Recently, I had the opportunity to attend a Risk Management Conference hosted by the FDAnews. At the beginning of the conference, we all went around the room and introduced ourselves, and indicated why we were there. Not surprisingly, a majority of people were there to have a better understanding of the new EN version of ISO 14971 - EN ISO 14971:2012, and learn how to implement it into their daily risk management activities.

A previous post I wrote talks about the relationships between the EN standards and the ISO standards. In short, the EN standards are harmonized standards in Europe, and they can be used to show that you comply with the requirements of the MDD. Therefore, every time one of these standards is updated, compliance is essential in order to continue selling in Europe.

The US has a separate list of standards which they recognize. Therefore, in the case of the new EN ISO 14971:2012 version, if you are only selling product in the United States, there is no impact to you.

The main difference with standards compliance between the EU and the US was explained very well at the conference I attended. Dan O’Leary compared the approval and compliance process in the US was akin to getting your high school diploma. Once you get that 510(k) clearance letter in your hand, you never have to go back and re-visit it (as long as the design does not change). In the US, the standards that you declared conformity with during your 510(k) process are acceptable for the lifetime of the product. However, in the EU, it is more like a continuing education program. In order to stay in compliance with the MDD, there is a need to keep up to date with the harmonized standards.

This ‘high school diploma’ analogy really highlighted to me the different challenges that manufacturers face in order to sell product into these markets. Standards compliance is tricky, but doable. Make sure you understand any and all updates that are made to standards and discuss with your notified body, and you will be in good shape.

In the coming weeks, I hope to share more updates for you on the Risk Management Conference, and what is new and exciting.


- Sherri

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!