Commission Decision (EU) 2018/1617 of 25 October 2018 concerning a measure adopte... (32018D1617)
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Commission Decision (EU) 2018/1617 of 25 October 2018 concerning a measure adopted by France pursuant to Council Directive 93/42/EEC with regard to the Terrafor and Defiligne medical devices (notified under document C(2018) 6943) (Text with EEA relevance.)
- COMMISSION DECISION (EU) 2018/1617
- of 25 October 2018
- concerning a measure adopted by France pursuant to Council Directive 93/42/EEC with regard to the Terrafor and Defiligne medical devices
- (notified under document C(2018) 6943)
- (Text with EEA relevance)
- 1.
- PROCEDURE
- 2.
- EXAMINATION OF THE JUSTIFICATION FOR THE MEASURE
- 2.1.
- Failure to comply with essential requirements
- 2.1.1.
- Essential requirements concerning the risk/benefit ratio
- 2.1.2.
- Essential requirements relating to minimising risk
- 2.1.3.
- Objections raised by the manufacturer concerning failure to comply with essential requirements
- 2.2.
- Incorrect application of standards
- 2.3.
- Conclusion
- Article 1
- Article 2
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