GHTF Release New Standard

In light of the recent PIP breast implant adverse events and other significant device recalls,  the GHTF has finalised a new standard called N87 (based on a previous guidance document GHTF/SG2/N54:2006). The new standard outlines a system for medical device manufacturers and competent and regulatory authorities to exchange information regarding medical device adverse events electronically.

Whilst regulatory reporting requirements remain inconsistent in a number of countries it is hoped that all medical device manufacturers and authorities will move towards the use of electronic reporting systems. N87 is designed to improve efficacy of reporting and reduce response times dramatically.  The new standard can be found here.

When it comes to regulatory reporting it is vital to ensure you know what to do and when. For guidance, visit KD&A Post Market Surveillance page.

If you have any questions regarding regulatory post market reporting, contact KD&A.