How to write a clinical evaluation report (CER) for CE Marking

Rob Packard

Ship & Print Your FDA eCopy

October 2015

< 1 min reading time

The most common nonconformity identified by reviewers of a CE Marking submission is an inadequate or missing clinical evaluation report (CER). Preparing a CER is time consuming, but if you have a good protocol and procedure the process does not need to be difficult.

Essential requirement 6a, the clinical evaluation report (CER), is required for all medical devices that are CE Marked. Up until the Medical Device Directive (MDD) was modified in 2010 (i.e., 2007/47/EC), only high-risk devices required a clinical evaluation report. After the MDD was modified, a CER was required for all medical devices–even Class I devices that do not require a Notified Body.

MEDDEV 2.7/1 (http://ec.europa.eu/DocsRoom/documents/10324/attachments/1/translations/en/renditions/native) indicates that are there are three options for preparing a clinical evaluation report:

1. perform a clinical study and summarize the results,
2. perform a literature search of clinical study articles, or
3. a combination of the first two options.

The most common method chosen is to perform a literature search of clinical study articles. In order to use this approach for meeting Essential Requirement 6a, you need to have a pre-approved literature search protocol and you should consider writing a procedure to give people direction on how to perform the evaluation.

In my procedure for clinical evaluation reports, I include a template for a literature search protocol. In addition, my procedure includes the following elements:

– qualifications of individuals performing the evaluation
– rationale for selection of literature databases
– rationale for keyword selection
– inclusion/exclusion criteria for clinical study articles
– how to address the device risks in the clinical evaluation report
– inclusion of post-market surveillance data
– appraisal of clinical literature
– recommendations for reviewing and updating your clinical evaluation reports (CERs)

If you are looking for a procedure and literature search protocol for preparing a clinical evaluation report (CER), please visit today’s blog I posted (http://medicaldeviceacademy.com/blog/).

source: https://www.linkedin.com/groups/2070960/2070960-6064408733520314373

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Posted by Rob Packard

Asked on October 26, 2015 12:00 am

1820 views

	Private answer Juha Leppänen I would start with 'intended purpose/use' phrase. Is it even possible to prove that claim with a scientifically and statistically performed study? When possible, use 'predicates device' as a sample and then use qualified experts to define your study. Marked as spam Report spam
	Private answer It is amazing how difficult this process has become just over the last couple years. Previously, providing risk information, some level of post-market surveillance and clinical literature was acceptable, but lately we've notice there has been a big push back on the format of the data; exactly how the data is presented. We been asked to present information in tables in addition to in the body of the text. We have also had some push back on the physician review of the data - where the NB clinician had different and additional warning she wanted to see. Lastly, we have seen a real tightening on the scoring. The MEDDEV defines the scoring levels pretty well but if you present multiple 'fair' studies because the technology is new; we've been told the product was 'not ready yet' by a reviewer (even though there were two 510(k) and 1 year of USA data available and two other CE marked similar products on the market). I think the pendulum has swung to far to the other side. Marked as spam Report spam
	Private answer Jonathan Phillips What about comparison's with a predicate device? Marked as spam Report spam
	Private answer Juha Leppänen Your study must provide positive outcome for risk/benefit analysis. Benefits must be greater than risks. With proof. Basically it boils down to risk analysis, how good it is and what it covers. Marked as spam Report spam
	Private answer Taneli Vääräniemi Comparison with a predicate device might be a nice plus for CER. But, the comparison against appropriate harmonized vertical standard(s) (IEC/EN 60601-2-xx) is much more better. Marked as spam Report spam
	Private answer Brian O'Connell BSc MSc 6ΣGB-13 Plus experience Great Article Rob & Good point Jonathan - comparison with predicate devices like the 510k process give less Risk for new devices coming to market. Also I wonder what impact the new MDD directive will have on Clinical Evaluations? Regards Brian Marked as spam Report spam
	Private answer Jonathan Phillips There does seem to be so much 'grey' in this area that it is difficult to get a definitive method as so much is dependent on personal experience and opinion. Marked as spam Report spam
	Private answer Brian O'Connell BSc MSc 6ΣGB-13 Plus experience Good point CER is a potential area for improvement, When preparing a submission they appear to be the most subjective part - Any other opinions? Marked as spam Report spam
	Private answer Alex Bromberg How often do you turn to contractors/consultants to write CER's? Do you tend to be more likely to use internal resources? What do you see as the pros and cons of bringing someone specialized in to handle this kind of work? Marked as spam Report spam
	Private answer Jonathan Phillips It is not really my area of expertise but considering the experience and expertise required by notified bodies I think it will be difficult to complete them in-house for smaller companies Marked as spam Report spam
	Private answer Marie Suetsugu We used a well-known consulting company (though I think the person was/is only contracted and not a full-time employee there). And yet needed to make corrections here and there, including grammatical mistakes (we are in a non-English speaking country) :-/ But the template was helpful. Now that we've got the template, we may do it on our own next time (for the re-evaluation we are expected to conduct every 5 years...?). Marked as spam Report spam
	Private answer Karen Boyd, ASQ CQA I previously worked for a small med device manufacturer, (less than 35 employees), was responsible for everything QA / RA, and managed to write their CER in accordance to the MEDDEV with only minor additions required at Tech File review. In other words, the MEDDEV guidelines are pretty clear and relatively "harmless" to adopt. Marked as spam Report spam
	Private answer Jonathan Phillips Hi Joanne that's why I mentioned it. Marked as spam Report spam
	Private answer Jonathan Phillips I did not want to hijack his post so thought would just throw it in there! Are you in Cardiff as well? Marked as spam Report spam
	Private answer Taneli Vääräniemi Joanne - Is the requirement stated in 2.7.1? Marked as spam Report spam
	Private answer Juha Leppänen You just must have clinically proven postive risk analysis clinical study outcome that you are willing to discuss with EU authrities. Apac and US authrities just may follow your studies. Marked as spam Report spam
	Private answer And all this will change if the new Medical Device Regulations are implemented, as we will no longer be able to demonstrate equivalence with any marketed devices with comparable ("equivalent") clinical, technical, and biological characteristics, but now will be limited to demonstrations of equivalence to devices the same manufacturer (we) currently has placed on the market. In other words, there will be few opportunities for demonstrating equivalence to allow the literature route to be pursued, and, consequently, clinical data will have to be sourced from clinical investigations. Great idea! To satisfy state-of-the art requirements, let's all run new clinical investigations on devices that are already legally marketed and CE Marked. Marked as spam Report spam

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