Cert Of Conformity Questions Remain From EU Devices Directive Revisions
This article was originally published in The Gray Sheet
Executive Summary
It is unclear whether companies will need to revise their existing certificates of conformity in order to comply with upcoming revisions to the Medical Device Directives in Europe, according to Hogan & Hartson attorney Elisabethann Wright
You may also be interested in...
Europe In Brief
European clinical evaluation guidelines: The European Commission in December issued revised 1clinical evaluation guidelines explaining how manufacturers should conduct and document clinical evaluations of devices both before and after putting them on the market. "The clinical evaluation is expected to address the significance of any risks that remain after design risk mitigation strategies have been employed by the manufacturer," the guidelines state. The document notes that the extent of clinical evaluation needed depends on the nature, classification, intended use and risks of the particular device. For many devices embodying incremental modifications, it will be possible to draw on clinical experience with and literature reports on the safety and performance of equivalent devices, the guidelines note. For other devices - such as high risk devices, devices based on technologies where there is little or no experience, or those that represent a new clinical use - clinical investigations are likely to be required. The new guidelines, entitled MEDDEV 2.7.1 Rev. 3, take effect March 21 (2"The Gray Sheet" Aug. 17, 2009). They apply to medical devices generally and the device component of combination products; they do not cover in vitro diagnostics
Europe In Brief
European clinical evaluation guidelines: The European Commission in December issued revised 1clinical evaluation guidelines explaining how manufacturers should conduct and document clinical evaluations of devices both before and after putting them on the market. "The clinical evaluation is expected to address the significance of any risks that remain after design risk mitigation strategies have been employed by the manufacturer," the guidelines state. The document notes that the extent of clinical evaluation needed depends on the nature, classification, intended use and risks of the particular device. For many devices embodying incremental modifications, it will be possible to draw on clinical experience with and literature reports on the safety and performance of equivalent devices, the guidelines note. For other devices - such as high risk devices, devices based on technologies where there is little or no experience, or those that represent a new clinical use - clinical investigations are likely to be required. The new guidelines, entitled MEDDEV 2.7.1 Rev. 3, take effect March 21 (2"The Gray Sheet" Aug. 17, 2009). They apply to medical devices generally and the device component of combination products; they do not cover in vitro diagnostics
Europe In Brief
Guidance on revisions to Medical Device Directives: On June 5, the European Commission issued 1guidance on revisions made to the Medical Device Directives in 2007 that will take effect on March 21, 2010 via Directive 2007/47/EC (2"The Gray Sheet" June 1, 2009). The guidelines recommend that manufacturers of new types of devices, devices that have been reclassified under the revised classification rules and devices undergoing changes subject to prior assessment by a notified body complete a conformity assessment by a notified body before that date. Products already on the market prior to the 2010 deadline to which the revisions do not apply will only be subject to general market surveillance provisions. Manufacturers of all classes of devices on the market before the 2010 deadline must issue a Declaration of Conformity for that device stating compliance with Directives 90/385/EEC or 93/42/EEC, as amended by Directive 2007/47/EC. If the device's conformity evaluation requires a notified body, that notified body must check compliance with the new legislation