ISO 13485:201X - 3rd Revision - Stockholm September 2014

Enews - 16 September 2014

Outcome of the Application of Quality Systems to Medical Devices Meeting, Stockholm September 2014.

Following the meeting of ISO Technical Committee 210 Working Group 1, with 50 delegates from 23 Countries in Stockholm, 8 - 10th September 2014, BSI would like to provide an update for you. The aim of the meeting was to review the approximately 870 comments received on the Draft International Standard (DIS) for ISO 13485, a significant number of comments were reviewed and revised text compiled.

Annex SL format

The reviewed comments included the format of the standard, with discussions around consistency with the Annex SL structure of the upcoming ISO 9001 revision.  The conclusion was that the Annex SL format was not accepted and it was agreed to follow the format as detailed in the design specification, i.e. ISO 9001:2008.

Next Steps

The group did not complete the review of all the comments submitted on the DIS ISO 13485. Another meeting of the Working Group has been scheduled for early December 2014; this meeting will complete the review of the comments and prepare the document for a 2nd DIS ballot.

Timings for the review

The required ISO procedural rules will be followed including:

  • Two month voting period
  • Translations for the CEN/CENELEC parallel vote under the provision of the Vienna Agreement

It is therefore anticipated that comments on the 2nd DIS will be reviewed in the 3rd quarter of 2015. Until the review of the comments received on the 2nd DIS occurs it is not possible to provide an accurate publication date of ISO 13485 3rd revision, suffice to say, the availability of this standard and ISO 9001 revision - expected 4th quarter 2015 - will be very close.

How can BSI help?

Should you have any comments specifically relating to ISO 13485 or any further questions please contact me using the following email address: 

Yours Sincerely,

Paul Sim

Regulatory Affairs Manager, BSI

Chairman BSI CH/210