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RAC Exam - EU MDD/AIMDD & MDR NEWEST 2024-
2025 ACTUAL EXAM COMPLETE 120 QUESTIONS
AND CORRECT DETAILED ANSWERS ( VERIFIED
ANSWERS) |ALREADY GRADED A+
If a device is intended to have a biological effect or is absorbed, how does this affect classification? - ANSWER- Push it in to a higher class
What are the 4 key classification concepts? - ANSWER- 1.Time Period (Transient, short/long term)
- Invasiveness
- Energy Use (active, passive)
- Biological activity (absorbable)
Integrating a drug into a medical device for ancillary purposes results most often in what classification? - ANSWER- Class III
A container is regulated as a specimen receptacle of its intended mainly to - - ANSWER- come in direct contact with the specimen, which could then affect the specimen
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(IVDs) Before signing the DoC and affixing a CE Mark a mfgr must ensure its product meets - - ANSWER- the Essential Requirements of IVDD or GSPRs of IVDR Annex 1
What is EN ISO 980 for? - ANSWER- Harmonized symbols
Mfrs are advised to have a combination of ---- and ---- strategies for managing risks throughout the product life cycle - ANSWER- proactive and reactive
Why is PMCF needed? - ANSWER- premarket data do not necessarily enable mfr to detect infrequent complications or problems apparent only after widespread or long term use
What are the 3 types of incidents that must be reported to the CAs? - ANSWER- 1. resulting in death of patient, user or other
- resulting in serious deterioration in patient/user/other health
- may have led to death/serious injury but did not due to
healthcare intervention or fortune
In general, where should the incident report be made? - ANSWER- To the CA in the country where the incident occurred. Sometimes country specific directives require mfrs to 2 / 3
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in inform the member state CA when performing an action in response to an incidence within a member state territory
In the event of an incidence, what is vital to providing reliable info on particular devices or batch locations and state of use. - ANSWER- Traceability - the ability to trace a medical devices distribution
What is an FSCA also referred to as? - ANSWER- (Field Safety Corrective Action) aka Recall or withdrawal
When an FSCA is implemented the mfr must send copies of the FSN to - - ANSWER- 1. CA's in countries where FSCA is performed
- affected customers
- If NB involved for conformity assessment, FSN should also
be sent to CA in member state where NB is located
When should a trend report be submitted? - ANSWER- If there is a significant increase in -
- already reported incidents
- incidents usually exempt from reporting
- events usually not reported
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