Professional Documents
Culture Documents
3.1 Investigational Medical Device
3.1 Investigational Medical Device
Implantable System
Yes No
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3.1.4 Device Identifiers
Generic denomination:
Device name:
Classification rule:
Rule 1 - non invasive device and no other rules can be applied
Rule 2 - Channelling or storing blood, liquids, cells or tissues, liquids or gases for eventual administration or introduction in the body
Rule 3 – Non-invasive devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or
Rule 4 - Non-invasive devices which come into contact with injured skin oe mucous membrane
Rule 5 - Invasive devices with respect to body orifices, other than surgically invasive devices
Rule 6 - Surgically invasive devices intended for transient use (< 60 minutes)
Rule 7 - Surgically invasive devices intended for short-term use (>60 minutes, <30 days)
Rule 8 - Implantable devices and long-term surgically invasive devices (> 30 days)
Device description:
Yes No
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Is the Investigational Device CE marked?
Yes No
To what extent is the intended purpose of the device in the clinical investigation covered by the CE‐mark?
CE marked device will be used within the scope of its CE mark and no additional procedures are
foreseen in the clinical investigation
CE marked device will used within the scope of its CE mark, but additional procedures are foreseen in
the clinical investigation
Yes No
Has this device been investigated in a clinical investigation within the EU previously?
Yes No
If yes, please provide the relevant reference number(s) (such as SIN, CIV-ID, other reference(s)) of the previous
clinical investigations
Has the investigational/study device been subject to a national scientific view/opinion from an Expert Panel
Yes No
Yes No
If no, please fill in the requested information in section 3.4.1 and 3.4.2.
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3.4.1 Manufacturer information
Organisation name:
Country:
Belgium
Telephone number:
Email:
First name:
Last name:
Telephone number:
Email:
Organisation name:
Country:
Belgium
Telephone number:
Email:
First name:
Last name:
Telephone number:
Email:
Additional devices could be added by using a duplicated section 3, in appendix to this application form.
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