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By: Ludger Möller
News and Views: High Priority
June 2007
Content:
Update of the Vigilance Guideline (very important)
Update of the Risk Management Standard EN ISO 14971:2007
Update of the Vigilance Guideline MEDDEV 2.12-1 rev.5
The updated text has been endorsed by the Medical Device Expert
Group (MDEG). The MDEG is hosted by the Commission and consists
of Competent Authorities, Notified Body and industry
associations.
Please find the update here:
http://ec.europa.eu/enterprise/medical_devices/meddev/2_12_1-rev_5-2007.pdf
Please note that the guideline is not mandatory but provides a
very good interpretation of the directive. In complying with the
guideline you should be safe in complying with the CE mark
requirements.
The guideline has been changed significantly and therefore a
very close evaluation should take place of your complaint,
reporting and recall processes.
Regarding the timeline:
There is no transition period and we recommend updating relevant
procedures immediately. In particular in regards to the
reporting timelines and the necessary information related to
recalls.
A detailed evaluation of the changes will follow.
Update Risk Management Standard EN ISO 14971: 2007
The risk management standard has been updated. Normally you
would find the updates here:
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html
However, when we checked it was not listed yet. However,
that may happen at any time now.
Regarding the timeline:
Every standard does indicate in the foreword the transition
period. With it states when the old standard becomes obsolete.
With complying with the Medical Devices Directive it is an
imperative to comply with the risk management system standard.
In Annex I section 1 of the essential requirement the risk
against the benefit shall be weighed with each other.
We strongly recommend evaluating the standard to ensure future
compliance.
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