Getting Products Registered in Europe

Access to the EU/UK/Swiss Market after the EU MDR/IVDR Implementation

The sessions will provide an overview of the “NEW CE Marking” process, according to the Medical Device Regulation. The Brexit (UK requirements) and Swixit (Switzerland requirements) outcome for medical devices will be discussed. It goes into details on specific critical subjects for the manufacturer and outlines the changes a manufacturer must consider.

The concepts are set and manufacturers who want to enter the EU Market and/or do not want to risk the CE marking for their products must evaluate the changes and additions NOW in order to prepare for a timely implementation. The transition period is short and Europe does not allow “Grandfathering”

It is important to know the new specific requirements for your products and the timelines available to make sure that your products and your company are ready for the “NEW CE Marking”.

Who will benefit?

Medical device manufacturers who market or plan to market their products in Europe.

Medical device professionals - CEO, Lawyers, Regulatory and Compliance experts, risk management – since it is crucial to fully understand the EU requirements.

 Yes, I wish to attend the conference

If you wish to give me a specific feedback : 
For full details.

Fee:RM1500.00 Per Pax (100% HRDF Claimable)


Thursday 20th April 2023


T 03-9134 5391


09:00 - 09:30 Morning Coffee
09:30 - 10:00 Welcome Address - Overview of the Program
10:00 - 12:00

New Regulations in place to enter Medical Devices in Europe (EU/UK/Switzerland
Economic Operators (Manufacturers, Authorized Representatives, Importers/Distributors) Scope & Definitions.

12.00 - 13:00 Lunch
13:00 - 15:00

Regulatory aspects for market access
Timelines for new and legacy product (no grandfathering). New hurdles to overcome.

15:00 - 15:30 Tea Break
15:30 - 16:00

What is important to those Exporting to Europe?
The manufacturer must know the responsibilities of the market chain in order to protect his products.

16:00 - 16:30 Questions and end of session


Ludger Moeller, Dipl. Ing. RWTH Aachen

  • Executive Partner Medical Device Safety Service GmbH (MDSS)
  • Founder MDSS Consulting GmbH, ITN Holding GmbH, MDSS-UK RP Ltd, MDSS CH GmbH, MDSS USA LLC and MDSS Impex GmbH
  • 1996-2000 Lead Auditor and Expert with leading Notified Body (TÜV Rheinland)
  • 1997-2000 Manager of the San Diego TUV Office
  • 1995-1996 Research & Development of Medical Devices
  • University Degree (Dipl. Engineer), Aachen University of Technology
  • Member of the European Device Coordination Group (MDCG) and the Commission Working Group on Vigilance and PMS (MDCG PMSV)
  • Founding Member and Deputy Chair of the European Association of Authorized Representatives (EAAR)
  • Founding Member of the UK Responsible Person Association (UKRPA)
  • Member of the Ethics Committee of the Medical Council (Aerztekammer) for Lower Saxony
  • Member of the Regulatory Affairs Professional Society (RAPS) USA
  • Founding Member of the RAPS Germany Chapter


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