A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.
Latest Glossary Definitions
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).
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.
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.
The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the 2010 pharmacovigilance legislation.
An Individual Case Study Report is an adverse event report for an individual patient.
These are specially formulated foods that provide partial or complete nutrient requirements for post-operative convalescing patients or other nutritionally vulnerable subjects with specific medically determined dietary requirements, which may not be adequately met by consuming normal diets.
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.
Innovation meetings are held by major EU Member States Competent Authorities (CA) to help organizations that are developing innovative medical devices (or using novel manufacturing processes) navigate the regulatory processes so they can progress their technologies.