MDD or other EU guidance that describes the need for Valid Production Processes


Involved In Discussions
Could someone point me to specific content in either the MDD or other EU guidance that describes the need for valid production processes. I am aware of the 13485 and CFR texts on this matter but I am struggling to find something specific from the MDD/MEDDEV type sources.


Super Moderator
Re: Valid production processes


Except for sterilisation*), validation of manufacturing processes is not specifically spelled out in the MDD. However, the essential requirements listed in Annex I, and especially section II, Requirements regarding design and construction, imply that you have established validated manufacturing processes.


*) MDD, Annex I,
8.4 Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method.


Involved In Discussions
Look also into the requirements of Annex II (or V). On several places reference is made to control various processes. Any process shall be assessed on hazards and risks for the patient/user (ER 1-4). And validation of processes can be used as evidence of control of processes or steps thereoff. Other options are 100% QC inspection (or sampling based on AQL etc).
Look into the former GHTF documentation on process validation for terminology and methodology.

Technically, validation is only mentioned in regard to sterilization, software, and virus elimination.

But: you are not going to win this fight with your Notified Body ;)
Top Bottom