European amendment published for medical devices quality management system standard

EN ISO 13485 amended to show relationship with European Regulations for medical devices

An amendment to EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes – was published in September 2021. The amendment replaces the European Foreword and Annexes ZA, ZB and ZC. These Annexes Z from the previous edition of the standard showed the relationship between the clauses of the standard and the requirements of the three European Directives for medical devices – those being the Directives for active implantables, medical devices and in vitro diagnostics. These three Annex Zs have been replaced by two new Annex Zs - designated ZA and ZB – which show the relationship between the clauses of the standard and the requirements of the Medical Devices Regulation ((EU) 2017/745 ) (MDR) and In vitro Diagnostic Medical Devices Regulation ((EU) 2017/746) (IVDR).

The introduction to each Annex Z indicates that the standard is the adoption of an international standard and therefore does not cover exactly the European requirements for a quality management system (QMS). Therefore, manufacturers and conformity assessment bodies need to integrate the QMS requirements in the European Regulation into the processes provided by EN ISO 13485. The information provided in the tables in the Annex Zs will support this process by indicating whether the European requirements are covered, partially covered or not covered by the content of the standard. For example, the European Regulations require the incorporation of processes in the QMS for clinical evaluation, risk management, post-market surveillance and assignment of unique device identification. Although EN ISO 13485 requires the integration of these processes into the QMS in accordance with regulatory requirements, it does not explicitly include the details of the European Union regulatory requirements within the standard.

In addition, the introductions to the Annex Zs point out that the definitions used in EN ISO 13485 might differ from the specific definitions in the European Regulations. For the purposes of supporting European requirements, the definitions in the regulations take precedence.

Annexes ZA and ZB to EN ISO 13485 contain three tables. These tables map out the relationships between the clauses of the standard and the regulatory requirements QMS in the:

• general obligations of the manufacturer in Article 10;
• conformity assessment based on QMS and assessment of technical documentation (Annex IX); and,
• conformity assessment based on product conformity verification (Annex XI).

It is noted that, in addition to QMS requirements, Article 10 and Annexes IX and XI of the European Regulations include descriptions of regulatory processes and activities undertaken by the notified body, competent authority and European Commission. As these activities are outside of the scope of EN ISO 13485, they are not covered by the standard.

Publication of the amendment to EN ISO 13485 opens the door to the harmonization of EN ISO 13485 as providing a presumption of conformity with the requirements of the European Regulations, with the extent that the requirements are covered being described in the Annex Zs. It is hoped that the standard will be included in the next list of harmonized standards published in the Official Journal.

BSI have published the amendment to the European standard as BS EN ISO 13485:2016 + A11:2011. The British Standard adoption additionally includes a national annex, designated Annex NZ. This Annex NZ shows the correlation between the standard and the relevant UK legislation, i.e., the UK MDR 2002, as amended. The Annex NZ contains three tables designated NZ.1, NZ.2 and NZ.3. These tables show the relationship with the QMS requirements in the three parts of the UK MDR relating to active implantable medical devices, general medical devices and in vitro diagnostic medical devices respectively.  This annex provides the potential for the UK Government to designate the standard for providing a presumption of conformity with specific aspects of the UK MDR.

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