EU MDR Implementation: a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 2 of 3)

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 2)

Costs associated with MDR implementation

 

Most of you have thoroughly read through the MDD and the MDR? In comparison the MDD is a small document. A mere 23 articles and 13 annexes. The MDR is a good 170 pages, 13 articles and 16 annexes.

 

Being more prescriptive obviously has an impact on the business that must comply. Which leads to the first topic: Cost.

I borrow from a Medtech Intelligence Cost enquiry the website ran in October 2018, not that long ago. They asked the respondents for an estimate of the costs associated with the switchover from MDD to MDR. A month later they published the results.

 

Medtech Intelligence bucketed reponses into categories of 0-2%, 2-5%, 5-8% and 8%+.

The largest category was the 8%+ category with 32% of the respondents. Judging from the results, the mean value was 5%.

 

The enquiry gives some information, but in reality, it doesn’t say much. For one, the article doesn’t say how many companies responded. Nor does it say what is meant by EU revenue? I presume it is one year’s revenue? Are the costs spread over one year? Are they ongoing?

 

The folks from KPMG who authored “The race to EU MDR compliance” together with RAPS, are here with us today. The report does not address cost specifically but is clear that many companies consider cost a significant barrier to meeting the MDR requirements.

 

Maybe KPMG can survey and report on MDR implementation costs for subsequent EU MDR report? I’d be most interested to read about their findings.

 

Cost Factors

 

Scope

 

A first factor which impacts your costs is what products are covered under the scope of the MDR.

 

The scope has grown. What was an accessory under MDD is now a medical device. What was an accessory of an accessory and not covered under MDD is now an accessory and covered under MDR.

 

Besides, your products may have been up classified. If you make software, you probably fall into this category. Or maybe you make a Reusable Surgical Instrument – a new category has been created for your product: Class I reusable surgical instruments. Or maybe you make a product that has no medical purpose, and now fall under the MDR, or software.

 

Any device which is newly classified or unclassified must comply with MDR the day the MDR is applied.

 

Class I devices must be compliant the day of application. All other devices can continue to be sold under MDD, till the certificate runs out or 2024 whichever comes later.

QMS Updates

 

Another huge impact on costs is the requirement for a fully integrated Quality Management System which includes feedback from mandatory active the Post Market Surveillance activities. The MDR prescribes a complex fully integrated set of requirements covering such areas as clinical evidence, usability, risk-management, Post Market Surveillance and labeling.

 

I want to stress that these requirements are fully integrated meaning that your post-market surveillance needs to inform your clinical evidence, possibly the use of the product, the labeling and the instructions for use. The MDR requires that you constantly update your technical file based on your Post-Market Surveillance findings.

 

The cycle is mandatory for each of the different product classes. Only the frequency and the thoroughness depend on the risk class. frequency of the cycle

 

Having to constantly collect and process and integrate post-market date into your feedback loops will requires ongoing, recurring expense. Before you can even start collecting and processing the data, you will have to modify your Quality Management System to accommodate these new requirements.

 

The first thing the Notified Body will do is review your Quality Management System and certify it under MDR. Implementing ISO13485:2016 will meet most of the requirements. Besides, ISO13485:2016 is being looked at by the FDA and fits MDSAP as well. Modifying your QMS to accommodate the processes prescribed by the MDR constitutes a one-time, fixed cost.

 

Updates to your Technical Files

 

MDR places a lot more requirements on your technical documentation, particularly in the area of clinical evidence. As a result, you will most probably have to update your technical documentation for each of your products-product families.

 

For instance, for certain products, you can no longer quote clinical evidence related to a competitor’s equivalent product as part of your own technical documentation, unless, you have an agreement with your competitor that you’re allowed to use their data, and that they will update that data over time. So, you’ll be forced to collect your own data from your own device.

 

On top of that, you will be expected to include a Post Market Surveillance Plan as part of your Technical Documentation. This Plan must lay out how you are going to actively collect Post Market data and how you’re going to integrate the results back into the risk management plan, the clinical evaluation report, the label, the instructions for use, etc.…

 

Updating your Technical Documentation has two cost components. First and probably the most expensive component is when you have to collect your own clinical evidence. Second is the rewrite of the technical document to meet the requirements.

 

Cost Impact

 

To estimate cost impact, I’m quoting information from Oliver Christ, CEO of ProSystem, an NSF company based in Germany. The company tracked work performed to:

 

  • upgrade both their customers internal and external systems (including such requirements as contracts you have to negotiate with your Economic Operators) and to
  • upgrade the technical documentation to meet the MDR requirements.

 

and published findings on the internet. They observed that the fixed one-time costs of modifying the internal and external systems ran anywhere from anywhere from between 30 man-weeks for a small start-up to 30 man-months for a large multinational company.

 

The company also estimated the one-time costs associated with upgrading the technical documentation to comply with MDR as a 55-day effort on average plus or minus 15 days. The time required to maintain the technical documentation in compliance with MDR at about 10 plus or minus 5 days for each technical file.

EU MDR Implementation; a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 1 of 3)

 

EU MDR Implementation; a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 3 of 3)

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