Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.
Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
Latest Glossary Definitions
Adaptive pathway seeks to maximize the positive impact of new drugs on public health by balancing timely access for patients, with the need to provide adequate evolving information on benefits and risks.
CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable Medical Device Directives (including for In Vitro Diagnostic Device IVD and Active Implantable Medical Device AIMD).
The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class III. De novo process allows these low risk devices to be re-classified via a request for a risk-based (re)classification from the FDA.
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.
Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.
The FDA is a Federal agency within US Department of Health and Human Services, which is the primary regulating body of Food and Drug substances in the USA.
A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.
A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action
Approval of an Investigational Device Exemption (IDE) submission must occur by the FDA before a manufacturer can begin a (moderate to high risk) clinical investigation of its medical device in the US.