Changes in the Notified Body Postion Paper on Hybrid Audits

Recommendation

6/7 February 2024

Combination Products - Live Online Training

End of January 2023 you could already read about a 3.5 page position paper from Notified Bodies regarding their perspective on hybrid audits of medical device and IVD manufacturers. The position paper has now been updated. What is new?

The changes are not very extensive. The structure remains unchanged:

• Disclaimer 
• Background 
• Hybrid audits in connection with legal requirements 
• Audit requirements 
• Audit team qualification 
• Audit plan and duration

The reference to a guideline of the Notified Body Coordination Group (NBCG-Med) on "Best Practices" for audits using information and communication technologies (ICT) was removed in the Background chapter.

The originally mentioned advantages of a hybrid audit, compared to a full on-site audit, have now been - newly - added:

• Hybrid audits promote inclusivity

On the other hand, the following statements on hybrid audits have been dropped:

• More efficient use and availability of subject matter experts 
• Increased audit effectiveness for certain areas (e.g. evaluation of documentation) 
• Increased acceptance of teleworking

Slight textual changes were made with regard to the inspection of purchased products.

In the areas mentioned that can be audited by means of ITC, the text with regard to substantiating design and development activities that are not site-bound and of purchasing activities that are also not site-bound was also slightly adjusted.

The text of the chapter on audit team qualification has also been slightly adapted.

The last section on audit plan and duration now contains an extended passage stating that a site should be audited on site at least once during the certification period - if only to confirm its existence and to be able to verify which activities are being carried out. 

There were also some changes in the footers.

Conclusion: The changes to the position paper are not particularly extensive. 

You can find the revised document under "Notified bodies' paper on the application of hybrid audits to quality management system assessments under MDR/IVDR" version 2.