The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies (NBs). All medical device manufacturers certified under one or more of the EU Directives on medical devices (i.e. 90/385/EEC, 93/42/EEC, 98/79/EC) are now subject to an additional unannounced audit. So how are manufacturers planning for this new type of audit?
EU Commission Recommendation 2013/473/EU
As most people will now be aware, all medical device manufacturers certified under one or more of the EU Directives on medical devices (i.e. 90/385/EEC, 93/42/EEC, 98/79/EC) are now subject to an additional unannounced audit. This was the most far-reaching implication of the EU Commission Recommendation 2013/473/EU published on 24 September 2013. The provision for unannounced audits had always been included in these directives but the Recommendation formalized a process and a minimum frequency.
The April 2014 NB MED meeting in Brussels found most of the major NBs discussing the topic of unannounced audits*. All NBs present had been instructed by their Competent Authorities (CAs) to initiate unannounced audits, with most NBs already undertaking such audits, initially in a lower-level pilot phase to build up experience.
High-risk devices under discussion
The Recommendation did specify that for high-risk devices, a high-level of reported non-conformities or negative information from the market should increase the frequency from the minimum of once every three years but the detailed mechanism of how this will occur is still under discussion. There was general agreement that the requirements set out in the Recommendation could only be undertaken at the site where final manufacturing and/or acceptance testing/inspection was performed and that the majority of audits could be completed in one day with a team of two auditors.
Actions required for unannounced audits
As all manufacturers (with the exclusion of MDD Annex IV and IVDD Annex III section 6 only certified companies) will experience an unannounced audit sooner or later it is essential that manufacturers plan now for this eventuality.
Actions to be taken include:
- Responding to the requests from your NB to provide details of manufacturing locations and manufacturing schedules;
- Documenting an internal procedure on how to handle and manage a unannounced audit, taking into consideration the worst-case scenario when the appropriate management is off site;
- Briefing all staff so that such audits do not come as a surprise;
- Agreeing with your NB the critical subcontractors, critical suppliers and OEMs (when manufacturers own brand label devices) where unannounced audit access is required and changing your contracts with these suppliers to facilitate such audits; and
- Own brand labeler manufacturers must also ensure that technical files are provided to them by the OEM as it is clear that the previous arrangement of making available to the authorities on request will no longer be acceptable.
Cooperation with NBs and CAs recommended
A few manufacturers may feel that by not cooperating with their NB on providing the requested information or by refusing such audits they can avoid the understandable stress and cost of such an audit. However, this is likely to have the adverse effect of increasing the likelihood of an attempted audit at an inappropriate location or at worse making the NB and CA suspicious that information is being hidden. In either case, actions such as these are likely to increase the possibility of an unannounced audit and are therefore not recommended. In the case of outright refusal to an unannounced audit, suspension of CE certification is likely unless an adequate justification is given for the refusal.
The Recommendation set out the objectives of these planned unannounced audits, which will be product focused rather than quality management system focused. However, a second type of unannounced audit or very short notice audit is also envisaged in this document. These will be undertaken when the CA or the NB receives negative information and it is necessary to undertake an additional audit to investigate alleged deficiencies in the device design or in regulatory compliance. These will not follow a set format but will focus on the issue and the associated feedback processes, which the manufacturer should be using to correct any deficiencies.
It is clear that manufacturers and NBs are entering a period when the nature of their relationship will change and will become closer to the relationship they have with CAs in Europe.
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