MDR Impact on MDSAP Countries

medwise

Involved In Discussions
#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
 
Elsmar Forum Sponsor

Edward Reesor

Trusted Information Resource
#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.
 
Last edited:

Watchcat

Trusted Information Resource
#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!
 

Watchcat

Trusted Information Resource
#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
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.
 
Thread starter Similar threads Forum Replies Date
S MDD to MDR - Tallow Derivatives Impact EU Medical Device Regulations 1
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
Watchcat Impact of MDR on Availability of Medical Devices in EU EU Medical Device Regulations 5
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 0
A MDR and Poland EU Medical Device Regulations 6
Ed Panek Invitation to the MDR Dance EU Medical Device Regulations 5
M EU MDR language-Translation requiremens CE Marking (Conformité Européene) / CB Scheme 1
I What are suitable indicators and threshold values in MDR/IVDR? Medical Device and FDA Regulations and Standards News 3
A Sell-off legacy devices MDR EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
K Definition of SAE under MDR EU Medical Device Regulations 3
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek Clarity from EC on Importer/Distributor roles in MDR EU Medical Device Regulations 9
Pmarszal BS EN 20417:2021 - Implementation Timeline Aligned With MDR? Other ISO and International Standards and European Regulations 1
T Dental lab acrylics and MDR EU Medical Device Regulations 0
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 4
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
B MDR Technical Structure EU Medical Device Regulations 3
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
L Configurable UDI mdr EU Medical Device Regulations 0
O EU MDR labels EU Medical Device Regulations 1
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
E Article 17 MDR - (Re-)Processing EU Medical Device Regulations 0
H Article 22 MDR System EU Medical Device Regulations 16
L REACH compliance with MDR EU Medical Device Regulations 4
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 8
H MDR Article 13(c) EU Medical Device Regulations 6
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 11
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 2
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H MDD VS MDR 2002-218 UK Medical Device Regulations 6
Ed Panek MDR Liability Insurance EU Medical Device Regulations 1
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0

Similar threads

Top Bottom