Background
Recently there has been much discussion and many questions on the approaching requirement for European Notified Bodies to perform regular unannounced audits of manufacturers holding medical device CE certification.
The need for routine unannounced audits by Notified Bodies was originally stipulated as part of the post PIP Immediate Action Measures announced by then EU Commissioner, John Dalli, last year. The new Commissioner, Neven Mimica, has pressed on with these plans.
The legal provision for unannounced visits exists with the three current Medical Device Directives (MDD 93/42/EEC, AIMD 90/385/EEC and IVDD 98/79/EC), although to date they have not been conducted by BSI or other Notified Bodies across all CE certified manufacturers on a routine basis.
The drafts of the New Medical Device and IVD Regulations published in September 2012 also contain provisions for unannounced audits.
Current and Future Requirements
As of today, nothing is finalized. However unannounced audits are coming, and will not be optional for Notified Bodies to perform or for manufacturers to receive.
A new Commission Recommendation, ‘Audits and assessments performed by notified bodies in the field of medical devices’, is expected to be published in September 2013. It will include a detailed section specifically on requirements for Notified Bodies to implement a regular program for unannounced visits.
Key requirements from this section of the Draft Commission Recommendation include:
- Unannounced audits to the manufacturer or one of its critical subcontractors or suppliers of crucial components.
- The unannounced audit must be additional to the regular assessment cycle and at least one day by two auditors.
- At least one unannounced audit per 3rd year with increased frequency for high risk device manufacturers and / or manufacturers with a poor history of compliance, or where specific information provides reasons to suspect non-conformities of the devices or their manufacturer.
- Specified areas of focus for the visit. These include manufacturing, testing, linkage of manufactured items to the technical file and device specifications, identification and traceability, reconciliation of materials and critical processes, plus further testing of devices with a design or type examination certificate.
BSI Plans
BSI Medical Devices will not instigate a routine program for unannounced assessments until after the Commission Recommendation has been published, so that we can understand properly the requirements of European Authorities before undertaking the audits. In anticipation, we have started to build a BSI policy for the process and conduct of unannounced audits. However, only once the Commission Recommendation is finalized and we can review definitive requirements, will we take the necessary steps to finalize our plans to introduce and implement such unannounced audits, thus ensuring alignment with any expectations of the European Authorities, including MHRA and ZLG (UK and German Competent Authorities).
At that time, and ahead of this as further information becomes available, we will communicate to all Medical Device customers with BSI CE Certification our plans and the potential implications.
Manufacturers should take every opportunity through their trade associations to understand and begin preparations for the new requirements, just as BSI is doing.If you have questions in the meantime please discuss with your BSI Client or Scheme Manager.
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