RAC devices EU Exam Q&A Latest Update 2025
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RAC
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RAC
RAC devices EU Exam Q&A Latest Update 2025
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| Uploaded on: | April 28, 2025 |
| Last updated: | May 3, 2025 |
| Number of pages: | 13 |
| Written in: | 2025/2026 |
| Type: | Exam (elaborations) |
| Contains: | Questions & Answers |
| Tags: | RAC devices EU Exam Q&A Latest Update 2025 |
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RAC devices EU | Q&A Latest 2025/2026 | 100% PASS regulations - Answer -legally binding and directly enforceable directives - Answer -legally binding but just be transposed into national law each country can decide how they want to implement medical device directive (MDD) - Answer -directive 93/42/EEC includes essential requirements for safety but not technical specs where are technical specifications located? - Answer -standards products manufactured in line with standards are assumed to meet essential requirements list of harmonized standards punished in the official journal in vitro diagnostoc device directive (IVDD) - Answer -directive 98/79/EC essential requirements - Answer -safety requirements that devices must meet
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