The company I work for currently adheres to ISO 14971:2012. We have purchased the 2019 version and now (since we sell product to the EU) the EN 2019 version released in December. However, the EN 2019 at this time, does not include the Annex Zs. The National Foreword does state that the standard "does not contain Annex Z's" and will be updated with an amendment once finalized. If the EN 2019 version supersedes the EN ISO 14971:2012, as noted in the European Foreword, there are no Annex Z's to adhere to.
Are we just in limbo until amendments are approved? Why the intermediary release?
Are we just in limbo until amendments are approved? Why the intermediary release?