Annex II - Technical Documentation. V&V, Performance and Safety

MiamiDM

Starting to get Involved
#1
I'm part of a team in the process of generating a STED covering the Technical Documentation (for a longstanding Class IIb device) in accordance with Annnex II of the MDR.

Within section 6 of Annex II, 'Product Verification and Validation', the final subsection of 6.1b) is titled 'Performance and Safety'.

Having already completed the preceding sections of 6.1, covering preclinical and bench testing, biocompatibility/chemical/micro characterisation, electrical safety etc, I think 'Performance and Safety' is very well covered already.

Do you have any advice as to what is expected under the 'Performance and Safety' subsection?

Many thanks
 
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Marcelo

Inactive Registered Visitor
#2
The previous bullets are related to specific testing, including some safety testing (biological evaluation, electrical safety, etc.). The last one os related to performance requirements (the old essential requirement 3 in the MDD, now the General requirement 1 -
"Devices shall achieve the performance intended by their manufacturer" in the MDR), and safety in general (for example, any other safety testing besides the ones mentioned in the previous bullets, including any overall safety verification).
 

MiamiDM

Starting to get Involved
#3
Thank you Marcelo - appreciated.

Prior to the sub section titled Performance and Safety, aside the various data requested in this section, we've already included data from preclinical and clinical testing (in section 6.1a) - which I see as validating the 'performance intended by the manufacturer'.

Other than an 'Executive summary/statement' covering what has already been provided elsewhere in the STED, e.g section 3, Design and Manufacturing and section 5, Risk, I can't see what else can be included under Performance and Safety.

Please do correct me if I'm missing something obvious here :)
 

Marcelo

Inactive Registered Visitor
#4
Performance intended by the manufacturer refers to the explicit performance required defined under the "Performance"General Principle in the device design process. So you have to clearly link them. "Preclinical and clinical testing" may include them, but unless they are explicit linked, they don't.

As I mentioned before, the bullet examples in 6.1 b) cover some examples of safety testing, but non of performance testing. So if you have performed performance testing and any other safety testing besides the bullets points (clearly linking them with the specific requirements from device design and General Requirements), you should put them there.
 
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