Now that the EU MDR deadline is passed, how do you sell your device abroad?

Complimentary Webinar 2:00 to 3:00 PM ET, July 18, 2024

Sponsored by:

As the EU Medical Device Regulation (MDR) deadline has passed, medical device manufacturers must explore alternative avenues to sell their devices abroad. Leveraging schemes such as MDSAP, Swissmedic, and UKCA in conjunction with ISO 13485, can facilitate market access in various regions. 

This presentation describes options available to manufacturers who wish to access markets other than the EU. 

Strategies that will be helpful in navigating the following options:

  • Medical Device Single Audit Program (MDSAP): MDSAP is a program that enables medical device manufacturers to undergo a single audit to satisfy the regulatory requirements of multiple jurisdictions, including the United States, Canada, Australia, Brazil, and Japan; with a combined population of 733 million.
  • UKCA Marking: Following Brexit, the United Kingdom (UK) introduced its own regulatory framework for medical devices, known as the UK Conformity Assessed (UKCA) marking. This entails conformity assessment by a UK Approved Body.
  • Swissmedic Approval: Following the non-renewal of the Mutual Recognition Agreement (MRA) between the EU and Switzwerland, to sell medical devices in Switzerland, manufacturers must obtain approval from Swissmedic - the Swiss Agency for Therapeutic Products. Swissmedic evaluates medical devices based on safety, efficacy, and quality standards before granting market authorization.


Ibim Tariah, Ph.D., Technical Director. Medical Devices, SGS North America Inc.

Dr Tariah’s European regulatory affairs experience spans over 25 years and includes knowledge of combination devices incorporating biologics, drugs and drug-biologics together with Quality Management Systems Assessment of Medical Devices. His expertise lies in innovative non-active vascular, orthopaedic & dental, and other long-term implantable devices.


Gregory Jacobson, Sales Director – Medical Devices, SGS North America

Greg Jacobson is the Director of Sales for the medical division at SGS North America. As a senior sales and medical device professional, he contributes to strategy, recommends resourcing requirements, and improves sales processes to drive client satisfaction. Greg has many years of experience in medical devices certification sales, where in the last 10 years he was responsible for managing high-risk device accounts. He has also held other sales roles both inside and outside of the TIC Industry.

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