;   Medical Translation Insight: Who is afraid of clinical data requirements? - ForeignExchange Translations

Clinical Data Requirements under the New MDD & AIMDDThe Medical Device Directive (MDD 93/42/EEC) as well as the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) have been significantly changed by the European Amended Device Directive (2007/47/EC), and many of these changes are expected to become active in March 2010.

On one hand there are broader definitions of "medical device" and the resulting requirement to translate software is raising a lot of questions from medical equipment companies.

The updated directives will prove challenging - especially for Class I and Class IIa medical device manufacturers, who may now be expected to add clinical evaluations to their current technical documentation in the EU. Clinical evaluations must follow a well-defined and methodologically sound procedure.

Emergo has a good description of this new emphasis on clinical data:

Clinical data are defined as "the safety and/or performance information generated from use of the data, derived from clinical investigations of the device, clinical investigations reported in the scientific literature, and reports on clinical experience."

A requirement, 6a and 5a, was added to the Essential Requirements of the MDD and AIMDD, respectively, that "Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with" the appropriate section, Annex X for MDD and Annex 7 for AIMDD. Annexes II, III and VII of the MDD are revised to reflect the clinical evaluation in accordance with Annex X.

In Annex X and Annex 7, there is a stipulation that the clinical evaluation must follow a defined and methodologically sound procedure, and the MDD deletes the reference that particularly implantable devices and Class III devices require clinical data. It is expected that clinical evaluations will be expected of even low-risk devices, including Class I devices.
To learn more about expectations for clinical evaluations in the new MDD and for suggested templates for clinical evaluation reports (literature reviews and clinical studies), be sure to listen to Joy Frestedt's presentation on Clinical Data Requirements under the New MDD & AIMDD.


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