The DIY Clinical Evaluation Report – Do You Really Need A CER Writer?
So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing the technical file.
One of the more common tasks is taking a look at the Clinical Evaluation Report. Based on a few of the articles’ you’ve read (or what you gathered from MDR itself) it’s clear that writing the CER is significantly more involved this go-round compared to your MDD cert.
But you’ve gotten quotes that range from a few thousand, up to 50+ from some of the bigger consulting firms. Timelines and deadlines seem murky at best, and your’e still not 100% certain that having an outside shop will even get you the report you need to certify at the end of the day. No one hates ambiguous (and huge) consultant proposals more than us, it’s the main driver behind our entire philosophy at CiteMed.
What Can Be Done? Your Medical Device Clinical Eval Game Plan
The natural next question is, “Well shoot, can we just do this thing ourselves?”. When looking at a 70k and up bill, it’s the right question to be asking.
Today I’m going to talk you through how to internally decide whether or not you should be drafting and maintaining your own CERs. Am I biased because CiteMed boasts a hyper-focused CER Writing team?
No. We don’t like to slant our advice based articles, and we’re just as happy to send you on your way with a proven CER Template , and a license to our systematic literature review software to help save you a big chunk of time.
Evaluate Your Staff Questions for Medical Device Companies Pursuing EU MDR
There are two main questions you need to ask before pursuing a clinical evaluation report internally. Both can be answered on a continuum and don’t necessarily have to be 100% yes, or no in order to proceed.
Is My Team Qualified?
Currently, Notified Body’s are using the Meddev definition of a qualified writer. This comes from Meddev 2.7.1 rev4, section 6.4 describing who can be a qualified person to evaluate your medical devices. Your writer will need either:
- A Higher Education Degree in the respective field + 5 years documented experience (clinical experience)
OR
- 10+ Years documented and Relevant Experience
On top of that already tall order, relevant experience should be demonstrated in the following areas:
- Clinical investigation design & bio-statistics
- Information management/retrieval (experience performing systematic literature review)
- Regulatory Compliance and Requirements
- Medical Writing Expertise (published papers, demonstrated medical writing successes)
The CV of the cer writer will be scrutinized during your audit and sent back with a big non-conformity if they don’t add up. Note that relevant experience should be applicable to the clinical evaluation of data in some way (through medical writing, performing investigations, successfully completing similar regulatory submissions etc.).
If your Quality manager or team don’t have all of that, it’s safe to say that their signatures won’t be acceptable on your CER submission. But don’t despair just yet, for the determined internal team I’ll propose a solution near the end of this article that can still save your budget.
Does My Team Have Enough Bandwidth?
This is perhaps the more important of the two questions when assessing your need for an external cer writer. We’re strong optimists here at CiteMed, and we believe that given enough time a dedicated regulatory or quality persons can generate an acceptable clinical evaluation report. Sure, they might need to do a lot of learning on clinical data analysis, how to interpret clinical outcomes through the lens of medical indications and patient safety, read and perform comprehensive analysis on scientific literature… but it really can be done.
The real question is are you going to give them that time to make it happen?
Our most senior writers can come in cold onto a project and generate a review in more or less these amounts of ‘billable’ hours:
- A comprehensive systematic literature review (required) – 50-65 hours
- A fullly drafted with revisions Clinical Evaluation report – 60-80 hours
Now that includes a lot of things, but you get the general idea that writing these documents isn’t something you can have your folks do over their lunch breaks this week. It requires big dedicated time blocks to research and writing.
When was the last time your Regulatory lead had 2 consecutive hours free? If workloads are light, and EU MDR is the sole focus the answer might be that their schedule is clear until this gets done. Great, because that’s the kind of focus required to making it happen.
If you are simultaneously performing 3 other global submissions, and keeping up with the flow of complaints and your committed post market surveillance and follow-up clinical investigations then things might be a little too hectic to try and tackle this type of project.
The Productivity Killer – Literature Reviews for EU MDR and IVDR
You probably noticed in the above section in included a pretty big time frame chunk for the systematic literature review. That may come as a surprise for those of you familiar with ce marking under the MDD previously (where literature standards were flimsy at absolute best).
Performing a Systematic literature review that will be up to MDR standards is not a trivial task. You need to search globally, include a seconary search to address the State of the Art treatment for your medical device/therapy and it all needs to be presented a concise way that an auditor could replicate easily.
Many smaller teams manage their own literature (and many are starting to wise up to the time savings gained by using our slr tools), so this is doable but very time consuming. Again, qualifications of the evidence evaluator will apply here.
If you need a hand getting started, we offer our complete literature review process for you to replicate via our protocol documents. Or you can sign up for our free systematic literature review training and certification program at citemed.io.
The Declaration of Interest for EU MDR Clinical Evaluators
All evaluators are required to submit a dclaration of interest now along with the clinical evaluation report. This is meant to disclose any financial benefits from receiving device approval (like if your cer writer also owns a significant amount of shares in the company that manufactures the device.
While conflicts can appear blatant, it doesn’t necessarily mean that you can’t achieve this internally and completely author your clinical evaluation report. It does however open you up to the Notified Body question of objectivity. For example if your evaluator also designed the device, and also happens to own 20% of the company… it’s very unlikely you’d be able to convince an auditor that they have truly performed an ‘objective’ clinical evaluation.
A Compromised Path to Internally Written Clinical Evaluation
If answering the above two questions hasn’t 100% green-lit your internal clinical evaluation project, there may still be away to get your document written and approved without extreme cost.
Write the draft yourself, and hire an external reviewer (CER writer) to review your draft and clinical data, and data analysis.
CERs don’t have to be written in a vacuum by a single person, and Notified Bodies will always feel better about your draft if an independent (and reputable) group has double checked your clinical evidence and analysis. It’s much cheaper to pay an outside shop to simply review and provide feedback (Can range from 10-25 billable hours).
But buyer beware, you might not like the feedback. We have in several instances performed this kind of review for clients and found systemic issues with the document structure and argument. As long as your team is willing to take and apply feedback (taking more time, of course) you’ll find this outside perspective well worth the cost of a few thousand.
The Final Word On Your Medical Device Clinical Evaluations Dilemma
By now you should have a high level understanding of medical device requirements for clinical evaluation. The regulations are not forgiving under EU MDR certainly, but a motivated team (given enough time and resources) can certainly pull through at the end of the day. You should be able to answer:
- Does my team have the qualifications?
- Does my team have the time?
If the answer is a resounding yes (make sure you’re being realistic on both fronts), then you certainly have our support in pursuing your own project and saving some of that precious regulatory budget.
However if your team is already over-stretched, and completely green in terms of clinical background then we’d strongly urge you to consider the hiring of an external expert as an investment in your devices clinical basis, and ultimately minimize the pain down the line due to regulatory delays or rogue audits.
As always, wishing you fair winds and smooth navigation of the regulatory waters in Europe.
Sincerely,
-Ethan and Team CiteMed
