Medical Device & QA Consultancy

Medical Device Directive 93/42/EEC -

POST SALES ISSUES

The following Post Sales Issues must be addressed for all Class of Medical Device;

A Vigilance / Adverse Incident Reporting procedure, covering the following;

both Adverse and Near Incidents,

Statutory Reporting Times,

Reporting to Multiple Competent Authorities, where necessary,

And other requirements of the European Vigilance Guidelines Manual.

An effective Post Market Feedback (PMF) system will contain the following;

Include both Reactive and Proactive elements,

Be Product and/or Device based,

Provide for Identification of appropriate Data Sources,

Provide for Gathering of the Data,

Effective Review of the Data, and

The determination of Resulting Actions,

Including a Link into the Design Control Change process, as appropriate.

Control and Notification of "Significant Changes"

 The procedure must define exactly what is significant and also document the procedural steps to record, report and notify. Typical issues requiring notification are;

Changes to Facility address,

Changes to a Critical Process,

Change of a supplier of a major component or service,

Changes to 'Critical Materials',

Any change which might impact on compliance with the Essential Requirements of Annex I

Additions or deletions from the Product Schedule and Declaration of Conformity.

A “New Intended Purpose” for an existing device,

Extended Performance Claims

In addition to the above, you must have procedures to control;

Effective Complaint Handling, in accordance with Clause 4.14. of ISO 13485:2000

Product Recall and Advisory Notice Issue, linking to your CAPA system and Traceability.

Systems and procedures must be in place to ensure systematic and consistent control over the above issues.

Medical Device & QA Consultancy can help you to develop the correct procedures to assure your Regulatory Compliance and also ensure that your Company maximises the benefits available from Continuous Improvement.

Please Contact Us to discuss your needs and a suitable Strategy, in total confidence.

Thank you for visiting this Web Site. A more detailed Company Profile is available. If you require further information on any Medical Device compliance issue, or if you have any suggestions to improve this Web Site, please feel free to e-mail Bernard J. Tremaine at:

bernardt@mdqaconsultancy.co.uk

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