Update on ISO 13485:201X – 3rd revision

Enews - 29 April 2014

ISO DIS 13485:201X is now available for comment

The development of the next revision of ISO 13485 continues by the International Standards Organisation Technical Committee 210, Working Group 1 (ISOTC 210/WG1).

The Committee Draft (CD), published in 2013 received in excess of 500 comments, the committee reviewed these and the Draft International Standard (DIS) was published for public comment on the 20th February 2014.

We are now within the required 5 month voting period for comments to be submitted by the National Standards Bodies to ISO Central Secretariat and this period will close on the 20th July 2014. The closing date for submission of your comments via the BSI website is 20th June 2014.

What will change from the current standard?

The subject areas in discussion continue to be broadly consistent with that outlined in the Design Specification including:

  • Management responsibility
  • Corrective Action Preventative Action (CAPA)
  • Software validation
  • Supply chain
  • Outsourcing
  • Risk management
  • Post market activities
  • Process validation
  • Product lifecycle management
  • Annex Z’s to EN ISO 13485
  • Alignment with ISO 9001 etc.

To assist users in their understanding and application of this new Standard additional tables correlating ISO 9001 and the previous version of ISO 13485 have been included. In addition the supplementary Annex Z’s in support of the European Medical Devices Directives have been included, in anticipation of the next revision of ISO 13485 being harmonized under the three Medical Device Directives. This would mean ISO 13485 and EN ISO 13485 would be published in a similar timeframe. Users can then utilize the Harmonized Standard within Europe which provides for the "Presumption of Conformity" under the applicable clauses of the Directives.

When will this change affect me?

The DIS comments will be reviewed in September 2014 at a meeting of ISOTC 210 Working Group 1 in Stockholm, Sweden. From this meeting it is hoped the Final Draft International Standard (FDIS) text will be compiled and issued for the required 2 month vote late in the fourth quarter of 2014. It will then be possible, assuming a yes vote is achieved, to publish ISO 13485:201X late in the 1st quarter 2015 or early 2nd quarter 2015.

With the introduction of the standard it is anticipated that some form of transition period would be determined, at this time there is no indication what that might be. Adherence to this timescale is important recognizing the progress and development of ISO 9001, due to be published 4th quarter 2015, and the requirements of Annex SL applicable to all Management System Standards.

This revision has also been drafted recognizing that it will have to support the existing European Medical Devices Directives and the proposed European Medical Device Regulations when they are published in the future. Some of the content has therefore been specifically drafted to accommodate this requirement.

What can I do now?

BSI is the National Standards Body in the United Kingdom and the document can be viewed on our website

Or it is on sale in the BSI shop

Or from the ISO website

Or please contact your relevant National Standards Body to obtain a copy of the DIS.

BSI are always looking for new members on standards committees, if you are interested in being involved please visit the website for more details: http://www.bsigroup.com/en-GB/about-bsi/uk-national-standards-body/how-to-get-involved-with-standards/

Is there anything else I should know?

The medical device regulatory world is facing unprecedented change over the next few years, with the revision of the three main Medical Device Directives, introduction of new requirements for Notified Bodies, including the focus on Unannounced Audits. It is important you stay up to date with the implications of these changes. Further information can be found via the following links:

Unannounced Audits

Latest update on the changes to the Medical Device Directives

Where can I get more information?

Further information about how all Standards are written please visit our website.

BSI has created a LinkedIn group to ensure that the information is shared in a timely manner, please sign up to BSI Global Medical Devices LinkedIn page to receive all the latest updates.

How can BSI help?

Should you have any comments specifically relating to ISO DIS 13485 or any further questions please contact me using the following email address: UKISO13485@bsigroup.com

Paul Sim,

Regulatory Affairs Manager,

BSIChairman BSI CH/210