CER for Class I device

[tebusse]

Greetings,

I work for a very small medical device startup that is currently preparing for placement of a CE mark on our Class I device. I'm new to the CE marking process and understand the basics, however, I'm currently struggling with writing the CER to the MEDDEV 2.7/1 Rev 4 guidance.

I've made a stance with my manager that I do not possess the qualifications that the guidance discusses to write the CER, but my stance has fallen on deaf ears.

We have conducted clinical investigations to support our claims and we have generated clinical data. Am I able to simply utilize this data our sole supportive evidence of clinical safety and performance? Is a literature search absolutely necessary to demonstrate 'state of the art'? Or, am I able to point to standards and applicable testing to the standard as demonstration of 'state of the art'?

Any further advise regarding the CER would be most appreciative.

Regards, Tonia

 

[Marcelo]

Am I able to simply utilize this data our sole supportive evidence of clinical safety and performance?

No, you have to identify all related existing data (including negative ones, if any) as part of the clinical evaluation. One type of data is the data from clinical trials, but it should not be the only one.

Is a literature search absolutely necessary to demonstrate 'state of the art'? Or, am I able to point to standards and applicable testing to the standard as demonstration of 'state of the art'?

Yes, as standards may be viewed as one part of the state of the art, but not the whole state of the art. For example, standards are usually related to safety, not to performance. They also do not focus on clinical benefits (as it depends on the device). Finally (and this explanation is not exhaustive), you also need to identify possible alternative options for treatment/diagnosis/etc. as part of the identification of state of the art and evaluation of benefit/risk ratio.

 

[QAengineer13]

Greetings,

I work for a very small medical device startup that is currently preparing for placement of a CE mark on our Class I device. I'm new to the CE marking process and understand the basics, however, I'm currently struggling with writing the CER to the MEDDEV 2.7/1 Rev 4 guidance.

I've made a stance with my manager that I do not possess the qualifications that the guidance discusses to write the CER, but my stance has fallen on deaf ears.

We have conducted clinical investigations to support our claims and we have generated clinical data. Am I able to simply utilize this data our sole supportive evidence of clinical safety and performance? Is a literature search absolutely necessary to demonstrate 'state of the art'? Or, am I able to point to standards and applicable testing to the standard as demonstration of 'state of the art'?

Any further advise regarding the CER would be most appreciative.

Regards, Tonia

Thank you Marcelo, I believe Marcelo has answered to your question very clearly.

A well-written CER based solely on relevant literature can, under the proper conditions, be an adequate and efficient tool to demonstrate the safety and performance of a medical device. What manufacturers tend to neglect or forget is that in the post-CE-marking phase, when the product is being sold, the CER must be kept up to date, or it is bound to lose its relevance, thus endangering the very existence of the proof of conformity. This is especially true in case of iterative design changes (“design drift”), extensive off-label use (to the degree known to the manufacturer) or when regulations or the guidance change substantially. And finally, new technical developments may necessitate the introduction of newer, state-of-the-art technology, thus making current designs outdated.

"Literature and prospective clinical investigation: Complementary, not mutually exclusive . The key steps are:
a. Formulate a protocol for the literature study, with clear and reproducible outline and parameters for the search terms;
b. Define objectively which data base, languages, peer reviewed journals, etc. shall be searched
c. Using the pre-agreed upon search terms, search the agreed-upon data bases and journals to harvest the articles that will be analyzed and used to create a safety and performance review
d. Based on the Risk Analysis and comparative products and clinical methods, define the parameters, endpoints and criteria for meeting or exceeding the safety and performance criteria;
e. Perform the review and analyze the results in an objective and scientific way, basing the results on the data acquired
f. Formulate a clearly formulated conclusion concerning the objectives of the literature evaluation."

I read a fantastic white paper when I was doing research on CER, please refer attached for your reference,credits to BSI for publishing this whitepaper for guidance.