CE Marking Medical Devices - Unannounced Audits

Enews - 05 February 2014

CE Marking Medical Devices - European Commission Recommendation of 24th September 2013 (2013/473/EU)

You will be aware that in September 2013 the European Commission published the above - Recommendation on the audits and assessments performed by Notified Bodies in the field of medical devices, as part of the implementation of the post PIP Immediate Action Measures.  The following link to the EU Commission website will take you to the document:

European Commission Recommendation of 24th September 2013 (2013/473/EU)

Unannounced Audits

The most significant change introduced by the Commission Recommendation is within Annex III, which specifies the requirement for regular "unannounced audits". These are in addition to the current program of compliance audits conducted by Notified Bodies.  This change applies to manufacturers holding EC certificates under any of the three EU Medical Devices Directives i.e. MDD, AIMD, IVD, where the legal provision for unannounced visits exists.

Manufacturers will be subject to an unannounced audit at least once every three  years, and this frequency will need to be increased should the devices bear a high risk.

The Commission Recommendation states that these "unannounced audits" must be unpredictable and without prior notice, so there will be no communication with your company prior to the audit.  The BSI Notified Body auditors will present themselves at your premises, and your company must provide immediate and unrestricted access. 

Access to your critical sub-contractors and crucial suppliers by the Notified Body may also be required, and will be subject to identical requirements, in situations where this is likely to provide more effective control by the Notified Body. This right of access will need to be covered in your contracts with these suppliers.

When will these changes come into effect?

Our designating Competent Authority (MHRA) expects that Notified Bodies, including BSI, will introduce unannounced audits programs in the first half of 2014. 

How can I inform my Senior Management Team of these critical changes?

Please find included in this communication a copy of a letter addressed to your Chief Executive / Managing Director / Senior Site Executive from BSI Global Medical Device Director, Mr Gary Slack.  We would be grateful if you would forward this letter and a copy of the EU Commission Recommendation to the appropriate individuals in your company.  This has been provided in order to ensure that senior management is aware of the requirements of this recommendation and the associated responsibilities, and can ensure continuing regulatory compliance for your devices.

When will I receive further information?

BSI will be communicating with you in the coming weeks, when we have completed our review and implementation plans.  Please look out for further communication from us. In the meantime, should you have any questions please contact your BSI Scheme or Client Manager who will be happy to assist with your questions.

Yours faithfully  

John Howlett,

BSI Head of Notified Body