Looking For A World Class CER Writer for your EU MDR Submission?

EU MDR has certainly made things more difficult for manufacturers seeking the CE mark, especially in regard to Clinical Evaluation.   If you are in the market to try and source some help on your CER,  this article will walk through a detailed process to help you:

 

World Class CER Writer for your EU MDR

  • Get clear on what you need in a CER
  • Establish a rubric for evaluating potential CER writers
  • Identify the strategy to best collaborate with your writers (Outsource,  collaborate,  review and advise only etc.)

 

By the way, if you want to skip the info and see our full CER processes (we have a strategy for every team size and budget) you can get in touch with us here.
 

Identifying Your Clinical Evaluation Report Needs for MDR

Before you head off and hire the closest CER writer,  it’s crucial that you fully identify your needs.  How much of the document do you need drafted?  Will you require a Literature Search, or have you already performed one?  Who will do the PMS and PMCF planning?  Make sure you have at least a cursory understanding of  the CER document and what will be required for MDR before proceeding on to get a quote.
 
A few of our more popular articles cover an overview of compliant CER writing and Clinical Evaluation Reports for smaller manufacturers.
 

Understanding Your Clinical Evidence and Identifying Gaps

If you want to develop clinical evaluation reports that get approved, an understanding of available clinical evidence is vital. Identifying potential clinical evidence gaps is something that your CER writer should be able to do immediately (and It’s often a great way to evaluate their competency in the regulatory documents discovery phase of a project).
 
Our friends who drafted the European Medical Device Regulation (EU MDR), have written in a significant need for strong evidence of your claims. When selecting Safety and Performance claims for your Clinical Evaluation Report (and Systematic Literature Review), it’s essential that you are able to produce evidence that supports these claims directly.
 
To read more, you can check out our article on the Notified Body clinical evaluation assessment criteria.
 

Be Aware of the State of the Art Strategy vs. Equivalent Devices

In almost all cases of our client’s, equivalence is not used in the final Clinical Evaluation Report (CER). Thanks to MDR, the standards for being able to claim equivalent devices have been substantially bolstered. If you are to claim it, you must have access to all of the manufacturing and safety data of the equivalent device. This is generally only possible if your company also manufactures it. A competitor device will not work for an equivalent devices claim as it did under MDD Meddev. clinical evaluation report (cer)
 
Understanding State of the Art is out of the scope of this article. Make sure your writer is aware of it, and can produce a strategy for you (you will need this for your Literature Search and Review). This is a large and underrated part of what makes a good cer writer.
 

What Are Their Qualifications and Experience?

A very common question we get asked by clients is relating to the regulatory submissions required qualifications under EU MDR. And they are correct to be concerned.

 

What Are Their Qualifications and ExperienceYour writer must be considered by the Notified Body an ‘acceptable’ writer and clinician in order to sign off on regulatory documents to be submitted. What does this mean in reality? An advanced degree (although being an MD is not required) and substantial applicable clinical experience. This is where things become a little bit murky as ‘clinical experience’ can cover a lot of ground.
 
The shortest way to find out about your medical writer’s experience during the interview and selection process, is to ask directly how many submission documents they have authored/signed for EU MDR, and how many of those have been accepted without issue.
 

Assess Their Regulation Knowledge and Current Grasp

A professional literature search and cer writer should be up to date on the latest regulations and requirements, be knowledgeable about medical devices and their therapeutic indications, and be strong on clinical knowledge. Typically medical writers will have broad experience within the general therapeutic area of your device, if not the device type’s specific intended use.
 
The knowledge base of the medical writer depends on what type of CER you need. If your device is Class I or Class II and relies heavily on clinical data from the literature and post-market surveillance data, you need a writer with general clinical and therapeutic knowledge, but you might not need someone who is a specialist in clinical trials data and processes. If your CER is for a Class III or a novel device, you will need a cer writer with a good understanding of pre-clinical data and clinical trials.
 

