Annex I - General Safety and Performance Requirements. Precise identity - how provided

MiamiDM

Starting to get Involved
#1
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.
 
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s27bax

Starting to get Involved
#2
This phasing is used quite a lot in the MDR:
"The technical documentation and, if applicable, the summary there of to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. "

The above and your quote from section 4d would strongly suggest that the GSPR document should reference the precise identity of the document. I think the intention of the GSPR is to act as a summary which demonstrates conformance to key areas of the MDR.

Is your STED controlled by your QMS? If not, it is not possible to reference sections as they would not be controlled documents.

Based on the above, I would lean towards referencing the full file name of the controlled documents which demonstrate compliance to the relevant GSPR section.

Hope that helps
 

MiamiDM

Starting to get Involved
#4
Thank you for these thoughts.

Yes, the STED would be controlled by the QMS.

Surely if the GSPR is included in the STED - under section 4, and the other sections of the STED cover the required level of detail, e.g. doc. references, one could say that the information is there and close at hand.



This phasing is used quite a lot in the MDR:
"The technical documentation and, if applicable, the summary there of to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. "

The above and your quote from section 4d would strongly suggest that the GSPR document should reference the precise identity of the document. I think the intention of the GSPR is to act as a summary which demonstrates conformance to key areas of the MDR.

Is your STED controlled by your QMS? If not, it is not possible to reference sections as they would not be controlled documents.

Based on the above, I would lean towards referencing the full file name of the controlled documents which demonstrate compliance to the relevant GSPR section.

Hope that helps
 

s27bax

Starting to get Involved
#6
I went to a TUV conference back in August and they seemed quite keen to make the point that documents should be referenced in full and this is likely the course of action that we will follow. Though it will only become clear how strict they are when it comes to audit. It will be mean a tech file update when a document is revised, which has prompted a thorough review of how we handle tech file updates to make sure it can be handled as quickly as possible.
 

MiamiDM

Starting to get Involved
#7
I went to a TUV conference back in August and they seemed quite keen to make the point that documents should be referenced in full and this is likely the course of action that we will follow. Though it will only become clear how strict they are when it comes to audit. It will be mean a tech file update when a document is revised, which has prompted a thorough review of how we handle tech file updates to make sure it can be handled as quickly as possible.
Many thanks
 
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