CEN publishes report outlining the relationship between ISO 13485:2016 and the medical device regulation (MDR) and in vitro diagnostic medical device regulation (IVDR).
CEN TR 17223, titled “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”, is set to be published late March 2018.
This Technical Report:
- Focuses on the quality management systems (QMS) elements with regards to the manufacturer’s obligations laid down in Article 10 and the conformity assessment requirements laid down in Annexes IX and XI of the MDR and IVDR;
- Addresses 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 Annex I Chapter 1, general requirements of the general safety and performance requirements, and the corresponding subclauses of EN ISO 13485:2016 because the manufacturer’s obligations laid down in Article 10 requires the implementation of a risk management system as part of the QMS. EN ISO 13485:2016 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;
- Specifies that compliance with EN ISO 13485:2016 does not provide 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 If the final text of the Annex Zs ultimately differs from CEN TR 17223, the TR will either be amended to align or withdrawn.
What does this mean to you?
Part of your transition plan to the new MDR and/or IVDR should be addressing the key changes to your QMS. As EN ISO 13485:2016 is not yet harmonised under the MDR or IVDR, and won’t be till 2019 earliest, this document can help as a support tool to identify the link between the regulatory requirements laid down in the new regulations and the standard. It will show you where the regulatory requirements fit into the structure of the standard.
Don’t hesitate to contact us for any support required with regards to your MDR or IVDR transition plan.
