REGULATIONS AND STANDARDS
(AIMDD) was adopted on 20 June 1990 and became mandatory
on 1 January 1995. The Medical Devices Directive (93/42/EEC)
(MDD) was adopted on 14 June 1993 and became mandatory on
15 June 1998. The In Vitro Diagnostic Medical Devices Directive
(98/79/EC) (IVDD) was adopted on 27 October 1998 and became
mandatory on 7 December 2003. Medical devices that comply with
the relevant directive, as transposed by each European country
into national laws and regulations, can be sold throughout Europe,
which addresses the previous dramatic lack of medical device
harmonisation in the region. Most readers will be aware that some
differences persist from country to country, most notably national
language and registration requirements, but the situation is markedly improved from 20 years ago.
Successful aspects
I have always believed that the European regulatory framework for
medical devices is, in many ways, an elegant approach to regulating an exceedingly complex array of products. It is a risk-based
system, with the stringency of requirements increasing in relation to
the risk level of the device. Device classification, which is necessary
for devices subject to the MDD, is the responsibility of the manufacturer, who must use a set of rules laid out in the MDD instead
of consulting a list of products, which can become obsolete over
time. Under the IVDD, the manufacturer must determine the correct
regulatory risk level by consulting certain articles and annexes in the
directive.
Medical devices must be safe and perform as intended by the
manufacturer instead of having to be safe and effective, as under
the US system. As long as it can be shown that the benefits of using
the device outweigh the risks, the manufacturer, not a regulatory
authority or third party, establishes device performance. All devices
must meet a set of general essential requirements concerning safety
and performance and other more specific essential requirements
depending upon the particular type of device.
All devices require risk analysis, which is much more clearly
defined than in other regulatory regimes, including the US system.
Manufacturers can choose a conformity assessment procedure to
demonstrate compliance with the appropriate directive. The conformity assessment procedures selected most often by manufacturers
are based upon the correct functioning of the manufacturer’s quality
system, which means that compliance with the selected procedure
generally covers more than one device. By contrast, other regulatory
regimes, including the US system, in most cases clear or approve
one device at a time. Under US requirements, some devices can be
grouped in one regulatory submission; however, this is frequently
not possible.
The implementation of many of these aspects of the European
device regulatory system has been generally successful in spite of the
recognition that improvements are needed, as is the case with any
regulatory process.
Improvement needed
What are some aspects of the system that need improvement? Reputable medical device manufacturers expend significant resources
ensuring that their devices meet regulatory requirements. Effective
market surveillance programmes help ensure that less reputable
companies are identified and that appropriate regulatory action is
taken to protect the public from unsafe devices that do not perform
as claimed. The effectiveness of enforcement programmes across
Europe, however, is extremely variable.
Notified Bodies are a vital element of the European regulatory
system, as they are responsible for assessing technical documentation and issuing certificates needed for the CE marking process.
They need to be competent to carry out these critical tasks, yet not
all Notified Bodies have equivalent resources and expertise. Measures are being taken to improve this situation; the publication of
best practices guides by the Notified Bodies Operations Group set
up by the European Commission and member states is one example.
Not all member states are equally effective in overseeing the Notified Bodies operating within their territories. If a manufacturer
contracts with a Notified Body that is unable to perform as needed,
many parties are potentially adversely affected, not least of which
are the patients and users of the devices concerned. The quality of
Notified Bodies needs to be better ensured and the variability in
competence minimised.
