This is the most common conformity route used and makes the most sense for those organizations that have registered quality systems. The manufacturer must inform the notified body that approved the quality system of any planned substantial changes to its quality system. Changes to the design must be approved by the notified body. The manufacturer is required to maintain its declaration of conformity for at least five years after the last product has been manufactured. This conformity assessment route requires the notified body to test and evaluate a representative sample of the device to ensure that the device fully complies with the MDD's applicable requirements and the appropriate technical standards.
Compliance is based on examinations and tests performed by the notified body.
The notified body may, at its discretion, evaluate 100 percent of the devices or use rational statistical sampling methods. If there is a trend of frequent batch rejection, the notified body may ultimately suspend the statistical verification process and revert to 100-percent examination and testing. Sampling and statistical control of product is based on attribute testing, requiring a sampling system that ensures a limited quality corresponding to a probability of acceptance of 5 percent, with a nonconformity percentage of between 3 percent and 7 percent. EC Declaration of Conformity Compliance with this assessment route requires that the manufacturer of the medical device prepare the appropriate technical documentation to demonstrate full compliance with the requirements of the directive and associated technical standards. The processes and procedures defined in Annex VIII apply to custom-made devices or devices designed for clinical investigation.