Medical Device Consulting Regulatory Quality Complaince

Inputs: The Birth of the CER

A Matter of Simple Economic Sense

Annex I:  General Requirements of the MDD reuqire that the overall risk-benefit of the device be understood. Annex X of the Medical Device Directive requires that a medical device be clinically evaluated.

It comes down to being simply a matter of economic sense.

Well before many companies start thinking about their CER, they are required to be compliant with ISO 14971 and ISO 62366.  The annexes to these standards provide guidance as to the identification of harms/hazards associated with the design.  Later in the design cycle, FMECA (Failure Modes Effects and Criticality Analysis) will identify the failure modes in design and production process.  These two reviews and the literature review required for the CER are clearly inter-connected. 

The input review of the literature will help identify the Indication for Use and Target Populations.  Within the literature will be data relating to anticipated adverse events for the therapy or similar devices.  This data supports the identification of harms/hazards.

In considering the standard application intended for the device, it is possible to anticipate many harms/hazards related to the device given its means of application/implant.  These help the literature reviewers in their search strings and identifying articles that may be of later interested for detailed review.  Articles included in the CER need not all be large randomly controlled studies.  Simple cases studies and series can reveal details of technique and the details of adverse effects that are often lost in summary tables or never covered in the reports of large studies.

If a clinical investigation is anticipated, adverse events and risks need to be understood in drafting the protocol and its associated informed consent.

Start early, spread the work over the design cycle and take advantage of the efficiencies to be gained in running the CER in parallel with the design effort.

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.