Technical Report 17223:2018!
2018/03/21
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TR 17223, the TR will either be amended to align or withdrawn.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.
