ISO 14971:2009 was published last year by BSI with three additional annexes to show links to the applicable device directive. Read a summary of the new ISO 14971 annex for the MDD (Medical Device Directive) here. ISO 14971 Update
So is it worth paying out for the new standard? – I will leave you to judge that one but in terms of the status of ISO 14971:2009, there is much confusion…
- The BSI copy of ISO 14971:2009 has an ISO copyright of 2007 because it is the same document (except for the annex listed above)
- The ISO on line store does not list the 2009 version and states that the 2007 version is current
- The European Journal (the source for all applicable harmonised standards) lists ISO 14971:2007 as the standard to comply with
So which standard do we list and use? In terms of strict compliance the 2007 version is listed in the EU Journal and therefore is the prevailing harmonised standard to use.