SBS - The Best Value in QMS software

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
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
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
S MDR GSPR Standards EU Medical Device Regulations 1
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 3
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 2
C MDR Classification Rule 10 EU Medical Device Regulations 13
C MDR software classification EU Medical Device Regulations 12
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
R Products not within the MDR grace period EU Medical Device Regulations 1
shimonv MDR transition checklist EU Medical Device Regulations 0
K Re-packaging under MDR EU Medical Device Regulations 3
Ed Panek Upcoming NB MDD ---> MDR Crunch EU Medical Device Regulations 0
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
JoCam Rental and MDD versus MDR EU Medical Device Regulations 1
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 5
Raisin picker CECP, consultation according to Art 54 MDR EU Medical Device Regulations 1
K Question on MDR classification EU Medical Device Regulations 4
M STED vs MDR EU Medical Device Regulations 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 6
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
P EU MDR Translation of Product Name EU Medical Device Regulations 3
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 6

Similar threads

Top Bottom