Report outlines the relationship between EN ISO 13485:2016 and the regulations for device

CEN publish Technical Report to assist in transition of quality management systems

BS EN ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes– was harmonised for the Medical Device Directive, Active Implantable Medical Device Directive and In Vitro Diagnostic Medical Devices Directive in November 2017. The earlier blog on this topic noted that

• the European Standards Organizations and the European Commission were working on the standardization request for standards to support the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), and
• a draft Technical Report (TR) - FprCEN/TR 17223 providing guidance on the relationship between EN ISO 13485 and the MDR and IVDR was being balloted. 

Following approval in the ballot, CEN TR 17223 is to published in late March 2018. The full title is Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation.  This Technical Report:

• focuses on the quality management systems (QMS) elements of the obligations of the manufacturer in Article 10 and the conformity assessment requirements in Annexes IX and XI of the MDR and IVDR;
• includes the relevant text from the Regulations, shows the relationships between Article 10 and annexes IX and XI and how these link with the clauses of EN ISO 13485:2016;
• includes the relationships between Chapter 1 in the general safety and performance requirements and the corresponding subclauses of EN ISO 13485 because the obligations of the manufacturer in Article 10 require the implementation of a risk management system as part of the QMS. EN ISO 13485 requires processes for risk management throughout product realization but specific details of a risk management system for medical devices are provided in EN ISO 14971;
• indicates that it does not imply that compliance with EN ISO 13485 provides a presumption of conformity with the requirements of the MDR and IVDR as it was prepared before the agreement of a standardization request.

When a standardization request is agreed, additional Annex Zs will be prepared for EN ISO 13485:2016. These will likely be incorporated through an amendment to the European adoption of the standard. The work done in preparing CEN TR 17223 will be used to prepare the additional Annex Zs. If the final text of the Annex Zs ultimately differs from CEN TR 17223, the TR will either be amended to align or withdrawn.

As manufacturers work on their transition to the MDR and IVDR, many find that addressing changes to QMS processes needs to be done at an early stage in an orderly transition. Addressing the QMS requirements in the regulations are on the critical path of their transition plans. As the formal harmonization of EN ISO 13485 under the MDR and IVDR is not expected until 2019 at the earliest, this Technical Report can be very helpful as a stopgap in identifying the linkages between the regulations and the standard; it shows where the European regulatory requirements for the QMS fit into the structure of EN ISO 13485. CEN TR 17223 will be available from the BSI shop. There are a number of other resources available to help with transition planning, including MHRA’s Introductory Guide to new medical device regulations, MedTech Europe’s flowcharts of the regulations and BSI’s transition documents, 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.