EU Proposal For A Regulation On Medical Devices In The Field Of Active Implantable Devices: An Overview Of The Impact

Author:Ms Paola Sangiovanni
Profession:Studio Legale Bernascone & Soci

The Proposal attempts to create a robust regulatory framework which will aim at ensuring a greater level of safety of medical devices, enhanced transparency and traceability, reinforcement of the role of notified bodies and of national authorities, and ultimately an improved confidence in EU regulations which greatly suffered after the PIP breast implant scandal. Here are some of the changes that have a direct impact on active implantable devices.

REVISED DEFINITIONS. Partially revised definitions of what constitutes an active implantable device have been introduced in order to clarify the application of the Proposal to items that may have previously been regarded as falling within grey areas:

active devices are devices the operation of which depends on a source of power, which includes stand-alone software (which must be state of the art and take into account the principles of development life cycle, risk management, verification and validation); implantable devices now also include any device intended to replace an epithelial surface or the surface of the eye, as well as any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days. CLINICAL INVESTIGATIONS. Stricter rules are foreseen for clinical investigations on the device to be carried out under the responsibility of a sponsor (who can be the manufacturer or another legal or natural person taking responsibility for the clinical investigation) and in the framework of a clinical investigation plan. Such clinical data will have to demonstrate compliance with the general safety and performance requirements. Further, clinical investigations are subject to a unified electronic system, which will in part be accessible to the public, designed to facilitate exchange of information on investigations and events (a unified electronic system is also foreseen for registration, identification and traceability of devices, vigilance and market surveillance, and economic operators) . Clinical investigations must be performed unless it is duly justified to rely on existing clinical data alone, but reliance on existing clinical data is less acceptable than before: the Proposal now expressly indicates that a demonstration of equivalence with another device shall generally not be considered as sufficient justification to rely on existing data. This may address on of the concerns voiced by the...

To continue reading