Sofeast's CEO Renaud Anjoran and Clive Greenwood, a compliance expert, explore the future of compliance standards by examining the new Medical Device Regulation (EU) 2017/745 (EU MDR) which could be the template for future regulations and will certainly affect you if you're a European medical device importer and, soon, for many other product types, too.

You'll learn about the scope of the EU MDR, what it now takes to comply with it, and how this will revolutionise and increase the safety of the importation of medical devices into Europe and, soon, the world.

Listen to this episode here: [ Ссылка ]

SHOW SECTIONS

00:00 - Introduction. 

01:54 - Clive introduces himself and what he does. 

03:28 - What is the Medical Device Regulation (EU) 2017/745 (MDR) and when did it come into effect? 

05:44 - If you import medical devices into the EU and have a CE certificate granted under the old MDD, when do you have to switch and will it be an easy transition? 

06:42 - The Scope of the MDR 

07:51 - Previously customs found it difficult to check that medical devices were certified, will that still be the case?

12:39 - The MDR requires a LOT more information about your QMS and processes in the technical document pack than just samples passing certification before certification can be achieved.

15:37 - Notified bodies now have to take more action to monitor ongoing production after certification.

16:13 - Who's liable now (post-MDR) if there is any trouble with the products? 

20:36 - What happens if it's found that a fake document was submitted or a problem was found?

24:06 - How can companies transition from the old MDD to the new MDR?

30:08 - What if you're planning to bring a medical device to the market soon? 

34:43 - Why is the EU MDR beneficial? 

36:45 - Wrapping up.

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