RAC Exam - EU MDD/AIMDD & MDR NEWEST ACTUAL EXAM COMPLETE 120 QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+

1 | P a g e 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) 2. Invasiveness 3. Energy Use (active, passive) 4. 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 2 | P a g e (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 2. resulting in serious deterioration in patient/user/other health 3. 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 3 | P a g e 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 2. affected customers 3. 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 - 1. already reported incidents 2. incidents usually exempt from reporting 3. events usually not reported