Ask a Question

The partners and associates are excited to announce a new feature that allows you to pose a question for discussion. Each week we will pool our expertise and answer.

You can browse the question and answer archives, forward one to a colleague and even submit feedback yourself. We will look forward to many interesting discussions on regulatory, product testing and quality management system issues.

If you ask a really good question we will even get some of our colleagues such as EU competent authorities, regulatory inspectors or notified body technical managers to give their views as well.

You will want to bookmark this page as the discussion changes each week with new questions/answers, feedback, examples and links.

Ask a question

This Week's Question:

"Has 'ISO 15223-1:2007, symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General Requirements' superseded 'EN 980:2003, Graphical symbols for use in the labelling of medical devices?'

Chris Pereira, Vice President of Operations, MedStent Inc.

Our answer... Unfortunately no, EN 980:2003 is the harmonized European Norm for all medical device directives. If you CE Mark your product compliance with the requirements of EN 980 is mandatory and your notified body will seek objective evidence as part of their quality system registration and surveillance assessments and/or design dossier reviews. ISO 15223 may very well supersede EN 980 and even the FDA is giving it very serious consideration, but for if you export to Europe you will need to comply with EN 980.