Italy Legal Focus

The European legislative framework for the marketing and surveillance of medical devices has recently come under public scrutiny following the PIP breast implants scandal. While such scandal is believed to be solely caused by specific flaws in market surveillance, the European system in its entirety – and in particular the absence of a centralized pre-market approval – has come under criticism.

On June 14, 2012, with the adoption of the so called "PIP resolution", the European Parliament called on the Commission – inter alia – to introduce, in addition to strengthened post-market surveillance measures, a pre-market authorization system, at least for devices falling in the higher-risk classes (IIb and III). This came as sweeping news in the European medical device diatribe, and encountered the strong opposition of the industry, as well as a cold welcome from the European Commission itself.

While the FDA, which manages pre-market approval for all medical devices placed on the US market, stepped in the debate accusing the European system to disregard the best interest of patients and their safety (while not providing earlier market availability due to lengthy reimbursement procedures), European industry representatives argued that introducing a pre-market authorization would stifle innovation, delay access to new devices and worsen the overall quality of healthcare for European patients.

Here follows a short account of the new provisions of the Proposal that are more likely to affect the timing for marketing of new devices in Europe, without doubt the most recognized advantage of the European system so far as compared to the lengthy FDA-managed procedure.

THE NEW MEDICAL DEVICE COORDINATION GROUP. The Proposal aims at establishing a group of experts, the Medical Device Coordination Group ("MDCG"), somehow similar to an advisory board, which is meant to bring together the European Commission and experts from each member states. Such MDCG would essentially be entrusted with coordination and management tasks, thus providing a centralized support framework for the exchange of information, monitoring of Notified Bodies and conduct of clinical investigations. The industry welcomed this new entity, which is expected to counterbalance the decentralized approach maintained in the Proposal and will help to achieve a better management of the whole European system.

SCRUTINY PROCEDURE. While the establishment of the new MDCG itself triggered positive reactions from the industry, its role in the brand new scrutiny procedure is at best controversial. Such procedure, in fact, requires Notified Bodies to notify the European Commission of any new applications for conformity assessment for high-risk class III devices, and enables the MDCG to review the Notified Body's assessment and submit comments based on health and scientific reasons. This scrutiny procedure has been harshly criticized as de facto creating a pre-market approval mechanism, entailing extended deadlines and increasing bureaucratic formalities and requirements on Notified Bodies during the conformity assessment. As such, it has been pointed out that the procedure itself will not increase the safety for patients, but instead will prevent life-saving products from promptly being available to European citizens.

IMPACT OF THE NEW PROVISIONS ON CLINICAL TRIALS. The Proposal also impacts the procedures and requirements for the conduct of clinical trials and devices, with a potential impact on the time-to-market for new devices. In particular, it has been pointed out that potential delays by the Commission to adopt any required implementing measures may potentially damage manufacturers and cause delays in the pre-market phase. In fact, clinical trials usually require early planning and preparation, which may both be impaired by an unclear regulatory framework. However, it should also be noted that the industry welcomed the new provisions on clinical investigations as providing a clearer European framework.

POTENTIAL IMPACT FOR COMBINATION PRODUCTS. The Proposal sets forth new requirements for the marketing of combination products, i.e., a combination of medicinal products and medical devices. In particular, it is provided that the European Medicine Agency or national medicine agencies in each Member State may review the conformity assessment issued by the Notified Body and independently assess the conclusions contained therein, thus in fact being entitled to veto the access to market of combination products.

POTENTIAL IMPACT FOR ACCESSORIES. Lastly,a new and broader definition of accessories to medical devices is provided in the Proposal, thus including all devices that not only enable, but also "assist" the device to be used in accordance with its intended purpose. While the outcome of this new change is still to be assessed, the new language may subject whole new categories of accessories to European regulations, thus potentially delaying the marketing of such devices.

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