The new European regulatory landscape
– MDR and IVDR
A 1-day conference on the new EU Regulations
In wonderful Copenhagen
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 ISO13485:2016.
Industry best practice: the invention of “Coala Heart Monitor” and their way to the market.
Introduction and welcome
The new Medical device regulations and the Healthcare system – how will the regulations influence the healthcare, regarding traceability, use of implant cards, etc. And is reprocessing inside the hospital allowed or not?
Lennart Philipson, PhD, Associate Professor. and former Scientific Director, Medical Devices, at MPA.
Challenges and opportunities for the industry - the impact of Eudamed on sharing information about safety and clinical performance and the traceability requirements
Dario Pirovani ,
Senior Regulatory Advisor, Medtech Europe
MDR from the NB perspective: Overview of the regulation, Device classification, Conformity assessment, Technical Documentation, transition plan and timelines, for general medical devices.
Scheme Manager and Technical Expert at BSI
IVDR from the NB perspective: Overview of the regulation, Device classification, Conformity assessment, performance evaluation, transition plan and timelines, for general medical devices.
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, PMS and PMCF.
Lina Burman, PhD Consultant at Symbioteq, member of TC10993
ISO13485:2016 and the new regulations– how well do they match? Class I products, and how to manage your Quality Management System -
“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
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.
Discounts: 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.