Getting Products Registered in the European Union

Access to the EU Market after May 2020 once the EU MDR takes effect

 

The sessions will provide an overview of the 'NEW CE MARKING' process, according to the Medical Device Regulations. 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 wish to export to 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 excuses or dispensations.

It is important to know the new specific requirements for your products and the time lines available to make sure that your products and your company are ready for the 'NEW CE Marketing.'

Who will benefit:

# Medical Device Manufacturers who export or plan to market their products in the EU.

# Medical Device Professionals - CEOs, Legal, Regulatory & 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.
 

Total Cost RM1000.- per Delegate.

 Tuesday 10th April 2019

09:30 Welcome address - Introduction of the Speakers
09:40 Overview of the entire programme by Ludger Moeller
10:00 Start session Ludger Moeller
10:00 – 11:20

New Regulations in place to enter Medical Devices in Europe The member states must apply the new Regulations directly without transposing them into their national law. The issues and the purpose will be discussed.

Economic Operators (Manufacturer, Authorized Representative, Importer and Distributors) Scope and definitions


Tea Break
11:30 – 12:00

What is Important to those Exporting to the EU?

The manufacturer must know the responsibilities of the market chain in order to protect his products.

12:00 Exporting to EU - The Cross Cultural Considerations (I) – Søren Askegaard, Phd

Lunch
13:00 – 14:50

Regulatory aspects for market access

Timelines for new and legacy product (absolutely no dispensations). New hurdles to overcome.

14:50 Tea Break
15:00 Exporting to EU - The Cross Cultural Considerations (II) – Søren Askegaard, Phd
15:30 Questions / Arrange one-to-one meetings for Thursday 11th April.

 

MR. LUDGER MOELLER

  • President of Medical Device Safety Service GmbH (MDSS)
  • Chairman of MDSS Consulting & ITN Holding GmbH
  • Member of the European Commission Medical Device Expert Group (MDEG)
  • Member of the MDEG VIGILANCE Expert Group
  • Vice-Chairman of the European Association of Authorized Representatives 
  • Member of the Ethics Committee of the Medical Council (Aerztekammer) for Lower Saxony
  • Previously: Lead Auditor with the Notified Body TÜV Rheinland 

 


PROF. S├śREN ASKEGAARD
University of Southern Denmark

Søren Askegaard is professor of marketing at University of Southern Denmark in Odense.
His research interests generally lie in the field of consumer culture therory. Current research projects include globalism and localisms in consumer culture and body culture, health adn morality in consumer culture.

Delegates will be able to fine-tune their offerings to the EU Market Place.


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