Medical Device Notified Body Surprise Audits Required in 2014

[QA-Man]

I just read that as of January 1, 2014, European Law requires that all Notified Bodies must conduct unannounced audits at least once every three years. This change is in response to the high-profile Poly Implant Proth?se (PIP) breast implant scandal.

We only market a single CE marked basic IVD and plan to market a single class I CE marked device (non-sterile, no measuring). We don't even have an EC Certificate.

I hoping someone would have information that would indicate these surprise audits do not apply to us.

 

[Reg Morrison]

Re: Notified Body Surprise Audits Required in 2014

I hoping someone would have information that would indicate these surprise audits do not apply to us.

The technical term is "unannounced audits", and, I am sorry to say, it seems that EVERY manufacturer will be subjected to it.

From SGS:

Unannounced audits

All of the following points should be considered in relation to the new legislation:

a). Unannounced audits will be carried out in a random manner once in every three-year period on all manufacturers of medical devices of all classes. Manufacturers of high-risk devices and those that are frequently noncompliant will have this frequency increased to 18-month periods.

b). Manufacturers will have no prior notice and most audits will last one day and involve a team of two or more auditors.

c). As the main manufacturing site will normally be the location of the unannounced audit, this will in some instances be the location of the critical subcontractor and not the location of the (legal) manufacturer.

d). Unannounced audits will comprise two elements: a sample check to ensure recent or current production is in conformity with the technical documentation, meets specifications and that critical components and materials are traceable; and an audit of two critical processes as listed in f) above with the exclusion of software validation.

e). Testing of the chosen sample(s) will usually be required to establish conformity and this can be undertaken by the manufacturer and witnessed by the Notified Body during the audit, or the Notified Body may take away samples for subsequent test. For devices that do not require an EC design examination or type examination, one device will be taken. For high-risk devices, a minimum of three will be examined and tested. Sampling and testing procedures will have to be defined in advance and this is an area of the Recommendation that will need further clarification.

f). Unannounced audits and the accompanying testing represent the major additional direct cost to the manufacturer of these EU Commission changes. The additional cost will vary greatly from manufacturer to manufacturer but will in many cases increase certification costs over a three-year period by between 20% and 50%.

 

[pkost]

Re: Notified Body Surprise Audits Required in 2014

Reg's post is slightly inaccurate. Unannounced audits only apply to companies that have products approved by a notified body.

Therefore companies that only produce , MDD Class I, non measuring/non sterile
or
IVD, non listed, non self test

will not be subject to an unannounced audit from a notified body; because they don't have a notified body to audit them

 

[RobertvanBoxtel]

Re: Notified Body Surprise Audits Required in 2014

Technically, it is not even a regulation or directive, it is only a recommendation (213/473/EU) addressed to the Member States. That's because the EC does not have a direct control over the NB's, that control is at MS level.
Nevertheless, it identifies to the MS, how the EC expects that the NB's will have to operate during product assessment (Annex I), quality system assessment (Annex II) and Unannounced audits (Annex III).
The information provided in these Annexes mostly should be no surprises to MS's, NB's and even manufacturers as they are based on best practises already available in the EU.
Mind you, the MDD has always included the option of unannounced audits. Much more political pressure is applied now due to the PIP implant fraud and resulting DALI action plan. It has even resulted (personal interpretation) in TUV being fined in France for not having done all possible reviews within the settings of the MDD (=no unannounced audits).

So you can bet that all NB's (see SGS reaction) will be performing unannounced audits. There is a consensus that it will really kick off in March 2014, with an initial focus on High risk device manufacturers.

For Class I devices (or "other" IVD's), not falling under the NB responsibilities but with the MS MoH, the local inspectors of the MoH of the MS will perform inspections, with higher frequencies, also as a result of the DALI actionplan. In the Netherlands, we are already seeing this increase in inspections.

 

[MIREGMGR]

Re: Notified Body Surprise Audits Required in 2014

My employer is a US-based manufacturer applying the CE Mark under MDD to Class I and I-s devices. Our prominent MDD NB has said nothing to us to date about an annual cost increase and a procedure for such unannounced inspections.

"Unannounced" is fine, but if our NB shows up on a day when we have a scheduled major-customer audit in progress, or a visit from US FDA, we're necessarily going to give priority to that scheduled or legally obligatory activity and the NB auditor is going to have to make do with second-string responders and less convenient resources. Ditto if we have senior people out of the office on a supplier audit trip or other reason.

 

[MIREGMGR]

Re: Notified Body Surprise Audits Required in 2014

For Class I devices (or "other" IVD's), not falling under the NB responsibilities but with the MS MoH, the local inspectors of the MoH of the MS will perform inspections, with higher frequencies, also as a result of the DALI actionplan. In the Netherlands, we are already seeing this increase in inspections.

It's a bit of a gap in the EU system that outside-EU makers of devices in the above-referenced classes are not inspected at all under MDD.

US FDA inspections hardly count as a stand-in for the described EU inspection process. US FDA inspections are frequency-scheduled according to risk; my employer for instance has not been inspected since 2003--as far as I know, because of an undocumented risk-evaluation process by our regional office in which they determined they did not need to worry about us--and is not even on the inspection eligibility list (for QSIT 1/2, not For Cause) any more due to our having joined the Voluntary Audit Report Submission pilot program beginning in 2012. So our CE Marked Class I non-sterile devices are not supervised at all, other than (in theory) reactively in response to adverse event reports.

 

[RobertvanBoxtel]

Re: Notified Body Surprise Audits Required in 2014

Your US based employer with the Class I and Is devices will have a EU Authorized Representative. And they might very well be inspected as they have notified your devices to the MoH in the country where the EU AR is located. The inspector can go visit them and request to see the technical documentation that has been declared to be available conform Annex VII of the Medical Device Directive.
So you might not be audited for Class I devices, your EU AR can be audited. Furthermore, the Notified Body will make a risk assessment and starts auditing the high risks first. But somewhere along the line they might also step by unannounced at your facility.:
Not allowing them to enter can have an impact on your certification, see SGS information. It might be therefore worthwhile to consider leaving your customer and address the NB.
Having a plan / SOP available on handling NB's might be helpfull for this.

 

[MIREGMGR]

Re: Notified Body Surprise Audits Required in 2014

Furthermore, the Notified Body will make a risk assessment and starts auditing the high risks first. But somewhere along the line they might also step by unannounced at your facility.

I doubt if our MDD NB will be auditing our Class I (non sterile, non measuring) activity, as we have no contractural/business relationship with them in regard to that activity.

As to I-s activity, we interact frequently with our NB. They were most recently on-site three months ago, and we're currently trying to arrange some microbiologist audit activity. No problems there. And, US FDA provides overview of the sterile-products activity in several ways.

 

[RobertvanBoxtel]

Re: Notified Body Surprise Audits Required in 2014

You are correct, as for Class I (no s, no m) NB's are not involved. But as indicated your EU AR might be inspected.

 

[Ajit Basrur]

Re: Notified Body Surprise Audits Required in 2014

Great discussion, MIREGMGR and RobervanBoxtel