Across
- 3. the current medical device regulation for the EU
- 4. a common abbreviation for quality management system
- 7. marking used for approved medical devices in the UK
- 9. the former medical device regulation for the EU
- 11. the swiss version of IVDR
- 13. the swiss version of MDR
- 14. the former IVD regulation for the EU
- 15. a common abbreviation for swiss authorized representative
- 17. the current IVD regulation for the EU
- 18. Who is responsible for drawing up a Declaration of Conformity
Down
- 1. a common abbreviation for European authorized representative
- 2. the swiss regulatory body
- 3. the UK regulatory body
- 5. the EU medical device database
- 6. If an authorized representative terminates the mandate with a manufacturer, within what timeframe do they need to inform the competent authority of the European Member State they are in
- 8. marking used for approved medical devices in the EU and Switzerland
- 10. a common abbreviation for declaration of conformity
- 12. used to test specimens outside of the human body
- 16. a common abbreviation for person responsible for regulatory compliance
- 19. a common abbreviation for UK responsible person