RAC Exam Prep - EU MDD-AIMDD & MDR Latest Updated 2024-2025 Actual Exam 150 Questions and 100% Verified Correct Answers Guaranteed A+
"New Approach" principles of tech harmonization and standards refers to the directive that medical device design and manf are subject to ... - CORRECT ANSWER: Essential requirements
(IVDs) Before signing the DoC and affixing a CE Mark a mfgr must ensure its product
meets - - CORRECT ANSWER: the Essential Requirements of IVDD or GSPRs of IVDR
Annex 1
90/385/EEC - CORRECT ANSWER: Active Implantable Medical Devices Directive
(AIMD)
93/42/EEC - CORRECT ANSWER: Medical Device Directive (MDD)
98/79/EC - CORRECT ANSWER: In vitro Diagnostics directive (IVDD)
A clinical evaluation is required for - - CORRECT ANSWER: every device, Class I
through III under all directives
A container is regulated as a specimen receptacle of its intended mainly to - - CORRECT ANSWER: come in direct contact with the specimen, which could then affect the specimen
A material is considered to have a biological effect if it actively and intentionally ---- -
CORRECT ANSWER: induces, alters, or prevents a response from tissues that is
mediated by specific reactions at a molecular level
A notified body will not get involved in _______ device unless it is sterile or has _____ -
CORRECT ANSWER: Class I,, measuring function
A recommend way to comply with MDD requirements is using ___ ____ standards -
CORRECT ANSWER: EU harmoized
All ----- contributing to the intended purpose must be considered - CORRECT
ANSWER: Modes of action
CIR - CORRECT ANSWER: Clinical Investigation report
Clinical trials which may be conducted as part of the clinical evaluation process -
CORRECT ANSWER: Clinical investigation 1 / 2
Combination devices are most often classified as - CORRECT ANSWER: Class III
Custom Devices must comply with ____ and be manufactured under a ____ ____ ensuring the devices are manf'd in accordance with the device's ______ - CORRECT
ANSWER: Annex 1 Essential Requirements, quality system, description
Custom made device must fulfill the reqs set out in MDD _____ and may/may not bear
CE markings - CORRECT ANSWER: Annex VIII, may not
define 'intended purpose' - CORRECT ANSWER: the use for which the device is
intended according to the data supplied by the manf on/in labeling, instructions, promotional material
Define 'self testing' - CORRECT ANSWER: any device intended by the maf as used by lay persons
Define "putting in to service" - CORRECT ANSWER: the stage at which a device has been made available to the final user as being ready for the use on the Community market for the first time for its intended purpose
Define comparator device - CORRECT ANSWER: established device bearing a CE
Mark that is used as a reference in a clinical investigation NOT a predicate device like FDA)
Define EC type-examination - CORRECT ANSWER: NB body reviews and, at times,
performs device testing
Define horizontal/Level I standards - CORRECT ANSWER: General Standards relevant to all/wide range of product types
define implant - CORRECT ANSWER: any device intended to
- be introduced totally into the human body
- to replace epithelial surface or surface of eye
- be partially introduced into the body through surgical intervention and intended to
remain in place for at least 30 days
define Manufacturer - CORRECT ANSWER: natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market in his own name...
define Semi-horizontal/level 2 standards - CORRECT ANSWER: requirements
applicable to a range of similar products (surgical instruments)
Define short-term use - CORRECT ANSWER: between 60 minutes and 30 days
- / 2