Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down ... (32022R2346)
Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance)
- COMMISSION IMPLEMENTING REGULATION (EU) 2022/2346
- of 1 December 2022
- laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
- (Text with EEA relevance)
- Article 1
- Common specifications
- Article 2
- Transitional provisions
- Article 3
- Entry into force and date of application
- ANNEX I
- Scope
- Risk Management
- 2. General requirements
- 3. Risk management planning
- 4. Identification of hazards and risk analysis
- 5. Risk evaluation
- 6. Risk control and evaluation of residual risks
- 7. Risk management review
- 8. Production and post-production activities
- Information for safety
- 11. Label
- 12. Instructions for use
- ANNEX II
- Scope
- Risk management
- 3. Specific risks
- 4. Specific risk control measures
- Information for safety
- 5. Label
- 6. Instructions for use
- ANNEX III
- Scope
- Risk management
- 3. Specific risks
- 4. Specific risk control measures
- Information for safety
- 5. Label
- 6. Instructions for use
- ANNEX IV
- Scope
- Risk management
- 3. Specific risks
- 4. Specific risk control measures
- Information for safety
- 5. Label
- 6. Instructions for use
- ANNEX V
- Scope
- Definitions
- Risk management
- 4. Specific risks
- 5. Specific risk control measures
- Information for safety
- 6. Instruction for use
- ANNEX VI
- Scope
- Definitions
- Risk management
- 4. Specific risks
- 5. Specific risk control measures
- Information for safety
- 6. Instructions for use
- ANNEX VII
- Scope
- Risk management
- 3. Specific risks
- 4. Specific risk control measures
- Information for safety
- 7. Instructions for use
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