You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming. After a little digging into the changes to EN ISO 14971 and EN ISO 13485, hopefully I can provide you with a little clarity.
ISO standards are global standards; they provide a main point of reference for different implementations of the standards. “EN” in front of the standard indicates that it is the European harmonized version of the standard. In the cases above, the EN version of the standard has the same exact content as the ISO standard and in addition it has a few appendices that detail the relationship between the standard and the European Directives (the MDD, AIMDD, and IVDD).
If you are selling a medical device in Europe, somewhere in your Technical Files and Declarations of Conformity, you most likely state that you comply with EN ISO 13485 and EN ISO 14971. Complying with a harmonized European standard provides a “presumption of conformity” with the requirements of the MDD, AIMDD or IVDD, whichever is applicable. Therefore, it is important to understand what is in those standards, so you ensure you are satisfying all of the requirements of the directives.
EN ISO 13485:2012 has the same requirements as ISO 13485:2003, however the relationship between ISO 13485 and the directives has changed, and is described in the annexes. The same logic applies for the updates to EN ISO 14971:2012 from ISO 14971:2007.
To ensure your technical documentation and quality system meet the requirements of the directives, your company may assess the impact of the new appendices in the standards. This impact assessment will reveal whether or not there are updates required to your quality system, risk management file, design documents, etc.
Below are some websites and discussions (mainly other blogs) that I have found useful in researching the updates to EN ISO 14971 and EN ISO 13485.