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MDR Impact on MDSAP Countries

medwise

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#1
Hello Experts,

I'm seeking a top-level impact summary of MDR on MDSAP countries. Can someone share key impacts or any matrix as a starting point?

Thank you.
Medwise
 
#3
Are you looking for a MDR ↔ MDSAP gap analysis? I'm not sure if I have seen one but this is the place to ask if that's what you are looking for.

For both systems, companies have chosen to withdraw from the respective jurisdictions as they were deemed too high of an investment for lesser return. For my situation, for example, our poor European sales didn't warrant the cost to upgrade for the MDR. When Canada declared MDSAP as the sole QC system, many companies withdrew their products for similar reasons. The Canadian government has always dodged the question when asked for specific numbers of medical device registrations before and after the legislation. I cannot state what the situation is in MDR countries, however our Canadian based company is often approached by MDR based companies for product and have received similar stories.

In my opinion, both situations have caused a decrease in product availability with no real increase in patient safety, but that's an argument for another day.
 
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#4
I don't think there will be any impact on the MDSAP countries. Do you mean what is the impact on the companies that sell devices in these countries?
 

medwise

Involved In Discussions
#5
Hi Watchcat, yes I'm trying to understand the impact of MDR on the companies that sell devices in MDSAP countries.
I don't think there will be any impact on the MDSAP countries. Do you mean what is the impact on the companies that sell devices in these countries?
 

medwise

Involved In Discussions
#6
Are you looking for a MDR ↔ MDSAP gap analysis? I'm not sure if I have seen one but this is the place to ask if that's what you are looking for.

For both systems, companies have chosen to withdraw from the respective jurisdictions as they were deemed too high of an investment for lesser return. For my situation, for example, our poor European sales didn't warrant the cost to upgrade for the MDR. When Canada declared MDSAP as the sole QC system, many companies withdrew their products for similar reasons. The Canadian government has always dodged the question when asked for specific numbers of medical device registrations before and after the legislation. I cannot state what the situation is in MDR countries, however our Canadian based company is often approached by MDR based companies for product and have received similar stories.

In my opinion, both situations have caused a decrease in product availability with no real increase in patient safety, but that's an argument for another day.
Hi Edward, you made a great point about companies withdrawing or limiting their supply to EU due to MDR requirements. This is exactly what I'm experiencing. Hence wanted to understand the impact of MDR implementation on companies (mainly US Based that are CE marked under MDD currently) selling in Australia, Canada, Japan and Brazil. Will we see more companies in the future limiting their supply in EU and what will be the commercial impact due to reduced market access i.e. patient can't access medtech due to redtape!
 
#8
Perhaps you are asking whether the EU will accept a MDSAP certificate in lieu of an ISO 13485 certificate? If so, I don't know the answer, but I think you will not get an answer to your question until everyone is clear on what it is.
 

medwise

Involved In Discussions
#9
Perhaps you are asking whether the EU will accept a MDSAP certificate in lieu of an ISO 13485 certificate? If so, I don't know the answer, but I think you will not get an answer to your question until everyone is clear on what it is.
Ok allow me to clarify. US based companies that currently have CE under MDD are making decisions to not CE mark some of their products under MDR due to high investment for a low return. This is applicable for high risk devices i.e. Class III predominantly. On the other hand, these US companies are fine to supply in US based on FDA 510K rather PMA. This now impacts registrations in Australia for example. Because the TGA relies on CE and Design Examination or expect PMA and MDSAP for Class III. So I was keen to understand what broad ranging impact does introduction of MDR has on these companies who currently sell in MDSAP countries such as Australia, Canada, Japan, US and Brazil.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
Will we see more companies in the future limiting their supply in EU and what will be the commercial impact due to reduced market access i.e. patient can't access medtech due to redtape!
It's possible. Your guess is as good as anyone's.
 
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