Pick Your Strategy – Getting Your Clinical Evaluation Report Written and Approved (And Under Budget)

While many of the larger ‘consulting’ firms in the Regulatory Affairs industry might not deviate from a set project plan, there are multiple alternatives to consider for the drafting of your Clinical Evaluation Reports in collaboration with medical writers.

 

Clinical Evaluation Report WrittenAt CiteMed, our CER Process (get the details about it here) had to be constantly overhauled to meet client’s specific workflow and budget needs. The reality is that some manufacturers have experienced teams, but no free time. While others have time, but not enough experience with MDR to be certain of their final drafts.
 
Because of this, a manufacturer should consider a what we call a ‘hybrid approach’ , especially if there are budgetary concerns. Do you need the whole document and literature review to be fully outsourced? Or do you simply need some guidance and compliant templates to work from? Sometimes the best plan is to collaborate with your medical writers, not just hire them and wait for the results.
 

Outsource the Literature Review – Save Your CER Timeline

We recommend that almost all clients outsource the literature review portion, as it’s the most time-consuming and arduous process (contact us to hear about the tools we have to make this part of the review more efficient).
 
Fundamental for the success of your CER, the literature review is a critical step in demonstrating the safety and compliance of your device. For Smaller and Medium Enterprises (SMEs) who do not manufacture devices with equivalents on the market, the literature search can comprise a large part, if not all, of the clinical data included in the CER. Furthermore, Class I and Class II CERs rely heavily on clinical data from literature reviews and require emphasized focus on the literature search planning and execution.
 

Bandwidth and Capacity

Lastly, you need to consider the timeframes and deadlines involved in your clinical evaluation. If you have to submit the clinical data within a short timeframe, hiring a literature search writer who can commit to the deadline becomes vital. Most professional literature search writers can offer different time frames at different prices, so you can choose the solution that works best for your company.
 
Lastly, you need to consider the timeframes and deadlines involved in your clinical evaluation. If you have to submit the clinical data within a short timeframe, hiring a literature search writer who can commit to the deadline becomes vital. Most professional literature search writers can offer different time frames at different prices, so you can choose the solution that works best for your company.
 

Should I hire a CER Writer or Literature Search Writer When I already have a regulatory team?

Even in companies that already have a well-established regulatory and quality department, hiring an external literature search writer might be worth the expense.
 
In smaller companies, the regulatory and quality department frequently comprises a single person or teams of one to three people. In larger companies with global reach, ensuring regulatory and quality compliance over several markets and product lines is complicated and time-consuming, even in larger teams. In either scenario, internal staff might simply not have the time required for a well-planned and well-executed literature search.
 
Even if your employees have the time and willingness to take on the literature search, they might not be the best fit for the job. The literature search and review is a complicated process at best and each stage must be planned and executed correctly and systematically. Most regulatory people have scientific backgrounds and are well-versed in science and medicine, but might be lacking in analytical reading and writing skills.
 
For manufacturers in non-English speaking countries, requirements to avoid translation costs and write and submit the CER in English adds a second layer of difficulties for staff who are not 100% comfortable with or qualified for writing in English.
 

How to Find and Hire Your CER Writer

How to Find and Hire Your CER Writer

One of the best ways to find good CERs writers is to ask from referrals from people in your industry. Google searching is another great way (and likely how you’ve come across this article!). In the early days, we even had some success finding folks on freelancer websites.

 

What’s more important is how you evaluate candidates, not how you ‘find them’.
 
When it comes to evaluation, stick to the main principles outlined in this article and you will be able to get a cer writer or team that meet your needs.

  • Know your document (understand from a high level what’s required for your medical device)
  • Know your preferred method of collaboration (hybrid approach, full service) and timeline
  • Check their experience, references, and bandwidth capacity carefully.

If you’re ready to take a look at how the CiteMed team can work with you on your CER project, drop us a line here or read more here

 

 

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