How to Select a CER (Clinical Evaluation Report) Writer

This was a valuable contribution in the Medical Devices Group from member Julie Omohundro, Principal Consultant at Class Three, LLC that was too good not to share more broadly. These are her words.

These are the qualifications I would look for in a CER writer. I would be happy to hear what criteria others have found helpful.

1. Writing experience. Significant experience writing scientific, medical/clinical, and technical content. Experience writing CERs that conform to MEDDEV 2.7.1 would be a plus.

-- Many medical writers will have experience that limited to clinical trial documents such as protocols, consent documents, and clinical study reports; this experience is not particularly relevant to CERs. Some may have experience with summaries of safety and effectiveness, investigator’s brochures, and/or report of prior investigations, which are much more on target. Experience with review articles for a scientific or medical journal would also be on target. 

-- Device RA professionals will have experience with technical content; many will have little or no experience with scientific or medical content.

2. Clinical knowledge. Someone who is knowledgeable in the therapeutic area. Knowledge directly applicable to the specific device’s intended use would be a plus.

-- Medical writers are likely to be strong on clinical knowledge. The only questions to be asked is in which therapeutic areas.

-- Device RA professionals who have managed 510(k)s or De novo petitions that were supported by clinical trials will usually have some level of clinical knowledge. If they have prepared regulatory applications for devices in the same therapeutic area, their clinical knowledge will be more applicable to the CER(s) you need written. Those who have led PMAs are likely to have deep but narrow clinical knowledge, defined by the intended use of their PMA devices.

3. Device knowledge. Someone with knowledge of devices used in the therapeutic area and often in the technology (eg, diagnostics, software, imaging). Knowledge of the specific device type would be a plus.

-- Most medical writers have no device knowledge. Some have knowledge limited to specific devices that were the subject of clinical trials for which the writer developed study documents. Those with broader device experience are relatively few and far between, and most of the experience will be with cardiology devices.

-- There should be any number of device RA professionals who have experience with devices used in the relevant therapeutic area. If the device type is fairly common (e.g., a stent), there will also be a good number who have with the specific device type, which is an obvious plus. If the device is less common or novel, then you can comfortably settle for experience with devices in the same therapeutic area.

4. Regulatory knowledge. Someone with a solid knowledge of MEDDEV 2.7.1 is a must. Knowledge of the knowledge of the current version, an understanding of the EU regulatory framework for devices, especially the role of the notified bodies in review of a CER, would be pluses.

-- Medical writers could have through knowledge of MEDDEV 2.7.1, but most are pharma writers and may never have heard of it. Some know a good bit about the EU regulatory framework for medical devices, but most know little to nothing about it.

-- Device RA professionals who work with CE marked devices will a solid understanding of the EU regulation of medical devices, but many will not have a solid knowledge of MEDDEV 2.7.1. I think the main strength here is their potential understanding of the review of CERs by notified bodies, the difference between review at certification and renewal versus periodic annual review, and how everything that is going on in the EU is likely to impact that review, and what that may mean for your CER.

In applying these qualifications, it is important to weigh the specific needs of your CER. A Class III CER rests heavily on clinical trial data, and therefore needs a writer with a good understanding of clinical trials, most likely a medical writer or a device RA professional with PMA experience. Class I and Class II CERs rest heavily on data in the literature and post-market surveillance data, so clinical trial knowledge is less critical. I also think there is a difference in what is needed to write a new CER from scratch, update an existing CER to add new data, or to update an existing CER from Rev 3 to Rev 4.

You also need to consider what you will bring to the effort. If you have an MD or other clinician who is going to be actively involved in the preparation of the CER, then the clinical knowledge of the writer becomes much less critical. Similarly, if someone knowledgeable about the device technology is going to be actively involved, then writer’s technical knowledge becomes less critical. If you are going to provide the writer with the results of the literature search(es), then the writer doesn’t need to know their way around PubMed; otherwise, they do.

The biggest mistake I’ve seen is to insist on a writer that has all of the pluses, which may be driven more by recruiters competing for a placement than by the device companies themselves. 

For most CERs, a writer with broad content experience, a knowledge of the therapeutic area, a familiarity with devices with the same general type of technology, and knowledge of MEDDEV 2.7.1 will be quite up to the task, and not necessarily easy to find. If you insist on someone who has experience specifically writing CERs to MEDDEV 2.7.1 Rev 4, for the same specific type of device, for the same intended use, you may be pointlessly searching for a needle in a haystack, and also end up paying a higher rate for this unique combination, when it really wasn’t necessary.

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About the author: Joe Hage leads the world’s largest Medical Devices Group(350,000+ members), the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Mr. Hage’s medical device marketing services help companies engage qualified prospects and his family of 10x Medical Device Conferences unites Medical Devices Group members in fun and educational forums each year.

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