Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list... (32017R2185)
Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. )
- COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185
- of 23 November 2017
- on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
- (Text with EEA relevance)
- Article 1
- List of codes
- Article 2
- Application for designation
- Article 3
- Entry into force
- ANNEX I
- The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745
- I.
- CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
- A.
- Active devices
- 1.
- Active implantable devices
- 2.
- Active non-implantable devices for imaging, monitoring and/or diagnosis
- 3.
- Active non-implantable therapeutic devices and general active non-implantable devices
- B.
- Non-active devices
- 1.
- Non-active implants and long term surgically invasive devices
- 2.
- Non-active non-implantable devices
- II.
- HORIZONTAL CODES
- 1.
- Devices with specific characteristics
- 2.
- Devices for which specific technologies or processes are used
- ANNEX II
- The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of
- in vitro
- diagnostic medical devices under Regulation (EU) 2017/746
- I.
- CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
- 1.
- Devices intended to be used for blood grouping
- 2.
- Devices intended to be used for tissue typing
- 3.
- Devices intended to be used for markers of cancer and non-malignant tumours
- 4.
- Devices intended to be used for human genetic testing
- 5.
- Devices intended to be used to determine markers of infections/immune status
- 6.
- Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures
- 7.
- Devices which are controls without a quantitative or qualitative assigned value
- 8.
- Class A devices in sterile condition
- II.
- HORIZONTAL CODES
- 1.
- In vitro diagnostic devices with specific characteristics
- 2.
- In vitro diagnostic devices for which specific technologies are used
- 3.
- In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verification
- 4.
- In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification
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