Technical File / Design Dossier Exam

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Please answer the following questions by checking the appropriate box or by filling in the blank. This exam is open book, open notes, and a copy of the following guidance documents:

  • GHTF SG1/N011:2008(
  • NB-MED 2.5.1/Rec5 rev 4 (
  • NB-MED/2.5.2/Rec2 rev 7 (

You may also want to consult the M5 Version of 93/42/EEC” ( and the proposed regulations released by the EU Commission in 2012 ( A passing score is 14 out of 20 questions correct. Completed exams should be emailed to .

  1. Which risk classification of medical devices require a Technical File for CE Marking?
  1. Class I
  2. Class IIa
  3. Class IIb
  4. Class III
  5. A, B & C
  6. B, C & D
  7. None of the above
  1. Which risk classification of medical devices require a Design Dossier for CE Marking?
  1. Class I
  2. Class IIa
  3. Class IIb
  4. Class III
  5. A, B & C
  6. B, C & D
  7. None of the above
  1. ISO 13485 Certification is the only required Notified Body certification for CE Marking?
  2. True
  3. False
  4. Which guidance document should you follow in the future for preparing a Technical File?
  1. NB-MED 2.5.1/rec 5
  2. GHTF SG1/N011:2008
  1. What is a “STED”?
  2. Identify the most common conformity assessment procedure for each risk class (1 point each):
  1. Class I (non-sterile / non-measuring)
  2. Class I (sterile / measuring)
  3. Class IIa
  4. Class IIb
  5. Class III
  1. Which orthopedic device is expected to be reclassified from Class IIb to Class III when the new EU Regulations are approved?
  2. List three significant differences between a device that is a Class IIb with an Annex II CE Certificate and a Class III device with an Annex II CE Certificate (1 point each):
  3. Which tool is recommended to streamline the technical review for several Class III products that utilize the same technology?
  4. Technical File Index
  5. Manufacturing Process Flow Chart
  6. Master File
  7. None of the above
  8. Which acronym is referring to a labeling requirement in Annex III of the proposed European Regulations?
  9. CTS
  10. IEC
  11. EEC
  12. UDI
  13. How many Essential Requirements are in each of the following documents (disregard sub-parts; 1 point each)?
  14. M5 MDD (i.e., 93/42/EEC as modified by 2007/47/EC)
  15. Proposed EU Medical Device Regulations
  16. In which Annex and section of that Annex can you find the requirement for PMCF in the M5 MDD (i.e., 93/42/EEC as modified by 2007/47/EC)?
  17. Which of the following documents should be updated if there is a significant design change prior to submission of technical documentation to the Notified Body?
  18. Input-Output-Verification-Validation (IOVV) Matrix
  19. Product Development Plan
  20. Risk Management (RM) Plan, RM Report, Hazard Identification & Risk Analysis
  21. All of the above
  22. None of the above
  23. Bonus Question: In which section of Annex II can you find the requirement for PMCF in the propose EU Regulations?

Technical File & Design Dossier Requirements