A
Regulatory Primer (Part 3): Up Close:
The European Rules-Based System
In the first
part of this series,Roger
Gray of Donawa Consulting
explained how device classification can play an important
role in determining not only the quickest route to market,
but also, potentially, in which of the major markets, United
States (U.S.) or Europe (EU), the product is likely to achieve
first clearance for sale.
In part 2, Roger looked at
classification issues in the United States in greater detail.
This
article provides detail on the European classification system.
His first words of advice: Determine device classification as early
as possible.
The European system is "rules-based,"
making the manufacturer responsible for determining the
classification of its own devices. Although the rules
are written in a numerical sequence, they can be considered
as a decision tree -- indeed, the official European
guideline to applying the classification rules, MEDDEV
2.4/1, includes a set of flowcharts to aid manufacturers
in reaching the correct classification decision.
In contrast,
the U.S. Food and Drug Administration (FDA) system assigns
a classification to each type of medical device within
three classes, where Class I is the lowest risk category
and Class III the highest. A database on the FDA website
allows manufacturers to determine the relevant classification
of their devices.
Similar to the U.S. system, medical devices in Europe
are classified in four classes, depending on the degree
of perceived risk:
Class I: Lowest
risk
Class IIa: Intermediate
risk
Class IIb: Higher intermediate risk
Class III: Highest
risk
Although active implantable devices are covered
by their own directive, for the purposes of this
overview, they can be considered as Class III devices.
In vitro diagnostic devices are categorized in a
different manner and will be covered in a later
article.
The class of a device also
provides manufacturers with a choice of routes
to market ("conformity
assessment routes"), as will become apparent.
In common with the FDA system, increasing perception
of risk brings with it an increased scrutiny prior
to a device being allowed onto the European market.
Essentially, under the Medical Devices Directive
(93/42/EEC) (MDD), Class I devices may be CE marked,
in a self-declaration process, according to Annex
VII of the MDD (EC Declaration of Conformity)
once the manufacturer has satisfied itself that
the Essential Requirements (ERs)
contained in Annex I of the MDD have been met.
A Notified Body
Third-party oversight, from a Notified
Body (NB) designated by one of the EU member states,
is necessary for Class I devices only if they are marketed
as sterile devices, or if they have a measuring function.
Even then, the NB activity is limited to those
particular aspects of the device.
For devices in Classes
IIa and IIb, involvement of an NB is mandatory, either
to
(1) assess the manufacturer’s
quality system against the requirements of Annex II
(full quality assurance, with similar requirements to
ISO 13485), Annex V (production quality assurance) or
Annex VI (product quality assurance); or
(2) verify that
devices have been "type tested" and conform
to a specified device design, Annex III (EC type examination);
(3) or
that the each device or batch of devices are tested
before release to market, Annex IV (EC verification).
Manufacturers
of Class IIa devices may also use Annex VII, as long
as either Annex V or Annex VI has been additionally
selected for quality system certification. In contrast,
Annex VII cannot be used by manufacturers of Class IIb
devices because of their higher risk category.
An NB must also be involved in the CE marking process
of Class III devices in two different ways:
(1) The
manufacturer may choose to apply to a NB for certification
of its full quality assurance system (Annex II), but
must also submit a "design dossier" for
NB review and approval (Annex II section 4); or
(2)
it can go through the type-testing process (Annex III)
coupled with the EC verification process (Annex IV)
or the certification of its production quality system
(Annex V). This effectively means that Class III device
design is subject to a formal evaluation before the
product can be marketed.
Areas of Applications
The rules-based European classification system divides
devices into a number of areas of application, based
on the level of invasiveness and duration of use, but
then has additional rules for "active" devices (devices whose operation depends on any source of power
other than that directly generated by the human body or
gravity, and which acts by converting this energy), and
certain other product types, such as combination devices,
contraceptives, and blood bags, plus breast implants and
certain orthopaedic implants which were reclassified into
Class III by Directives 2003/12/EC and 2005/50/EC.
If two different rules are found to apply to a device,
then the rule resulting in the higher classification
must be used.
Comprehensive guidance to application of the classification
rules, including examples, is provided in the
MEDDEV document 2.4/1.
Manufacturers
should include a classification rationale within the
technical documentation retained for each device type.
Making the Complex Simple
To the uninitiated, the choice of routes
through the conformity assessment system may seem bewilderingly
complex, so a diagrammatic representation is often used
to help manufacturers determine the options available
(see Table 1 below).
Table 1: European conformity assessment
routes for medical devices
In terms of
timescales, if a Class I manufacturer considers compliance
with the appropriate European directive at the beginning
of the design process, taking the relevant ERs
into account at each stage of development, the CE marking
process and the automatic market clearance that goes
with it can be achieved relatively quickly.
If
an NB needs to be involved, it is best to select one
as early as possible, to allow time for a pre-audit
visit to assess the readiness of either the manufacturer’s
quality system and type-testing route to market.
For Class III devices needing design dossier examination
or type testing, it is advisable to obtain timescale
estimates from a number of potential NBs before making
a selection.
The next article in the series will cover
quality systems – comparing the U.S. and European
approaches.
About the author:Roger
Gray holds a B.Sc. in mechanical engineering and
is Director, Global Regulatory Affairs at Donawa
Consulting (Rome, Italy), where he is responsible for assisting
medical technology clients obtain marketing clearance
for both Europe and the USA, in addition to managing
the company’s
European Authorized Representative portfolio. He has
over 25 years' experience in the device industry and
was involved with the development of the Medical Devices
Directive during its formative stages.
