SK13485
MedDev QA/RA
Hi,
May I know, if literature alone can be used for the preparing the Clinical Evaluation Report of a Class-IIb device? How stringent are the NB's requirements on the CER's?
I'd appreciate if somebody could clarify me the right guidance documents that can be used for the clinical evaluation SOP for EU, Canada, and the US.
The documents that I have are:
1)IMDRF/GHTF-SG5-N2R8-2007-Clinical Evaluation Final Document
2)Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data
3)MEDDEV 2.7.1/4 (For EU)
4)Guidelines on Clinical Investigation 2.7/4 December 2010
Our products are non-investigational devices. May I know, if there is any Clinical Evaluation guidance document that needs to be followed for US and Canada?
It would be great to hear some of your experiences with the auditors regarding the same. Your response in this regard shall be very helpful. Thank you.
Cheers
SK13485
May I know, if literature alone can be used for the preparing the Clinical Evaluation Report of a Class-IIb device? How stringent are the NB's requirements on the CER's?
I'd appreciate if somebody could clarify me the right guidance documents that can be used for the clinical evaluation SOP for EU, Canada, and the US.
The documents that I have are:
1)IMDRF/GHTF-SG5-N2R8-2007-Clinical Evaluation Final Document
2)Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data
3)MEDDEV 2.7.1/4 (For EU)
4)Guidelines on Clinical Investigation 2.7/4 December 2010
Our products are non-investigational devices. May I know, if there is any Clinical Evaluation guidance document that needs to be followed for US and Canada?
It would be great to hear some of your experiences with the auditors regarding the same. Your response in this regard shall be very helpful. Thank you.
Cheers
SK13485