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RAC Exam Prep - EU MDD/AIMDD & MDR 2023 with complete solution;(Study Aid - RAC)
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RAC Exam Prep - EU MDD/AIMDD & MDR 2023 with complete solution;(Study Aid - RAC)
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RAC Exam Prep - EU MDD/AIMDD & MDR 2023with complete solution;(Study Aid - RAC)
Similar but more detailed than the Essential Requirements - -General Safety
and Performance Requirements
-This ISO standard includes the most recent update to specific medical
device companies quality management system? - -13485:2016
-Which entity affixes it's identification number near the CE Mark? - -Notified
Body, if involved in the conformity assessment
-Un-classified devices not requiring CE mark - -Custom-made,
Investigational, Compassionate/Orphan
-All ----- contributing to the intended purpose must be considered - -Modes
of action
-Define transient use - -less than 60 minutes
-Define short-term use - -between 60 minutes and 30 days
-A material is considered to have a biological effect if it actively and
intentionally ---- - -induces, alters, or prevents a response from tissues that
is mediated by specific reactions at a molecular level
-refers to a material's degradation within the body and metabolic
elimination of the resulting degradation products from the body - -
Absorption
-Combination devices are most often classified as - -Class III
-MEDDEV 2.4/1^7 is a guidance for - -Classification under MDD
-Standalone software is considered what type of device - -Active
-Software that drives a device or influences its use automatically falls in to
which classification? - -That of the device
-If a manufacturer and an NB cannot agree on the classification who is
consulted for a solution? - -Competent Authority
-How can a manufacturer appeal the CA's decision of a classification? - -in
the national courts
, -Define horizontal/Level I standards - -General Standards relevant to
all/wide range of product types
-define Semi-horizontal/level 2 standards - -requirements applicable to a
range of similar products (surgical instruments)
-Define vertical/level 3 standards - -apply to a single product type or narrow
range of products
-Define comparator device - -established device bearing a CE Mark that is
used as a reference in a clinical investigation NOT a predicate device like
FDA)
-What is the ISO for biocompatibility? - -ISO 10993
-IEC 60601 regards - - -electrical safety and electric magnetic disturbance
-The amount of a medical device's testing is/should be commensurate with -
- -it's potential RISK to human health
-Name the two forms of clinical data used in CE marking - -1. compilation of
relevant scientific literature currently available on the device's intended
purpose, techniques employed and critical evaluation of the compilation
2. results and conclusions of a specifically designed clinical investigation
-What is contained in Annex 1 of the MDD, AIMDD and MDR? - -Essential
Requirements (GSPRs in MDR)
-A clinical evaluation is required for - - -every device, Class I through III
under all directives
-If the literature shows new or other risks what may need to be updated? - -
risk management plan
-What is not required if a manufacturer can collect clinical evidence from
literature? - -Clinical investigation
-State of the art = - -current generally accepted technology and
performance output not to be confused with top-of-the-line.
-FSCA - -Field Safety Corrective Action
-ISO 14155 - -Clinical investigations of medical devices in human subjects
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