Proposed New EU Guidelines on Stability Testing Medical Devices

Stability Testing Medical DevicesAccording to proposed new EU guidelines  which seek to amend current Directive 2001/83/EC on Medical Devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, it is suggested that there will be increased requirement for evidence of stability testing medical devices.

Manufacturers of Medical Devices will be required to provide data on stability testing during product development.

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Proposed EU guidelines for Medical devices 2012
Proposed EU guidelines for in vitro Medical devices 2012