Medical Device Consulting Regulatory Quality Complaince

Its the Therapy that Matters

Annex I of the MDD states, in the general requirements, that you have to consider the risk-benefit of the device given how you design it, manufacture, label, package and transport it.  The FDA and the EU have a current clinical practice framework.

Consider the device THERAPY not just the device.

The therapy has complications and side-effects that are not related to device failures but to the use of the device when it is functioning normally, or when it is implanted, or when it is removed.  All these aspects of the therapy have to be considered.  Care givers are not perfect.  They make mistakes.  The predicable level of iaterogenic morbidity and mortality are also part of the assessment of "Risk-Benefit".

Patients have choices.  They can choose between alternative therapies and even decide not to treat a disease state at all.

In considering the Risk-Benefit o YOUR device; you have to consider this in relation to the NO THERAPY state, ALTERNATIVE therapies and alternative SIMILAR devices given the health state of the target patient. 

As an example, the mortality from unrepaired aortic aneurysm is 80-100% if rupture occurs, the mortality from elective open repair is 5% and the morality from elective endovascular repair less than 2% but the morbidity over time is higher than for surgical repair. 

If you are a 50'ish male with Marfan's Syndrome in otherwise good health your therapy choice might be different than those of an hypertensive 55 year old chronic smoker with Class I diabetes and metastatic lung disease.

Your Design History File and your labeling define your target patient population. Broad indications are attractive to Sales Teams. However, Notified Bodies and Regulatory Agencies such as the FDA, TGA Health Canada and the PMDA are all requiring that you define a specific patient populations and provide focused indications.  Your CER supports your decisions as to these two factors. 

These factors are part of the input documentation for your device - hence your CER has to begin its life at the start of your product development cycle.