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MDR Impact on MDSAP Countries

#11
OK, if I understand you now, I think you confused things by bringing up MDSAP, which has nothing to do with it. Devices that in whole or in part on their CE certification for market access to other countries, then yes, their access to those markets could be in jeopardy after May 26. I think it is probably up to each country's regulatory authorities to decide how they want to handle this.

PS It is rarely fine to supply Class III devices in the US based on FDA 510(k). However, a device that is Class III in the EU could be Class II in the US. Although risk-based classifications tend to be similar worldwide, they are established by each regulatory authority independently. So a device may be one class in one regulatory jurisdiction and another class in another regulatory jurisdiction. Otherwise, if the FDA reviewed the 510(k), and the FDA didn't say a PMA was needed, then a PMA is not needed. But this would be an extremely rare situation, and I would definitely not latch on to the idea that devices that are Class III in the US do not need a PMA.
 

medwise

Involved In Discussions
#12
OK, if I understand you now, I think you confused things by bringing up MDSAP, which has nothing to do with it. Devices that in whole or in part on their CE certification for market access to other countries, then yes, their access to those markets could be in jeopardy after May 26. I think it is probably up to each country's regulatory authorities to decide how they want to handle this.

PS It is rarely fine to supply Class III devices in the US based on FDA 510(k). However, a device that is Class III in the EU could be Class II in the US. Although risk-based classifications tend to be similar worldwide, they are established by each regulatory authority independently. So a device may be one class in one regulatory jurisdiction and another class in another regulatory jurisdiction. Otherwise, if the FDA reviewed the 510(k), and the FDA didn't say a PMA was needed, then a PMA is not needed. But this would be an extremely rare situation, and I would definitely not latch on to the idea that devices that are Class III in the US do not need a PMA.
should have clarified further by stating class III in EU which are classified as II in US therefore the US manufacturer is able to pull out from EU due to MDR requirements and of course ROI.

So going back to my question - can you highlight high-level impact of MDR on US based companies who have CE under MDD and supply in Australia, Canada, Japan and Brazil.
 
#13
I haven't heard anyone talk about this, except a few consultants remind everyone that other markets may be affected. Pretty much all of the discussion has been by and about companies that are planning (or at least hoping) to stay in the EU, rather than those that are planning to withdraw.
 

medwise

Involved In Discussions
#14
I haven't heard anyone talk about this, except a few consultants remind everyone that other markets may be affected. Pretty much all of the discussion has been by and about companies that are planning (or at least hoping) to stay in the EU, rather than those that are planning to withdraw.
What I am experiencing is that companies are now rationalizing their product portfolio due to MDR and only getting CE marking for specific product line where there is ROI. Which makes sense but it does affect those markets which rely on CE. Hence my question so that I can understand what other are doing.
 

cmeby

Involved In Discussions
#15
We have our MDSAP certificate, and sell in Australia. Before we had our CE Mark and went for ARTG listing, we were advised by our NB at the time that the MDSAP would be enough for Australia. We were doing our CE application anyway, but according to our NB, it would have been enough to do our MDSAP with Canada, USA and Australia.
I would confirm with your NB on this, as I am just relaying what we were told.
It was my understanding that a company could cut out the CE Mark and hence EU market entirely, and focus on the other markets through the MDSAP.
 
#16
It was my understanding that a company could cut out the CE Mark and hence EU market entirely, and focus on the other markets through the MDSAP.
Australia's ARTG accepts both CE or MDSAP and it is perfectly acceptable to drop CE if you aren't interested in selling in the countries that require it. One does have to be wary of countries that require CE certification while not being part of the EU (Turkey, for example). We had to make an ironic decision to drop the CE mark as the costs of the new MDR outweighed the sales we generated, however the only sales we had for a certain product was in Turkey.
 

Ronen E

Problem Solver
Staff member
Moderator
#17
we were advised by our NB at the time that the MDSAP would be enough for Australia.
Australia's ARTG accepts both CE or MDSAP
It's very important to understand what exactly a statement "MDSAP suffices for Australia" (or similar) means. For higher class devices, Australian regulations have 2 main aspects: QMS (or more generally, system); and device. MDSAP only covers system. EC certification (CE mark) covers both. 510k (which is now also recognized for Australian clearance) only covers device. So if a manufacturer/device has EC certification, ARTG inclusion is mostly an administrative process, which is not the case in the other above-mentioned scenarios. Most likely, the above NB statement was misunderstood - they probably stated (or intended) that MDSAP suffices in Australia to cover the system aspect.
 
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