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
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
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 0
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 2
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 4
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 4
B Herbal ingredients MDR EU Medical Device Regulations 0
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 2
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
A MDR GSPR Checklist wanted EU Medical Device Regulations 3
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
B EU MDR Perscription product guidance EU Medical Device Regulations 1
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
E UK MDR brexit out of sync with EU MDR deadline? Other Medical Device Regulations World-Wide 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
Ed Panek Medical Device News MDR Delayed 1 year (Posted 4/2020) EU Medical Device Regulations 9
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
J PPE, the MDR and EU 2016/425 EU Medical Device Regulations 4
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
dgrainger Informational Postponement of MDR - adopted by the Commission - April 2020 Medical Device and FDA Regulations and Standards News 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
F The EU Drafts Bill to Postpone MDR by a Year (3/2020) Medical Device and FDA Regulations and Standards News 2
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
P MDR Rule 10 interpretation - Active Device EU Medical Device Regulations 3
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
C MDR - Question around software accesories EU Medical Device Regulations 2
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
N Whether your NB is pushing you for MDR? Registrars and Notified Bodies 0
Similar threads


















































Top Bottom