Medical Device Notified Body Surprise Audits Required in 2014

L

Lucky57

#11
Re: Notified Body Surprise Audits Required in 2014

Is there any written regulation or directive in force, that we as manufacturer of class II products have to allow unannounced audits from our customer's NBs? Would appreciate any news regarding this. Thanks a lot.
 
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MIREGMGR

#12
Re: Notified Body Surprise Audits Required in 2014

Yes. If you (as the physical manufacturer of a medical device for which your customer is regulatorily responsible) refuse an unannounced inspection, your customer's NB is obligated starting this year to escalate the situation toward (if no resolution can be arranged) removing your customer's certification.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Re: Notified Body Surprise Audits Required in 2014

2. GENERAL GUIDELINES FOR AUDITS AND ASSESSMENTS
The notified bodies should apply the following:
(...)
(c) To verify the day-to-day compliance with legal obligations, notified bodies should, in addition to the initial, surveillance or renewal audits, visit the manufacturer or, if this is likely to ensure more efficient control, one of its subcontractors in charge of processes which are essential for ensuring compliance with legal requirements (‘critical subcontractor’) or a supplier of crucial components or of the entire devices (both: ‘crucial supplier’) without prior notice (‘unannounced audits’) in accordance with Annex III.
COMMISSION RECOMMENDATION on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU)

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

pkost

Trusted Information Resource
#14
Re: Notified Body Surprise Audits Required in 2014

I'm going to be pedantic, but I believe it is an important distinction

The directive/guidance/recommendation places no obligation on the sub contractors of manufacturers to undergo audits....HOWEVER....

The requirement comes from the manufacturers obligation to enable access to to their subcontractor for their notified body, the consequence of not enabling this is ultimately certificate revokation (as stated by MIREGMGR)...Therefore the manufacturer should be putting contracts in place with their sub contractors that essentially say that the subcontractor will permit the manufacturer, notified body AND competent authority on site to audit AND that this may be unannounced...Subcontractors will therefore have a contractual obligation to permit an NB unannounced audit

This clause would be a requirement of any business being placed on the subcontractor by the manufacturer....It may (and probably should state) that the subcontractor will have a similar right in place with any of their suppliers/subcontractors ad nauseam to the point of raw material supplier
 

Ronen E

Problem Solver
Staff member
Moderator
#15
Re: Notified Body Surprise Audits Required in 2014

I'm going to be pedantic, but I believe it is an important distinction

The directive/guidance/recommendation places no obligation on the sub contractors of manufacturers to undergo audits....HOWEVER....

The requirement comes from the manufacturers obligation to enable access to to their subcontractor for their notified body, the consequence of not enabling this is ultimately certificate revokation (as stated by MIREGMGR)...Therefore the manufacturer should be putting contracts in place with their sub contractors that essentially say that the subcontractor will permit the manufacturer, notified body AND competent authority on site to audit AND that this may be unannounced...Subcontractors will therefore have a contractual obligation to permit an NB unannounced audit

This clause would be a requirement of any business being placed on the subcontractor by the manufacturer....It may (and probably should state) that the subcontractor will have a similar right in place with any of their suppliers/subcontractors ad nauseam to the point of raw material supplier
I mostly agree but how did you conclude that the obligation goes beyond the 1st tier? In principal it makes sense but I doubt that NBs will take it that far, and I assume that even the Commission has some business sense to allow them to understand that this may be perceived as an unreasonable burden by 2nd or lower tier suppliers; and the last thing the Commission wants is to unduly disrupt business with EC impact. Either way, it's not spelled out in the Recommendation.

Cheers,
Ronen.
 
#16
Re: Notified Body Surprise Audits Required in 2014

My understanding is that the NB audit of suppliers only applies to critical suppliers, that is those suppliers that are named on your type examination certificate.

From my experience this would only have applied to the sterilisation provider when I was at an implant company - that was the only example I have seen of a supplier being named on the certification.

I believe that this information comes from a webinar delivered by a very senior NB supervisor.
 

pkost

Trusted Information Resource
#17
Re: Notified Body Surprise Audits Required in 2014

Not all notified bodies list suppliers on certificiates

Ronen: Critical supplier is the key term that could potentially allow/require audit back to raw material supplier, take for example orthopaedic implants, certainly the form and shape is critical, however the material, it's processing and consequential composition and microstructure are also critical. A manufacturers sub contractor may only machine down a bar received by a foundry,
 
#18
Re: Notified Body Surprise Audits Required in 2014

The listing of a supplier here is on the Type Examination Certificate, so only really applies to a Class III devices or AIMD.

The active implant company I previously worked for only had the sterilisation service suppliers listed - material suppliers (including silicones) were not classed as critical suppliers.

The company I now work for does various Class I and II products (including some sterile). With no Type Examination certificates involved we do not have any critical suppliers.
 

Ronen E

Problem Solver
Staff member
Moderator
#19
Re: Notified Body Surprise Audits Required in 2014

I understand the approach stated above, but I think it is a bit risky. The Commission recommendation has its definition of Critical Subcontractor, and it says nothing about them being the ones stated on a certificate. If this is based only on the opinion of a single NB specialist (as senior and knowledgeable as they may be), I'd look for something in writing or for second opinions or for some para-legal analysis of the Commission's wording, before concluding that if suppliers are not on certificates they will not be subject to unannounced audits.

Cheers,
Ronen.
 
#20
Re: Notified Body Surprise Audits Required in 2014

If this is based only on the opinion of a single NB specialist (as senior and knowledgeable as they may be)
The bloke in question is the current chair of NB-MED, the co-ordination board for Notified Bodies.

But, of course, the NBs and the EC do not always agree!
 
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