Hello Anon,
Just to add what Dan has already provided, basically conduct a Return on Investment or ROI on selling the product in the EU. It is absolutely a business decision which should involve the upper management. There is clearly a significant increased cost of doing business in Europe now (which is really short-sighted of the Commission in my opinion). The cost of audits has increased, the Tech Doc assessment are stronger, and now sampling of Tech Doc during surveillance - this can add up to 15k+ Euros every year now where 5 or 10 years ago maybe only seeing around 5k Euro per year. Then this is compounded by the number of Tech Doc files the organisation has to maintain and have audited.
To take a product off the market, let the CE Certificate run out, cancel/obsolete the Declaration of Conformity, and then follow your End of Life process. Depending on your product, shelf life, or usable life, you may need to maintain complaint monitoring and serious incident reporting for a couple years or many years. Definitely create a End of Life plan for the product especially for existing EU MDD products to describe how these are managed through the post market activities until there are no longer products in distribution chain or company stops supporting a product.
I concur with Dan we have seen many companies with even moderate EU sales volume not transition products to EU MDR because of the significant increased cost. My hope is this will not be a significant impact on providing healthcare to patients in Europe, but if anything smaller companies will not be able to compete in Europe and only larger companies can provide medical devices and IVD products in Europe. Hopefully there might be more partnerships with larger companies to small companies helping maintain some of the unique products on the market.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 27-Aug-2021 11:27
From: Dan O'Leary
Subject: CE Mark
A simple cost model will help make the decision.
Estimate the certificate cost as initial and maintenance.
In initial costs, include the application fee to the NB, initial NB audit costs (QMS and technical documentation), preparing the revised QMS procedures, preparing the initial technical documentation, etc. Be sure to use fully burdened costs for the employees working on the QMS and technical documentation. In addition, include any consultants, test houses, purchase of standards, etc. This is the cost to get the initial EU-MDR certificates.
Now estimate the annual maintenance costs. This includes things like updating the technical documentation, preparing PSURs, updating clinical evaluations, annual NB surveillance audits, annual NB certificate fee, etc. This is the cost to maintain the certificates.
Add the initial cost plus five times the annual maintenance cost to get the estimated cost of the certificate. (This is for a product certificate for five years.)
Determine the EU (exclude GB) sales volume for the prior two years for each device on the product certificate. Multiply each sale by the actual selling price, sum them, and divide by two. This gives you the estimated annual revenue. Multiply by five to get the estimated revenue over the certificate life.
Compare them to make the decision. (You should really use margin, but it is not always easy to get from the accounting system. You could estimate it as a fixed percentage of revenue.)
In my experience, many companies with low EU sales volume don't pursue the EU-MDR.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 27-Aug-2021 10:02
From: Anonymous Member
Subject: CE Mark
This message was posted by a user wishing to remain anonymous
Hello,
We are considering dropping our CE Mark, we sell so little on the EU market that the cost of maintaining the certificate doesn't make sense. However, I am struggling to find good information on the pros/cons of doing this and what the process would look like if we did decide to stop selling in the EU. Any help would be appreciated.
Thank you