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 FDA, which maintained that the EU system allowed devices to be placed on the market on the mere basis of laboratory testing, literature review and small clinical trials.
APPROPRIATE EXPERTISE IN THE ASSESSMENT OF AN IMPLANTABLE MEDICAL DEVICE. The Proposal confirms the system of conformity assessment by notified bodies (rather than switching to the US-recipe of centralized pre-market approval), but emphasizes the need of actual, competent and continuous pre-market and post-market controls. The Proposal, in fact, mandates that, where subcontractors or external experts are used in the context of the conformity assessment, in particular regarding novel, invasive and implantable medical devices or technologies, the notified body shall have adequate own competence in each product area for which it is designated to lead the conformity assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification. Additionally, the notified body must establish procedures for assessing and monitoring the competence of all subcontractors and external experts used.
RATIONALIZATION OF INFORMATION ON THE DEVICE. In order to increase transparency, effectiveness and availability of documentation regarding a device, certain rules of the Proposal aim at rationalizing records to be kept on active implantable devices and avoiding that controls of competent authorities drown in a sea of paper:
- SUMMARY OF SAFETY AND CLINICAL PERFORMANCE. The manufacturer is under a duty to draw up a summary of safety and clinical performance, which must be written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment and shall be validated by that body. This document, which will have to be more concise and clear than a user manual, will surely have consequences on product liability on active implantable devices.
- SUMMARY OF TECHNICAL DOCUMENTATION. The manufacturer must be able to provide, upon request by a competent authority, a summary technical documentation (STED) and grant access to the full technical documentation upon request.
- 15-YEAR PERIOD FOR KEEPING RECORDS. Manufacturers (or authorized representatives) must keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement available to the competent authorities for a period of at least 15 years after the last device has been placed on the market.
IMPLANT CARD. The manufacturer of an implantable device shall provide together with the device an implant card, which must be written in a way that is readily understood by a lay person and must be made available to the particular patient who has been implanted with the device. The card has to include: (a) information allowing identification of the device, including the Unique Device Identification; (b) warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences or environmental conditions; (c) information about the expected lifetime of the device and any necessary follow-up. Many manufacturers (e.g., in the field of pace makers) have already adopted this type of communication for many years and our guess is that they may welcome clear rules for information to patients, which institutionalize their direct contact with them. No doubt, however, that providing information regarding the expected lifetime of a device will be difficult to convey in simple lay-person terms and will have critical consequences on product liability suits.