RAC Exam Prep - EU MDD-AIMDD MDR Latest

RAC Exam Prep - EU MDD-AIMDD & MDR Latest Updated - ual 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

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