at JCombinations AB


Clinical evaluation, Postmarket Clinical-Follow-up and Postmarket Surveillance - what is expected – and how do these processes and requirements interact?

Lina Burman, PhD, Consultant at Symbioteq and member of ISO/TC 194 (TC for ISO 10993)

Åse Ek, Consultant at Symbioteq and Business Manager Education


Coffee break



Change management – driving the MDR/IVDR project: How to get a holistic overview to assess and implement these new requirements
We’ll use real life case examples to explore the challenges - project-wise, and change-management-wise – for implementing the new regulations.

Robert Pettersson, Managing Director, Epista Life Science - Sweden


“Coala life!“ – how we took a brand new concept to the market - and prepare for the MDR.

Philip Siberg,  CEO and co-founder of Coala Life AB and
Hsintis Rydberg, Quality Assurance Manager, Coala Life AB


Plenary session and wrap-up

Moderator + speakers




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 »







Conference facts

Code no:

Medical Device
QS/GMP region:

See agenda.

Date, location and venue:

18 January 2018, Copenhagen, Denmark
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Copenhagen (800m)

1 day
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 for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.

Cancellation policy for Conferences:
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.