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...