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Webinar : The Impact of the new MedTech EU MDR/ IVDR Regulations
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2018-01-23
When: Tuesday, January 23, 2018
11:30 AM
Where: Webinar
Canada

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Webinar – European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR)

 

The Canadian Trade Commissioner Service invites you to participate in a webinar on the upcoming overhaul of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR). The webinar is for Canadian Life Sciences companies who do business in the EU.

The changes will improve coordination between National Authorities, increase transparency, create a database of devices of unique device identification, and strengthen vigilance and market surveillance amongst other things. That said, the revisions will mean that Canadian companies selling (or hoping to sell) medical devices into the EU will need to be aware of the changes and be diligent in their approach to ensure they meet the new standards in the timeframes laid out.

Although the May 26, 2025 deadline to be in compliance may seem generous, the process to transition from the current Medical Device Directive (MDD) to Medical Device Regulations (MDR) will not be easy or fast. Canadian clients doing business in EU member states will need to comply with the new regulations by that date. 

In order to ensure that Canadian clients are aware of their responsibilities under the new EU MDR and IVDR, we have organized this webinar to ensure that TCS clients can start planning accordingly.

Why should you participate? You will:

  • receive an overview of the EU MDR and IVDR from an expert himself
  • gain insights on the economic impact and budgetary needs for companies in preparing for the new regulations
  • learn about the risks of non-compliance
  • find out what Canadian companies need to do in order to be compliant by May 26, 2025

This masterclass webinar will last 60 minutes, split into two portions:

  • 30 Minutes – Presentation by Mr. Beautus Hofrichter, Managing Director, ConCep+
  • 30 Minutes – Q&A session with our expert. 

This webinar is hosted by the Canadian Trade Commissioner Service.

 

Click HERE to Register 

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MEDEC is the national association representing the medical technology industry in Canada. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our publicly-funded health care system. We are committed to supporting the growth of a strong and vibrant medical technology industry that contributes to Canada’s innovation economy.



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