A (5) | B (1) | C (14) | D (2) | E (14) | F (4) | G (1) | H (1) | I (14) | J (1) | L (1) | M (4) | N (4) | O (1) | P (15) | Q (2) | R (2) | S (7) | T (2) | V (1)

Latest Glossary Definitions

CE-marking technical file

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.

CE Marking

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 Pathways

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.

Adverse Drug Reaction (ADR)

Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.

Foods for Special Medical Purpose (FSMP)

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.

Investigational Device Exemption (IDE)

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 meeting

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.

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