Implementing the EU Medical Devices Directive 93/42/EEC

Stage 10: Arrange your Notified Body Audit

You are now ready for your Notified Body audit. You should have been liaising with them during the implementation of your system. Approximately 4 to 8 weeks prior to the audit date you will have asked your Notified Body to review your quality system documentation. This will give you some time to implement any corrective actions that may be required, as revealed by the desk review.

The duration of the audit at your site will be typically between three and ten man days dependent upon the size of your organisation, the number of device families involved and their classification. Very large organisations will require longer audits.

During the course of the audit you will be required to demonstrate your control over subcontractors. If these subcontractors manufacture the major part of your device(s), or supply critical parts or services which could detrimentally effect the efficacy of your device(s), then your Notified Body may require to audit these organisations as well.

There may be some deficiencies ("non-conformities") found during the initial audit. The assessment team will then agree a timescale with you for appropriate corrective action to be undertaken. Dependent upon their nature, a review of your corrective actions may be completed by mail, via a desk review. In some circumstances a further visit may be required by an assessor(s).

As soon as all non-compliances have been satisfactorily cleared, the assessment team will recommend that your organisation be approved for the use of the "CE" Marking and any other associated registration (ISO 9000). This recommendation will be passed to your Notified Body's Governing Board and Approvals Panel. You should then expect formal authorisation within a few weeks.

The Notified Body is required to undertake regular surveillance of your organisation and this is generally carried out once, or in some cases, twice a year.

You are now able to place the 'CE' Marking on your device(s) which will give them freedom of access to all EU Member States. As an additional bonus, the European Commission is currently negotiating a number of Mutual Recognition Agreements (MRA's) with several non-European States. It is anticipated that the 'CE' Marking will eventually be a passport to many of the World's major markets.

References 93/42/EEC
Article 11 - Conformity Assessment Procedures
You will require a vigilance / post-market surveillance system