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News and Views 2007 June Archive


News and Views: High Priority

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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