Medical Device Consulting Regulatory Quality Complaince


For this discussion, we start with two annexes within the Medical Device Directive (MDD):

Annex I:  General Requirements stipulate that the overall risk-benefit of a device be understood.

Annex X:  General Reqirements stipulate that a medical device be clinically evaluated.  

The more common, older, way of meeting these requirements was to write multiple independent documents to meet the requirements. However, the right way to think about these requirements is to see them as integrated - you can pull all these requirements together into one document. The Clinical Evaluation Report (CER) should not be seen as a narrow literature review, rather it should present the requirements of both Annex I and Annex X in an overall risk-benefit analysis.  The

The Wrong Way

It is never easy to generate or revise your CER in response to an audit finding during a CE maintenance audit or major re-certification, or a question on a Class III submission is not .

You have rush to understand the "new" requirements for Clinical Evaluation. You rush through getting the literature report done which you model on one of the many "potted" evidence based medicine systems about, you ask a physician or a surgeon to review the output for you and you submit.

Crisis averted for now and you forget about the CER until next time.

All that work, all that cost and no positive benefit to your company beyond the immediate audit response.

The Right Way

It is much easier to proactively see the Clinical Evaluation Report as being the "cap stone" piece in your Design History File. Meet the requirements for the CER and of the General Requirements for Annex I of the MDD within the same document.

The document should write itself as you develop a product.

If you are putting in place CER retrospectively, the investment you make should support your next product iterations.

In both cases, the CER should inform your complaint system, establish and be maintained by the post-market surveillance program and support your selling cycle.

You do the same amount of work in both cases - you just get better value for the dollar spent if you think of the CER in the right way.