Documents of External Origin: Do I have to revalidate?

There have been a number of standards harmonised recently which have undergone revision. Monir El Azzouzi & I spoke of these the most recently I was on Easy Medical Device podcast discussing Sterilisation. Here is the link for reference - https://lnkd.in/dxnxkE3H

With the changes in these standards, many of them will typically affect validated processes such as sterilisation or bioburden for example.

This then begs the question, do I have to revalidate?

The answer (as always) is it depends.

My recommended approach is get your hands on a copy of the new standard (or the amendment), conduct a gap assessment between your QMS and any relevant validations and act accordingly. Don't forget to update your List of Applied Standards...

When standards undergo harmonisation, typically the main change that occurs is an annex is added to the back of the document that aligns it to the elements of the regulation it is harmonised to. This enables you to see what parts of the standard will presume conformity to the regulation.

In the example of ISO 11137, an amendment was made that tweaked some small elements of the standard as well as the annexes to the regulations being added. More specifically, the changes were focused to the following sections:

• 4.3.4 - The following was added to the end of the subclause - detailed guidance on dosimetry and associated measurement uncertainty is given in ISO 11137-3.

• 11.2 - Replaced the second sentence with - the procedure(s) shall define the requirements (see 9.4.3 or 9.4.4 as appropriate) for designating a sterilisation process as conforming.

If you need any medical device consulting, please feel free to reach out!