• The new European regulatory landscape
    – implementation of the MDR
    A 2-day conference on the new EU Medical Device Regulation
  • In wonderful Copenhagen
    Copenhagen, Denmark
    8-9 December 2016

The new European regulatory landscape
– implementation of the MDR
(Medical Device Regulation)

Key2Compliance AB and Symbioteq Kvalitet AB invites you to a 2-day conference on the new MDR

Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests. The new regulation will make sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.

For the industry this means a strengthening of the rules on placing devices on the market and tightening surveillance once they are available. As a consequence the ruling for independent bodies for assessing medical devices before placed on the market are tighten further, and the surveillance of these notified bodies by national authorities are strengthen.

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


  • Going from Directive to Regulation – what does it mean?
  • Change of scope; new definition and classification of Medical Devices
  • Responsibility & authority of Notified Bodies under the new regulation.
  • Changes in approval process and new “state-of the-art” for Technical File.
  • Increased requirements on Postmarket Surveillance and Vigilance
  • Roles in the regulatory system -Manufacturer’s, distributors, Authorized Repr, etc.
  • Clinical Evaluation – what is new?
  • UDI implementation challenges.
  • Relation to ISO 13485:2016

Detailed agenda (Final - 4 Dec)
Download agenda with schedule (PDF) »

Day 1 - General
  • Opening speech ”The new European regulatory landscape”.
    Eric Klasen, Medtronic AB, Sweden
    • What did the commission want to achieve and will this change meet their intention?
      What is the impact for the industry, and for the healthcare?
  • Implementation of MDR – a NB's perspective.
    Suzanne Halliday, BSI, UK
    • Main changes with respect to the product approval process. Impact on TechFile.
    • How is the relationship between a NB and a MF affected?
    • Transition periods and due date for existing/ new products.
  • Clinical Investigations – increased requirements coming in MDR.
    Åsa Andersson, Devicia AB, Sweden
    • Objectives and requirements for the CER. PMCFU. When is a Clinical Investigation required?
    • Requirements on Scientific validity of data. Rational for ”Equivalence”.
  • ”How to prepare for the MDR, a company perspective”
    Peter Löwendahl, Elekta AB, Sweden
  • What does MDR say about Stand-alone Software? Classification of MD-SW.
    Mats Ohlson, MT Advisor, Sweden
  • Summary and Panel discussion
Day 2 - Specifics
  • UDI (Unique Device Identifyer) – the requirements for the medical device industry, potential benefits and how to implement it.
    Jesper Kervin Franke, GS1, Denmark and Simon Sjöhage, Symbioteq Kvalitet AB
  • How to get to the market – and stay there! The most important changes with respect to Postmarket Surveillance.
    Suzanne Halliday, BSI, UK
  • IVDR – how will it work? Brief overiew of expected changes.
    Katalin Holenyi, Symbioteq Kvalitet AB, Sweden
  • Combination products – how to manage the quality system, US & EU approach.
    Anna Lundén, Key2Compliance AB, Sweden
  • Relation between MDR and ISO 13485:2016, and MDR versus QSR.
    Eva Wiksell, Symbioteq Kvalitet AB, Sweden
  • Prepare now! - Things to consider when introducing new regulations into your quality system.
    Antonia Claasz, Symbioteq Kvalitet AB, Sweden
  • Summary and open questions, closing remarks.



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Conference facts

Code no:

Medical Device
QS/GMP region:

See detailed agenda.

Date, location and venue:
No planned occation.

2 days
Day 1: 10.00 - 17.00
(Registration and Coffee 09.30-10.00)
Day 2: 08.30 - 15.30

Download agenda (PDF) »

Price (excl. local VAT):
6 450 DKK (€ 865) 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.

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.