BS EN ISO 13485:2016 harmonized under the Directives for medical devices

European Commission publishes additions to the list of standards cited in the Official Journal

European standards that are cited in the Official Journal of the European Union (OJ), called harmonized standards, provide a presumption of conformity for the regulatory requirements for which they are cited. There have been long delays in getting new and revised standards added to the list of standards harmonized for the Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD). Harmonized European standards include a European Foreword and one or more Annex Z. Where the European Standard is an adoption of an international standard, the European Foreword includes a cross-reference table between each normative reference in the international standards and the equivalent European standard. An Annex Z for each applicable Directive describes the extent of the presumption of conformance with the regulatory requirement by linking the clauses of the standard with the applicable regulatory requirement.

On 17^th November 2017, an update to the list of harmonized standards was published in the OJ. Included in the list of standards was BS EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, including the corrigenda to the European Foreword and Annexes Z. BS EN ISO 13485:2016 has now been harmonized for the AIMD, MDD and IVDD. The inclusion of BS EN ISO 13485:2016 in the list of harmonized standards has been long awaited because the clock for the transition period from the previous edition has been ticking and ends at the end of February 2019.

The OJ publication of 17th November also added two other important standards with wide applicability to the list of harmonized standards. These are:

• BS EN ISO 14155:2011/AC:2011 Clinical investigation of medical devices for human subjects — Good clinical practice for the AIMD and MDD.
• BS EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (Corrected version 2017-03) for the AIMD, MDD and IVDD.

The European Standards Organizations and the European Commission are working on the standardization request for standards to support the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). While these discussions are ongoing, Technical Committees are developing programmes to tackle revisions of existing standards and drafting of new standards. A draft CEN Technical Report - FprCEN/TR 17223 -  Guidance on the relationship between BS EN ISO 13485: and European MDR and IVDR – has just been issued for ballot. This draft Technical Report provides the information usually contained in an Annex Z. It has been prepared to establish a consensus on the relationship between BS EN ISO 13485:2016 and the new Regulations. While the Technical Report does not have the status of a harmonized standard, and so does not provide a presumption of conformity with requirements in the Regulations, it incorporates information that can help organizations who are planning or starting their transitions to the new Regulations.

There are a number of other resources available to help with transition planning, including BSI’s free white papers and Compliance Navigator.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.