July 30, 2021

Clive Greenwood | What Does The EU Medical Device Regulation Tell Us About Compliance’s Future? Be Afraid!

In this episode...

Renaud Anjoran is joined again by Clive Greenwood, an expert in product compliance for a new episode following on from the first episode they recorded about product compliance (which covered the main compliance challenges faced by importers).

This time they're looking at the future of compliance standards by examining the new Medical Device Regulation (EU) 2017/745 (MDR) which they believe signposts how future regulations will evolve and will definitely heavily impact you if you're a medical device importer and, soon, for many other product types in all likelihood.

So, how much of a change is this regulation and how could it change what you have to go through and provide to get your products certified in future? Let's put it this way, if you're not 100% compliant be afraid as the authorities are going to come for you and now they have teeth!

 

Show Notes

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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