INHALT

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