Glossary

AIMDD: Active Implantable Medical Devices Directive, which corresponds to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.

Authorised Representative: Legal entity established in the European Economic Area that performs the CE marking process in the name of a manufacturer established outside the EEA.

CE: European Conformity

CEN: European Committee for Standardization

Clinical Trial: any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other

pharmacodynamics effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.

Conformity Assessment Body: Body that performs one or several elements of conformity assessment, including one or several of

the following activities: calibration, testing, certification and inspection.

Declaration of Conformity (Doc): Written statement by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE.

Design Dossier: see Technical File

Directive: Legislative act that sets out a goal that all EU countries must achieve, although it is up to the individual countries to devise their own laws on how to reach this goals.

Distributor: Natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market.

DVT: Design Validation Tests

EEA: European Economic Area. Also known as European Market:

ESO: European Standardization Organization

EU-MDR: Medical Device Regulation. Which is: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

Harm: Physical injury or damage to the health of people, or damage to property, or the environment

Hazard: Potential sources of harm.

Importer: Natural or legal person established in the Union who places a product from a third country on the EU market.

ISO: International Organization for Standardization. Organization that develops and publishes International Standards.

IVDD: In vitro Devices Directive, which corresponds to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

QMS: Quality Management System can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.

Manufacturer: Any natural or legal person (established inside or outside the EEA) that manufactures a product or has a product designed, and places it on the market under his own name or trademark.

MDD: Medical Devices Directive, which corresponds to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

Medical Device: any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

Diagnosis, prevention, monitoring, treatment or alleviation of disease,
Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
Investigation, replacement or modification of the anatomy or of a physiological process,
Control of conceptions,

and which does not achieve its principal intended action in or on the human body by pharmaceutical, immunological or metabolic means, but which may be assisted in its function by such means.

Notified Body: Organization that has been accredited by a Member State to assess whether a product meets certain standards.

Product lifetime: considered as the time from manufacture until the device ceases to fulfil its intended use.

Regulation: binding legislative act and must therefore be applied in its entirety across the EU.

Risk: Combination of the probability of occurrence of harm and the severity of that harm

Shelf life: time the device can be kept in the packaging prior to use.

Technical File: documentation intended to provide information on the design, manufacture and operation of the product. Called Design Dossier for Class III devices.