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).
Latest Glossary Definitions
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.
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.
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.
Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.
The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.
The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as well as a large number of relevant regional agencies and non-for-profit organizations that produce or c
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.