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In 1993, the European Union
introduced the Medical Devices Directive 93/42/EEC. At that
time and during the transition period, compliance to the
directive was voluntary. By the summer of 1998, however,
the MDD had become the basis of mandatory regulatory requirements
for all medical device manufacturers selling their products
in the European Union.
Today, CE marking is required on all products that fall
within the scope of any of the European Union's New Approach
Directives (For additional information about these, including
a complete list of the current directives, see the July
2002 Quality Digest article, "The Global Marketplace
and CE Marking"). The directives cover a vast array
of products from various industries--including telecommunications
equipment, machinery and toys--in addition to medical devices.
This summer, the European Medical Devices Expert Group
published the first major report and analysis of the MDD.
This article summarizes the key points raised in the report.
The MDD provides an appropriate legal framework for regulating
medical devices, but some aspects of it require further
improvement and/or implementation, according to the MDEG
report. In particular, attention must be given to how Notified
Bodies are designated and monitored, how conformity assessments
are conducted, the classification of some devices, and how
provisions concerning clinical data and quality assurance
are implemented.
The report recognizes the complexity and pace of development
in the medical devices sector and the importance of maintaining
efficient and effective regulations. These ensure that Europeans
benefit from the safest, most current technologies. Acknowledging,
too, that different regulatory approaches are required for
different industries, the report specifically discusses
the differences between the medical devices and pharmaceutical
industries.
The report also comments upon the growing global recognition
of Europe's CE marking approach to regulating medical devices.
Other regulatory agencies are actively considering or even
adopting this approach as the basis of their own regulations.
It also provides significant inspiration for the work undertaken
by the Global Harmonization Task Force.
The report identifies the following main areas of concern:
Classification of medical devices
Conformity assessment
Notified Bodies
Clinical evaluation and post-market surveillance
Unlike some regulatory systems in which devices are officially
listed and classified by the regulator, under the MDD, the
manufacturer applies 18 rules to determine the classification
of its own product. Any medical device can be classified
by following the logical model provided by the rules, which
take into consideration a product's duration of use, degree
of invasiveness, power source and contact with patients'
bodies. A number of special rules cover anomalies and supplement
the rules. Inevitably, a very small number of devices raises
differences in interpretation among manufacturers, Notified
Bodies and competent authorities. The MEDDEV Guidance Document
published by the MDEG provides clarification on interpreting
the rules and includes examples of devices the rules are
intended to cover. (Copies of the MEDDEV Guidance Document
are available from www.bsiamericas.com/medicaldevices
.)
The report identifies three problems with the current
classification of devices:
The need to upgrade or downgrade some devices' classification.
The report suggests some devices do not achieve appropriate
classification using the current rules. Because a classification
affects the conformity assessment conducted by a Notified
Body, some devices might not be subject to a sufficiently
vigorous review in relation to their perceived inherent
risks. The report proposes that several devices be reclassified.
These include breast implants (upgraded from Class IIb to
Class III, already agreed); stents, hip implants, intraocular
lenses, ventricular assist devices, portable infusion pumps
(all up to Class III); disinfectants (up to Class IIb);
and nursing beds, wheelchairs and patient lifters (up to
class IIa). The report mentions that some devices could
be downgraded, although no current examples are cited.
Anomalies in the classification rules. The report indicates
that a limited number of anomalies occurs because of the
classification rules. For example, reusable surgical instruments
are Class I devices according to the MDD rules, whereas
single-use instruments are Class IIa, despite the fact that
reusable devices may be of higher potential risk than single-use
devices.
Incoherence in the classification rules. The report identifies
incoherence between rules six and seven of the MDD. Rule
six classifies devices that come into contact with the central
nervous system on a transient basis (i.e., fewer than 60
minutes) as Class IIa and devices that are in contact for
a short term (i.e., up to 30 days) as Class III. The report
contends that risks don't diminish with the reduced duration.
Therefore, all such devices should be classed in the highest-risk
category and marked as Class III.
The report concludes that the existing mechanism under
the directive's clause 13 would address classification issues.
This clause allows the European Commission to consider substantiated
classification cases presented by member states and take
appropriate action. In doing so, no amendment to the MDD
would be required.
One of the conformity assessment routes available under
the MDD is full quality assurance (Annex II). The report
outlines concerns about Notified Bodies adequately evaluating
the designs of high-risk medical devices during Annex II
assessments, particularly with regard to some Class IIb
devices. The report also suggests reclassifying those devices
that are of most serious concern up to Class III, which
would require a design dossier submission to the Notified
Body. Irrespective of the class devices (IIa to III) on
an Annex II quality system audit, the Notified Body is required
to include product expertise on the audit and effectively
sample and assess technical documentation, including risk
analysis, clinical data and design evaluation. A chosen
sample must reflect the risks associated with the device's
intended use, the complexity of manufacturing technologies
and the range of devices produced. The report indicates
that this area of conformity assessment needs further clarification
guidance for Notified Bodies.
