ISO 13485 Changes

BS EN ISO 13485:2012 has now been issued which will supersede the current version ISO 13485:2003.   But you may be asking yourself why the change was so low key?

The simple answer is that it is the European version that has been updated and other countries outside of Europe therefore still use ISO 13485:2003.

Why was the change made?

The change was made as a number of European countries objected to the inference that ISO 13485 inferred compliance to the Medical Device Directive.   To solve this problem, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.

So how do the changes affect me?

Practically they don’t really affect the standard.   The EU Journal has not yet published the standard as the official harmonised standard so ISO 13485:2003 is still officially the current version.   There are no new requirements, in fact there are no changes at all in the main text of the standard, and so it is expected that Certification Bodies will just issue a new certificate once the standard is harmonised.

A non commercial version of ISO 13485:2012 is available so that you can preview the changes made.

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