Medical  Device   &  QA  Consultancy

September 2002

Clinical Data & Performance Validation

* Follow this link for the Regulatory Requirements

GUIDANCE -

* Make a Performance claim and reference the data @ ER # 3 in your ER Checklist.

* At ER # 14 reference the Annex X and the Clinical Evaluation data that supports / proves that the Performance claimed has been met and that the Intended Purpose and Indications For Use are valid.

* NB - Document which method has been used to comply with Annex X, ie: Literature route or Clinical Trial.

* If the Literature route is chosen, then a Report must be compiled, by an appropriately qualified person, to demonstrate that the Performance Objectives have been met. See document for further information.   

September 2002

Demonstration of continuing regulatory compliance

* Notified bodies are checking how a manufacturer ensures that he is complying with the regulatory requirements, on a continuing basis.

BACKGROUND

* The regulations are being reinterpreted on an ongoing basis, by the Competent Authorities, in the light of Reported Incidents, Product Recalls and other information being brought to their notice.

GUIDANCE

* Look upon your Management Review as being a "Process".

* Inputs to the Process would include the following;

            - Periodic review of applied standards, to ensure latest version has been considered

            - Results of actions ensuing from Post Market Feedback

            - Information from Competent Authority & Notified Body.

            - Review of changed regulations

* Output from the process would be a documented judgment as to whether or not continuing regulatory compliance is being accomplished. If not, then appropriate Corrective Action must be taken.

January 2002

Process residues, removal of, especially where Implantable devices are concerned.

ADVICE -

Identify all cleaning materials used in processes / manufacturing.

Include your Subcontractors / Outsourcers

Identify where harmful  "process residues" might be an issue.

Ensure that you have procedures to effectively remove any Residues.

Incorporate "process hazards" into your Risk Management, in accordance with EN 14971

Validate the residue removal process.

Document all the above.

Make a reference to ER # 7.2 and clause 4.9 [C] 4 as necessary.

Review the need to re-evaluate all the above, on a continuing basis, as changes take place.

August 2001

What issues are Notified Bodies focusing on currently, during Medical Device audits?

- Recently, it has emerged that there is a distinct lack evidence of RA/QA departments being involved in the review and approval process of Advertising Literature. As a consequence,  it has been found that Sales Brochures and Media Advertising Campaigns are making false or exaggerated Performance claims, which are not supported by the Clinical Data in the Technical File(s).

Our advice is to make sure that your procedures ensure Regulatory / QA involvement at the appropriate stages of a products Life Cycle. For example: Design Input and Design Output / Verification when "Labeling" issue are being reviewed and approved. Your procedures should also ensure that Changes to "Labeling" and also "New Labeling" after a Product launch has occurred, are subject to the appropriate RA/QA approval before release.  

HOME PAGE

Back to Top

For further information on any of the above issues or to post a further Question, please use this LINK  MDQA Feedback

Return to Medical Device & QA Consultancy's HOME PAGE

Copyright © 2001  Medical Device & QA Consultancy. All  rights reserved.
Revised: September 14, 2002 .