Se celebró la reunión del subcomité de UNE que participa en la elaboración de la normativa internacional y española de electromedicina para revisar las distintas normas en proceso de aprobación. Como siempre Jose Antonio Jimenez jjimenez@une.org estuvo al frente de la reunión moderando las distintas aportaciones.
En este caso nos reunimos para revisar el borrador de la futura norma horizontal EN ISO 14971:2019 y su guía la EN ISO 24971:2019, nos congratulamos en que nuestros comentarios a la edición previa fueron muy similares a los remitidos por otros países y recogidos en esta nueva y consensuamos el voto positivo para esta pero con unos comentarios.
Estos fueron los comentarios propuestos a la ISO 14971:
|
Comments |
Proposed change |
| Despite the standard indicate in the Introduction that (lines 111 to 114) is applicable to suppliers and other parties: “This document could be used as guidance in developing and maintaining a risk management process for manufacturers of other products that are not necessarily medical devices in some jurisdictions and for suppliers and other parties involved in the medical device life-cycle” and in the Scope (line 162): “The requirements of this document are applicable to all stages of the life-cycle of a medical device” no clear reference is included to crucial suppliers and critical subcontractors and controls including a quality agreement as indicate #4.1.5 ISO 13485:2016 which include risk management |
To include in the rationale this reference to risks from outsourced / subcontracted activities. Append to lines 758-759 the underlined text: “apply risk management principles to a medical device from its initial conception until its ultimate decommissioning and disposal. When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements. The controls shall include written quality agreements. |
| The annex Z must be reviewed to address the MDR in a more accurate way | Review all the text |
y para la ISO 24971:
|
Comments |
Proposed change |
| Despite the guidance indicate in 4.1 that (lines 174 to 175) is applicable to all the life-cycle: “ISO 14971 requires that the manufacturer establishes, documents and maintains an ongoing risk management process throughout the life-cycle of the medical device” corresponding with the content of the ISO 14971 in the Scope (line 162): “The requirements of this document are applicable to all stages of the life-cycle of a medical device” no clear reference is included to crucial suppliers and critical subcontractors and controls including a quality agreement as indicate #4.1.5 ISO 13485:2016 which include risk management |
To include in the rationale this reference to risks from outsourced / subcontracted activities. Append to lines 185-187 the underlined text: “If a large corporation consists of separate entities, for example business units or divisions, then top management can refer to those individuals who direct and control that entity. Each entity can have its own risk management system (and its own quality management system). This is also applicable to subcontractors of outsourced processes that affects product conformity to requirements. The manufacturer controls to the suppliers / subcontractors shall include written quality agreements with this requirements. |
Se decidió ademas abrir seguimiento del proyecto de norma sobre «renovación de equipos de diagnóstico de imagen médica»:
Otra decisión importante fue la creación de un grupo de trabajo para la revisión de la guía UNE 209001:
Os iremos informando.