What is the process for unannounced audits?
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.
How often will I receive an unannounced audit?
In November 2016, the MHRA confirmed a change to the required frequency for unannounced audits. The EU Commission Recommendation of 24 September 2013 led to Manufacturers being subject to an unannounced audit at least once every 3 years, with the frequency increased for high risk devices to every 2 years.
From January 2017, we will apply the new frequency requirements and switch to a new schedule based on device classification, as outlined below:
||New audit cycle
|Higher risk products
||AIMD, MDD Class III / IIb implantable devices
|Lower risk products
||MDD Class IIb / IIa / Is / Im
||Annex II List A / Annex II List B / Self-Test (under Annex IV only)