Common Specifications versus Harmonized Standards

[Alyssa]

Hello all,

This may be an obvious question but I need a tiebreaker. We're undergoing our internal audit right now and the auditor just brought up a potential issue with our DoC as it doesn't list any Common Specifications. To my knowledge, there are none for our device, however the auditor stated that the harmonized standards are considered common specifications. What's your take on this?

 

[Raisin picker]

MDR Article 2 (71), emphasis by me:

‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

Article 9 elaborates on this:

... where no harmonised standards exist or where relevant harmonised standards are not sufficient, ...

The auditor is clearly wrong. Although, CS have a role similar to harmonized standards, they are not standards themselves.

 

[Junn1992]

Just list all the standards used for the device, which includes ISO 13485, ISO 14971 etc etc.

Even if 60601 series does not apply to your device, then just list whatever else applies

 

[Billy Milly]

13485 is not a product standard...