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Looking through the Final text of the EU MDR, it’s obvious that although the familiar rules based classifications, risk based review and 3rd party conformity assessment remain, there’s a whole lot of New and the bar is raised much higher. There are many more class III devices, new requirements for software, reprocessing, custom devices and surgical instruments, and an integrated, exhaustive approach to clinical evidence and post market follow up. It’s a huge change to be got through in 3 years against the backdrop of ISO 13485:2016 and MDSAP transitions going on at the same time. Are we going to see a reversal of fortunes, as Europe gets more difficult than US FDA? See http://brandwoodbiomedical.com/almost-there-final-text-of-european-medical-device-regulation-is-published/ for a more detailed look at the changes.  Almost there… Final Text of European Medical Device Regulation is publishedThe Final text of the long anticipated European Medical Device Regulations has been published. The new regulations include some 123 Articles spit into Ten Chapters and Seventeen Annexes. It’s a weighty read, at some 566 pages compared to the 95… source: https://www.linkedin.com/groups/2070960/2070960-6247223310497783811 Marked as spam
 Posted by Asked on March 14, 2017 12:00 am
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I think that with regard to some requirements already the current EU regulations are stricter than the US regulations. For instance with regard to the Risk Management principles, where in EU the "as low as reasonably practicable"-approach is not acceptable. There are also more strict requirements in terms of other issues: Vigilance Reporting, Clinical Evaluation etc.
Another example is the "Enforcement Discretion" applied to Medical Software in the US. So, I don't see the big change here. There are always different focus areas in the different regions. That has not been changed. Marked as spam
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Alberto Della Martina
Hi. It is indeed becoming more difficult to get a CE Mark than getting an FDA clearance. Especially for "non-innovative" devices which can "easily" get a 510(k) clearance in the US, while they have to undergo basically the same process as "innovative" devices to get the CE Mark in the EU. I am already starting to hear small companies and start-ups considering a strategy of US first, then EU...
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Alberto Della Martina
I am already hearing from small companies and start-ups that they are considering a strategy of FDA first, then CE Mark
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Gary Chuven
I wouldn't be surprised if the net result of the MDR is fewer devices available because the requirements are so onerous. BTW, in 25 plus years of dealing with the FDA, I have not found them to be "difficult".
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Arthur Brandwood
Gary Chuven I tink the real area where we may see a market shake out is in IVDs. The new classification rules will mean a transition from "most IVDs are self declared" to "Most IVDs are Class 2 or higher". That's what happened when Australia adopted this classification and the result was the departure of a lot of low volume IVDs and some smaller companies from the market.
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Hany M. EL Debeky
despite the extra cost the manufacturer has to pay due to strict requirements , it is the
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