Annex 11: Does It Apply to Medical Device Companies?

Q: In a previous EduQuest-ions & Answers post, you discussed how the European Union’s Annex 11 compares with FDA’s Part 11. It’s my understanding that the EU rule applies only to pharmaceutical companies. Is that correct, and, if so, are there any risks if a device company ignores Annex 11?

A: Yes, technically Annex 11 — which took effect June 30, 2011 — applies only to “medicinal” products. However, there are some key reasons why device companies should align themselves with this EU rule for computerized systems.

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Complying now with the rule will help you meet Part 11 and go a long way to meeting future European medical device expectations.[/pullquote]

Now that the Global Harmonization Task Force is being dissolved, the EU will take a more centralized approach and apply its guidance more broadly to all regulated areas. Annex 11 represents the clearest thinking yet from the EU on the use of electronic record keeping and electronic signatures in a regulated environment. Complying now with the rule will help you meet Part 11 and go a long way to meeting future European medical device expectations (especially from a Notified Body auditor’s viewpoint).

To see more about the differences and similarities between the EU rule and FDA’s Part 11, click here for a free side-by-side visual comparison.

Answered by Martin Browning, President & Co-Founder, EduQuest (22 years as a senior FDA ORA official and field investigator; co-author of the original Part 11 rules) and lead instructor for EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 training class.

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