I'm working for a device company with 'a system' that has a range of 30+ attachments., supplied sterile. The system is a Class IIb device and the attachments are used singly as required by the clinician.
We are in the process of updating our technical file and creating a STED that addresses the requirements of Annex II of the MDR, Technical Documentation.
My question relates to the level of detail provided in the General Safety and Performance Requirements (GSPR).
Specifically considering section 4 d), which states, 'the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS.... etc etc.'
The precise identity of such controlled documents will be covered in full in other sections of the STED, for example within, 3. Design & manufacturing, 6. Preclinical and clinical data etc. As you can imagine for 30+ attachments to the system, this is quite a long list of documents
To avoid generating long lists of document references in the GSPR, would it be acceptable to cite the relevant section/s of the STED?
Thanks in advance for your thoughts and feedback.
We are in the process of updating our technical file and creating a STED that addresses the requirements of Annex II of the MDR, Technical Documentation.
My question relates to the level of detail provided in the General Safety and Performance Requirements (GSPR).
Specifically considering section 4 d), which states, 'the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS.... etc etc.'
The precise identity of such controlled documents will be covered in full in other sections of the STED, for example within, 3. Design & manufacturing, 6. Preclinical and clinical data etc. As you can imagine for 30+ attachments to the system, this is quite a long list of documents
To avoid generating long lists of document references in the GSPR, would it be acceptable to cite the relevant section/s of the STED?
Thanks in advance for your thoughts and feedback.
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