Medical Device Consulting Regulatory Quality Complaince

Annex 1 Requires an Overall Risk Benefit Analysis

What Does the MDD Say About a CER?

The MDD can be beautifully circumloquacious. Arrticle 3 of the MDD requires that all devices placed upon the market meet the requirements of Annex I.

Article 3
Essential requirements
The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.

Annex I provides the Essential Requirements the first 6 requirements of which are the General Requirements. For the text - click . Within this there is also the requirement that "Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X."  Annex X explicitly requires that the manufacturer "close the loop" by actively updating this clinical evaluation based upon ongoing monitoring of the postmarket performance of the device. For the text of the Annex X General Provisions - click . The Annex X General Requirements reference back to Requirements 1-3 & 6 of Annex I.

You cannot simply meet the requirements of Annex I by a simple review of the literature to meet the requirements for a CER.

Article 5 requires reference to applicable standards. It is Article 5 that requires compliance to standards such as ISO 13485, ISO 14971 and ISO 62366. Compliance with each of these standards requires the identification of harms/hazards associated with the device.  Demonstration of compliance with other design specific consensus standards answers the question of "is the design good enough" implied in responding to the requirements of Annex I (Both General and Specific) and Annex X.

The CER as an Overall Risk Benefit Analysis

Annex I can be summarized as a requirements to holistically prove the Risk-Benefit ratio of the device in question: prove it given your quality system,  given how it is designed, manufactured, packaged and transported and given its strengths/weaknesses as a therapy.  The efficient response to Annex I and Annex X is the write one document that is an overall risk benefit assessment.  To the standard, methodological, literature review, add:

• A summary of your quality system - the basis of the assumption that what you write can be trusted. This should include reference to your Design History File and to the consensus standards that apply to the device.

• A summary of the device's design and its intended use and target populations.

• A summary description of the physician or caregiver skill base and the institutional support requirements for the device - this supports your assessments per ISO 62366.

• A review of the design based major hazards and failure modes of the device to provide the framework by which your literature review section is read in .

• Summaries of your post market data - analyzed given the data from item 4.

• The results of your literature review

• A conclusion as to meeting the general requirements of Annex I and Annex X.

Your methodology for the literature search and processing of its results needs to be either a procedure with a summary of the results (search strings and hits - selection scores - tabular reports) as an appendix in each CER, or both a description of the process and the results summary attached as an appendix.