IMDRF : a) A general description of the device, including:
i. A statement of the device name
ii. What the device does?
iii. Who uses it and for what? (high level statement)
iv. Where to use it? (places/environment where the device is intended to be used)
v. How it works? Including theory surrounding feature/variants/operating modes that enable the device to be used for indications/intended use (principle of operation/mechanism of action).
vi. If applicable, labelled pictorial representation (diagrams, photos, drawings).
vii. If system, how the components relate?
viii. If applicable, identify if the device incorporates software/firmware and its role
b) Product specification, including:
i. Physical characteristics or relevance to the end user (dimensions, weight)
ii. Features and operating modes
iii. Input specifications (e.g. electrical power requirements, settings and associated allowable ranges/limits)
iv. Output and performance characteristics (e.g. range and type of energy delivered, resolution of images)
v. If applicable, an indication of the variants/models of the devices and a summary of the differences in specifications of the variants (comparison table and/or pictures/diagrams with supporting text).
c) Engineering diagrams/prints/schematics of the device.
d) List of accessories intended to be used in combination with the devices.
e) Indication of any other medical devices or general product intended to be used in combination with the medical device (e.g. infusion sets and infusion pumps, bipolar electrode and RF equipment).
f) Components or accessories that can be sold separately should be identified.
g) If approved by the regulator, provide the approval number and identification for each component or accessory.
h) If the device is to be sterilized, an indication of who is to perform the sterilization and by what method (e.g. EtO, gamma irradiation, dry heat) OR an affirmative statement that the device is non-sterile when used.
NOTE: The
validation report is not expected be presented at this point, only the device sterility condition shall be indicated here. If appropriate, for the validation report, see Chapter 3 – Non-Clinical Studies.
i) Summary of the composition of the device including, at minimum, the material specification and/or chemical composition of the materials that have direct or indirect contact with the user and/or patient. When required, full details to support how these specifications are met are to be provided in CH3.5.02 – Chemical/Material Characterization.
NOTE: If applicable, chemicals may be identified using either the IUPAC (International Union of Pure and Applied Chemistry) or the CAS (Chemical Abstract Service) Registry number. Reference to applicable material standards may also be useful in this description.
j) If applicable, indication of biological material or derivate used in the medical device, including: origin (human, animal, recombinant or fermentation products or any other biological material), source (e.g. blood, bone, heart, any other tissue or cells), and the intended reason for its presence and, if applicable, its primary mode of action.
k) If the device contains an active pharmaceutical ingredient (API) or drug, an indication of the
substance, should be provided. This should include its identity and source, and the intended reason for its presence and its primary mode of action.
NOTE: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the comprehensive device description and principles of operations provided in this section regarding the subject device
DT UE : a) et une description générale du dispositif,
d) Les principes de fonctionnement du dispositif et son mode d’action, démontré scientifiquement si nécessaire;
i) Une description ou la liste complète des différentes configurations ou variantes du dispositif qui doivent être mises à disposition sur le marché;
f) La classe de
risque du dispositif et la justification de la ou des règles de classification appliquées conformément à l’annexe VIII;
e) Les raisons pour lesquelles le produit constitue un
dispositif médical;
g) Une explication de toute caractéristique innovante;
h) Une description des accessoires de dispositif
h) Une description des autres dispositifs et des produits autres que des dispositifs destinés à être utilisés en combinaison avec le dispositif;
j) Une description générale des éléments fonctionnels clés tels que les pièces ou composants