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MDD, the Medical Device Directive
93/42/EEC - Introduction
There are three directives for medical devices:
The following exposition refers to the MDD, although most provisions
are much the same under the other two medical device directives.
Under the MDD a 'medical device' is defined as any instrument,
apparatus, appliance, material or other article, whether used alone or in combination,
including software necessary for its proper application intended by the manufacturer to be
used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic means, but which may be assisted
in its function by such means.
An 'accessory' means an article which whilst not being a device is
intended specifically by its manufacturer to be used together with a device to enable it
to be used in accordance with the use of the device intended by the manufacturer of the
device.
'Manufacturer' in the sense of the Medical Devices Directives means the
natural or legal person with responsibility for the design, manufacture, packaging and
labeling of a device before it is placed on the market under his own name, regardless of
whether these operations are carried out by that person himself or on his behalf by a
third party.
All medical devices must meet the applicable ‘essential
requirements’ on safety, performance and labeling as outlined in Annex I of the MDD.
Safety requirements are not restricted to patients but include users and, where
applicable, other persons. The fulfillment of the essential requirements has to be
demonstrated by the manufacturer for all devices whether they are new devices or whether
they have already been on the market in former times. Under the MDD there are no
provisions for a "grandfathering" approach as known for example in the US.
Labeling may be and in general is required by each Member State in its
national language(s); the use of symbols is recommended.
Medical devices are classified in accordance with Annex IX of the MDD.
The classification determines which conformity assessment procedure the manufacturer must
follow in accordance with the Annexes II, III, IV, V, VI and VII of the MDD
Regardless of the class a
device belongs to, the manufacturer is obliged to maintain a 'technical file', for the
respective device or device family. Moreover, it is his responsibility to issue and keep
on file 'declarations of conformity' for his CE-marked devices. For custom-made devices
and devices intended for clinical investigations the manufacturer must draw up a
‘statement concerning devices for special purposes’ according to Annex VIII.
As a general rule, confirmation of conformity with the requirements
concerning the characteristics and performances under normal conditions of use of the
device and the evaluation of the undesirable side-effects must be based on 'clinical
data'. This applies in particular to implantable devices and devices in class III.
According to Annex X, the clinical data must be based on:
- either a compilation of the relevant scientific literature currently available on the
intended purpose of the device and the techniques employed as well as, if appropriate, a
written report containing a critical evaluation of this compilation;
- or the results of all the clinical investigations conducted.
For clinical investigations the rules laid down in Article 15 and Annex
X of the MDD apply and the performance of clinical trials is recommended to follow the
standard EN 540.
Here the Notified Bodies Recommendations NB-MED/2.7/Rec 1 ‘Guidance on clinicals’ and NB-MED/2.7/Rec 3 ‘Evaluation
of clinical data’ are helpful.
MDD, Article 14.2 rules that, where a manufacturer without a registered
place of business in a Member State of the EU places class I or custom-made devices on the
EU market, he shall designate a 'responsible person' who is established in the Community
(e.g. authorized representative). This person shall inform the 'Competent Authorities' of
the Member State of the address of the registered place of business and the category of
devices concerned. Furthermore the label or the outer packaging, or instructions for use
shall contain in addition the name and address of either the responsible person or the
authorized representative of the manufacturer established within the Community or of the
importer established within the Community. These persons are also obliged to the duties
concerning the storage of the ‘technical file’.
Since 14 June 1998 no medical device covered by the MDD 93/42/EEC shall
be placed on the market that does not carry a CE mark. 'Placing on the market' means
making available in return for payment or free of charge of a device other than a device
intended for clinical investigation, with a view toward distribution and/or use on the
Community market, regardless of whether it is new or fully refurbished.
For 'putting into service' devices without CE-mark there has been an
extended transition period until 30 June 2001. Putting into service means the stage at
which a device has been made available to the final user as being ready for use on the
Community market for the first time for its intended purpose.
The only devices not requiring a CE-mark are 'custom-made devices' and
'devices intended for clinical investigations', where the manufacturer must keep
documentation in accordance with MDD Annex VIII. Custom-made device means any device
specifically made in accordance with a duly qualified medical practitioner's written
prescription which gives, under his responsibility, specific design characteristics and is
intended for the sole use of a particular patient.
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