Inflation has been upon us for some time, affecting almost every business, including medical device clinical evaluation and regulatory compliance. Since the cost of living, materials, and services have increased, manufacturers are struggling to meet their clinical evaluation report deadlines while controlling the costs.
And that creates a problem in budgeting. Since cutting manufacturing costs in medical device manufacturing is pretty difficult, most of the cuts end up in the regulatory and other perceived ancillary departments.
However, is cutting the budget for regulatory compliance even worth it? Is it possible to have an effective regulatory strategy that costs less yet gets the job done? Or is the pressure to cut corners just reducing the quality of work? Let’s find out!
High MDR Clinical evaluation report process
The standards for clinical evaluation reports (CERs) have been more strict under the European Medical Device Regulation (EU MDR) compared to the previous Medical Device Directive (MDD).
The MDR puts a great deal of focus on medical device safety and performance. While that’s amazing news for people who are using the device, the safety and performance requirements are strict enough that manufacturers are struggling to meet them.
The cost especially is a huge concern. Medical device companies are doing more than they have had to do before but with lower budgets or higher prices.
As the EU MDR has upped the game and demands a rigorous evaluation of clinical data for medical devices, you need to collect more data, do more studies and run more analyses. Do you know what all these require? Time and resources.
But, as a manufacturer, you don’t really have a choice. You have to give proof of the device’s clinical performance, safety, and clinical advantages, as well as a risk-benefit analysis.
MDR also requires more medical devices to conduct clinical investigations and clinical trials. Clinical trials can be very expensive and time-consuming, especially when the target demographic isn’t high in number. Meaning you can expect the sales to be low (due to fewer people needing the devices) but have to spend more on clinical trials anyway.
The number of times you have to redo these processes also adds to the cost. The MDR requires you to do regular follow-ups and continue data collecting for most devices in order to collect appropriate safety and performance data. This is a continuous process and hence continues expenditure.
MDR requirements also include expert involvement to some degree. To be exact, the MDR requires CERs, which require clinical evaluation and methodological experts or CER writers. It’s a pretty hefty document, so you really cannot expect to write it properly without a CER expert team or hiring an expert writer.
Plus, you will need to prepare for audits and meetings since the Notified Bodies are more actively involved now as per MDR law. There are also fees to be paid to the notified bodies themselves.
Not to mention you need a lot more staff than the two or three people that make up your regulatory team if you want any of these done.
What should you do?
There is a misunderstanding that the complexity of producing a clinical evaluation is what satisfies the EU MDR requirements. Fortunately, this is not true.
To be successful and comply with regulatory regulations, a clinical evaluation report (CER) does not have to be complicated or lengthy. It just has to be effective and have enough clinical data to defend the intended purpose.
While these strict criteria of the EU MDR can become overwhelming, it is definitely possible to create a high-quality CER while keeping financial limits in mind.
The trick is to focus on writing a good CER but faster. You might be wondering if that will increase the expenditure. Here is the thing, you have to do a clinical evaluation report no matter what if you want to market your device.
If you focus on making a passable clinical evaluation report with people who clearly aren’t experts, you take a huge risk. The work could be delayed, it could be not passable at all, and worse, it could get rejected, and you may not get a CE marking. If any of these happens, your expenditure doubles in that instant.
Since we are on a budget, focus on making decent CERs that demonstrate conformity beyond doubt.
A Clinical Evaluation Plan that Works
The cost of the clinical evaluation process depends a lot on the clinical evaluation plan. The best time to reduce costs is at the beginning. Make a decent plan and cut where you can without affecting the end results.
For example, start by using some of the existing clinical data you found during your literature search that matches the intended purpose of your medical device.
Use existing clinical data from the published literature, post-market surveillance reports, or clinical studies for related products. You should also have some clinical data of your own. But, you can get info on clinical background, medical indications, associated risks, and other data out of the data you already possess and make the clinical data collection faster, hence cheaper.
While making this plan, focus only on the important things and leave out all the frills. The goal should be to be a well-structured and brief CER that satisfies all of the Notified Bodies’ main requirements. Avoid excessive information and deliver a clear and complete review of the device’s safety and functionality. Trust me; the regulatory people will love that.
While you are at it, check out the guidance document for the Notified Body. You will get a checklist of the things they check. Here is our article on that: MDR CER | How Your Notified Body Is Grading Your EU MDR CER (citemedical.com)
Another hack is to get expert help. Seriously, people, you should see how much time is spent trying to find the right way to present clinical data to NB while an expert could tell you that in a minute. If you cannot afford to get a whole package, get a consultation and ask for help in places you could not cut corners.
The cost can go up and down based on the service fees, how much your labs, researchers, and other employees are paid, and how many devices you have. It can even change depending on where you live.
However, before you make the budget, calculate these costs and adjust your marketing strategy. Having an estimation of cost is also a way to save resources!
In reality, poor-quality clinical evaluations can have far-reaching and severe repercussions for medical device manufacturers. A CER is an important piece of evidence for demonstrating compliance with the European Commission. If a CER is poorly prepared, lacks sufficient clinical data, or fails to show clinical evidence, it’s not passable.
You will have to redo it, and even then, you will face delays in receiving CE markings, a potential loss of market access, and a loss of rapport.
What is the cost of the EU MDR clinical evaluation report?
Well, the cost can vary. Depending on where your company is and which devices you are working on, it can get up to thousands of euros.
What is included in a clinical evaluation report?
The CER is mostly about proving the safety and performance of the medical device while showing that the device is compliant with all EU MDR requirements. The document has many parts, but the theme stays the same.