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
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
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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