Europe

Currently medical devices and in-vitro diagnostics are not subject to any pre-market authorisation in Europe but to a conformity assessment. Based on the complexity of the product and the risk associated with its use, the conformity can either be declared by the manufacture (for low-risk products) or a notified body is involved in the conformity assessment (for medium- and high-risk products). In case the principle intended action of a medical device is supported by including an active substance, a competent authority will be involved in the assessment of the usefulness of incorporation of the substance into the device.

Once certified, devices bear the CE marking which allows them to circulate freely in the EU/EFTA countries and Turkey. Currently proposals for two EU-Regulations dealing with medical devices and in-vitro diagnostics are under discussion. Based on these proposals a pre-market authorisation might be required for high-risk medical devices in the future. Furthermore, the current proposal foresees that all medical devices and in-vitro diagnostics certified and marketed at present will need to perform a new conformity assessment.