The way in which devices are regulated in the EU is very different from the way they are regulated in the United States, especially
in terms of the clinical data required for premarket approval. This has introduced significant differences in time-to-market
approval for the United States versus the EU, particularly in the case of high-risk Class III and Class IIb implantable devices.
As a result, some U.S. physicians have experienced one- to three-year delays in access to certain important technical innovations
such as drug eluting stents compared to their European colleagues.1 This article will explain why these timelines can differ so extensively by examining the clinical data requirements for
market approval in the two systems.
EU procedures
Medical devices are regulated in the European Union by three EC Directives.2 The main directive, which covers the vast majority of medical devices from surgical gloves to life sustaining implantable
devices such as heart valves, is the Medical Devices Directive (MDD). The MDD is supplemented by an older directive on active
implantable medical devices and a newer directive on in vitro medical devices. These three EC directives have been enacted
("transposed") into the national laws of each EU Member State, resulting in a legislative framework comprised of literally
dozens of medical device laws. The medical device directives are known as "New Approach" directives. This means that medical devices bearing a CE marking
can circulate freely throughout the EU without any barriers. Examples of other products regulated by "New Approach" directives
include pressure vessels, toys, and personal protective equipment.
The underlying principle of the "New Approach" is as follows. Each of the medical device directives contains a legislative
list of "Essential Requirements" that must be met by any product falling within its scope. In the MDD, the list of Essential
Requirements can be broken down into two groups: 1) a set of general requirements for safety and performance that applies
to all devices, and 2) a list of specific technical requirements with regard to design and manufacturing that may or may not
apply depending on the nature of the device. For example, the technical requirement for electrical safety would not apply
to a urinary catheter.
The Case for Trial Data on EU Devices
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Compliance with the technical requirements is generally demonstrated by using the relevant European Harmonized technical standard.
The need for clinical data in the CE marking process arises from the general requirements for demonstrating safety and performance.
CE marking process
A key aspect of medical device regulation in the EU is that the responsibility for ensuring that devices meet the Essential
Requirements lies with the manufacturer. For low risk devices (Class I) such as a tongue depressor or colostomy bag, the manufacturer
is allowed to self declare conformity with the Essential Requirements. For medium- to high-risk devices (Class IIa, IIb, III),
the manufacturer must call on a third party to assess conformity. To some degree, the manufacturer may choose among methods
for "conformity assessment" of the device and/or manufacturing system. The end result is certificates of conformity that enable
the manufacturer to apply a "CE marking" to the product.
Another major aspect of the CE marking process is that, unlike pharmaceutical products, the medical device "conformity assessment"
is not conducted by a regulatory agency for drugs and devices (i.e., a Member State Competent Authority or a central authority
such as the EMEA). The CE marking system relies heavily on "Notified Bodies" to implement regulatory control over medical
devices.
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