certi-22 Welcome to your certi-22 Name Email 1. When is a technical documentation necessary? Only for Class IIa – Class III devices For every medical device For every medical device, with the exception of devices intended for a clinical trial and custom-made devices None 2. Who is the owner and thus responsible to keep the Technical Documentation up to date? The manufacturer The consultant who helped creating the TD The distributor None 3. The device description of an implantable pacemaker is not referencing any similar devices, what would you do? A pacemaker is a very complicated and complex device, it is acceptable that there is no similar device as the device under assessment is very special A pacemaker is a very common device, not mentioning similar devices is not acceptable, I would write a deficiency What is a similar device? What is similar, I don’t know, I won’t do anything. None 4. Where can requirements for Technical Documentation on Post-Market Surveillance be found in the MDR? Annex I Annex IV Annex III None 5. The Technical Documentation of a medical devices includes information on the design stages applied by providing the Design & Development SOP, what do you think? Acceptable, the SOP is enough to understand the design stages Not acceptable, the SOP does not provide any information on the specific design stages of the device None 6. The instruction for use of a medical device is provided in English, the manufacturer claims. “The device shall be used by professionals all over Europe, all those professionals are able to read and understand English.” Is this acceptable? Yes, a physician who completed an education on an university is able to understand English. No, language requirements by each member state must be considered, English is not enough to cover all language requirements in all member states If there are no client complaints English should be sufficient. None 7. When is the requirement of demonstrating conformity with the provisions of Directive 2004/10/EC (GLP) applicable? Only when testing on CMR substances is performed When chemical testing is performed in routine production to prove compliance with product specifications When testing of chemical products to assess safety is performed All answers are correct None 8. When testing of a device to prove compliance with a requirement of regulation 2017/745 is performed according to a version of a standard that has been superseded: A Non-conformity should be issued against the requirement of regulation 2017/745 of taking into account the generally acknowledged state of the art (e.g. GSPR 1) A Non-conformity should be issued against the clauses of the up-to-date standards that have not been applied Non-conformity should be issued even if a gap analysis between the standard editions has been performed and adequate evidences are available addressing any gaps All answers are correct None 9. Technical documentation must include: PMS plan, PMCF plan, any available PSUR for Class IIa, class IIb and class III devices PMS plan and PMS report only for Class IIb and class III devices PMS plan and any available PSUR only for Class IIb and class III devices None of the answers are correct None 10. All known and foreseeable risks related to a device: Must be reduced as far as possible Must be reduced as far as possible even when they are scored as acceptable without any control measures Must be reduced as far as possible without adversely affecting the benefit-risk ratio All answers are correct None 11. The demonstration of compliance with every applicable GSPR: Should be provided in the form a checklist Should be demonstrated by providing a test report for every applicable GSPR Must include an adequate explanation for GSPR that are considered non applicable All answers are correct None 12. For every verification / validation /test or study that is performed, the technical documentation should include: design/protocol, methods of analysis, data summaries, results of analysis, and conclusions design/protocol, result summary, and conclusions methods of analysis, data summaries, results of analysis and conclusions design/protocol, methods of analysis, results of analysis None 13. Evidences related to the validation of methods of elimination or inactivation of viruses are required for: Devices manufactured utilising tissue and cells of human origin or their derivatives Devices manufactured utilising tissue and cells of animal origin or their derivatives Devices manufactured utilising tissue and cells of microbial origin or their derivatives All answers are correct None 14. Which of these devices cannot be sampled? Class IIa non-implantable devices Class IIa implantable devices Class IIb non-implantable devices Class IIb implantable devices Class IIb active devices intended to administer and/or remove a medicinal product None 15. Which of these statements about sampling of technical documentation is false according to MDCG 2019-13? The notified body shall draw up and keep up to date a sampling plan At least one technical documentation assessment each year 25% of devices from each category/generic device group over certification cycle A minimum of 5% for the first certification cycle under the MDR If very few devices and these have been already reviewed, focus of surveillance audits can be on post-market surveillance data None 16. Which of these statements about the sampling of technical documentation is false? It isn’t feasible to read every page Verify how the manufacturer evaluates, plans, executes and presents the evidence You don’t need to verify all requirements for a standard Use risk-based approach to select least critical requirements for given product/process If there is a lot of supporting evidence, chose the records with bigger impact on the product/process or performance/safety None 17. Which of these statements about the technical document assessment is true? Same time spent for all classifications Same depth for all classifications including Class I reusable devices Same depth for Class IIa/IIb/III devices Depth is greater for Class III and Class IIb implantable devices Depth is greater for Class IIb devices than Class IIa devices None 18. Which of these statements about the purpose when documenting your assessment of the technical documentation is false? To demonstrate that the technical documentation meets or does not meet the relevant regulatory requirements To provide an audit trail to relevant documentation To show that there were gaps in the assessment To demonstrate that you have the necessary competence to undertake the assessment To serve as a template from which required assessment reports can be extracted None 19. Which of these is not a type of question? Open Closed Probing Survey Leading None 20. Which of these is not part of a non-conformity? Category Statement of non-conformance Clause requirements Objective evidence Root cause None Time's up pascaleperspectives2025-02-20T23:01:30+01:00
