Do you have all your SOPs in place vis a vis 2013/473/EU

A little warning. Apparently at least one NB body is expecting procedures to be in place indicated in the Recommendation 2013/473/EU e.g. a procedure for classifying the device. If not in place then a CAR is raised.

Steve

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:253:0027:0035:EN:PDF

SteveK, thanks for this. Is this specifically referring to:

[Annex II] 9. Notified bodies should verify that the manufacturer’s procedures aiming at the fulfilment <sic> of procedural legal requirements, in particular with regard to determining the appropriate class and conformity assessment procedure, are up-to-date, complete, consistent and correct. These procedures should take account of the necessity to provide data in order to allow the notified bodies to respect their consultation obligations for certain devices referred to in Section 1 of Annex I.

(emphasis added)

(If not, can you point out the applicable clause(s)?)

Wouldn't the "procedure" just point to (or how to find) the applicable (and up-to-date) guidance?

My guess is that as this moves forward, another important expectation for a many-supplier company will be a procedure for categorizing the Approved Suppliers as to critical subcontractors and crucial suppliers on the one hand, and everyone else on the other, per Section 2(c); and a justification for however this ASL categorization is coordinated with the Significant Subcontractor list on the CE Certificate.

I assume the latter list is the resource from which the NB will determine an Unannounced Audit target, since they won't be asking the certificated company; but the certificate list is defined differently from Section 2(c) and, at least in our instance, is misleading if 2(c) is important.

yodon said:

SteveK, thanks for this. Is this specifically referring to:

[Annex II] 9. Notified bodies should verify that the manufacturer?s procedures aiming at the fulfilment <sic> of procedural legal requirements, in particular with regard to determining the appropriate class and conformity assessment procedure, are up-to-date, complete, consistent and correct. These procedures should take account of the necessity to provide data in order to allow the notified bodies to respect their consultation obligations for certain devices referred to in Section 1 of Annex I.

(emphasis added)

(If not, can you point out the applicable clause(s)?)

Wouldn't the "procedure" just point to (or how to find) the applicable (and up-to-date) guidance?

Click to expand...

Sorry about the late response, but yes. Also (if not already in place) the procedures listed in 10, 11 and 17 of Annex II. I know the guidance is in place (e.g. the MEDDEV), but apparently in the case I indicated a written procedure was still required. For those who subscribe this was raised in an article in Clinica.

Steve