In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to the Medical Device Directives (Annexes ZA, ZB, ZC) in EN ISO 14971:2009. The outcome was that CEN decided to publish a new edition of the standard.
This standard is essential to conformance with the EN requirements and will make the purchase of the EN edition mandatory for medical device manufacturers certifying to the standard for sales in Europe.
Here you can download document, that describes changes coming with the new version of this standard: EN ISO 14971:2012 Published.