The report also queries the certification validity of
devices covered by conformity assessment annexes in which
no expiration date is required. In these cases, the manufacturer's
responsibility to design and construct devices meets the
generally acknowledged term "state of the art."
The report suggests that an effectively running system can
still go "off the rails" in three years. Notified
Bodies should have the opportunity to re-examine certain
products' designs and classifications, and the report contends
that expiration dates can assist them in this context.
The report states that manufacturers and Notified Bodies
should continually monitor devices' conformity with the
current "state of the art." However, further discussion
is needed to adequately define the term as well as its consequential
effect on certification validity.
The Notified Bodies are critical elements to successful
implementation of the MDD. To ensure their systems are effective
requires consistent action by both the Notified Bodies themselves
and competent authorities. Today there are more than 60
Notified Bodies designated under the MDD. Questions exist
regarding the competency, coherency in interpretation and
transparency of their work and decisions.
Competent authorities and manufacturers have questioned
the ability of Notified Bodies to conduct conformity assessments
in all the designated product areas. Incompetence is unsatisfactory
not only from a regulatory perspective, but also because
it undermines the value of a robust conformity assessment
that might identify problems before they occur. The report
states that competent authorities should more carefully
designate and monitor Notified Bodies and allow them to
specialize in the areas for which they're designated. This
would make them more effective.
Also important is ensuring coherent interpretation among
Notified Bodies. Many recognize that the Notified Body-initiated
NB-MED Group has achieved much progress. The group drafts
and publishes Notified Body recommendations and consensus
statements, which provide a basis for consensus interpretation
and agreement about the MDD requirements. All Notified Bodies
are entitled to participate in the NB-MED Group, and most
do. However, some critics maintain that the NB-MED Group
documents aren't readily available and that not all Notified
Bodies follow the recommendations. (A complete set of recommendations
is available at www.bsiamericas.com/MedicalDevices/GuidanceDocs/NBRecommendations.xalter
.)
The transparency of Notified Bodies' certification decisions
is another area of concern. The report suggests that they
be required to make more information available about their
decisions. The Notified Body Operations Group, created in
2000, addresses and considers all concerns regarding Notified
Bodies. This group includes representatives from member
states and the European Commission.
The MDD requires that all devices, irrespective of classification,
include adequate clinical data concerning their characteristics
and performance under normal use as well as an evaluation
of any undesirable side effects. This data can be a compilation
of relevant scientific literature along with a critical
evaluation of the findings, or the results of a clinical
investigation (i.e., trial) that's included in the technical
documentation compiled by the manufacturer.
Experience has shown that there's a complete lack of clinical
data included in technical documentation for some lower-class
devices, which raises serious concerns regarding manufacturers'
claims of compliance with the directive. The report suggests
that these failings are due to misinterpreting the MDD rather
than from shortcomings in the regulatory framework or ambiguity
in the text.
The Clinical Evaluation Task Force, an expert working
group comprised of representatives from member states, Notified
Bodies and relevant industries, is reviewing the subject
of clinical data and will publish detailed guidance on issues
related to it.
The MDD includes a requirement for post-production surveillance
of all classes of devices. One part of this requirement
concerns vigilance--i.e., reporting incidents and recalls--which
is mostly a reactive activity. The proactive part is post-market
surveillance. This requirement, which hasn't always received
appropriate attention from manufacturers or Notified Bodies,
means manufacturers must document an appropriate system
for gaining and reviewing experience in the post-production
phase for the range of devices manufactured. The New Approach
Directives suggest manufacturers should proactively evaluate
actual device experience rather than relying on purely reactive
activity such as customer complaints or operating problems.
The report recommends that better guidance be developed
for post-market surveillance and that Notified Bodies follow
through with it.
Other issues considered in the report include vigilance,
the safeguard clause, confidentiality, market surveillance,
the European database and consultations with pharmaceutical
authorities. However, the most critical area identified
as requiring improvement is conformity assessment. The report
states, "Failure to act on one of these elements in
the field of conformity assessment will not produce the
required improvements." Further work by the NBOG and
CETF will provide additional guidance to benefit manufacturers,
Notified Bodies and, ultimately, patients and end-users.
Currently, the report isn't binding on the European Commission.
However, the policy conclusions drawn from it might be presented
to the European Council and European Parliament for consideration.
All in all, the prognosis is that, despite the areas under
consideration for improvement, the new approach CE marking
system works well to regulate medical devices.
The full MDEG report is available to download at www.bsiamericas.com/MedicalDevices/GuidanceDocs/OtherDocs.xalter
Paul Brooks, an expert on CE marking under the Medical
Devices Directive, is the head of BSI's Medical Devices
Group, a Notified Body. He joined BSI in 1981 and has been
working with the company's U.S. subsidiary, BSI Inc., since
1993. Today, he's responsible for BSI's Conformity Assessment
Body and IVD Notified Body activities. Letters to the editor
regarding this article should be e-mailed to letters@qualitydigest.com.
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