Amendments to the European Medical
Device Directive MDD 93/42/EEC
The publication of the In Vitro Diagnostic Directive (IVDD)
98/79/EC in December 1998 introduced certain amendments to the MDD 93/42/EEC.
These amendments are outlined
in Article 21 of the IVDD, namely as follows:
(a) in Article 1(2):
modification to the definition of an IVD
- point (c) shall be replaced
by the following:
'(c) "in vitro
diagnostic medical device" means any medical device which is a reagent, reagent
product, calibrator, control material, kit, instrument, apparatus, equipment or system,
whether used alone or in combination, intended by the manufacturer to be used in vitro for
the examination of specimens, including blood and tissue donations, derived from the human
body, solely or principally for the purpose of providing information:
- concerning a
physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices.
"Specimen receptacles" are those devices, whether vacuum-type or not,
specifically intended by their manufacturers for the primary containment and preservation
of specimens derived from the human body for the purpose of in vitro diagnostic
examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless
such products, in view of their characteristics, are specifically intended by their
manufacturer to be used for in vitro diagnostic examination;'
(a) in Article 1(2):
modification to the definition of 'Putting into Service'
- point (i) shall be
replaced by the following:
'(i) "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;'
(a) in Article 1(2):
definition of 'Authorizied Representative'
- the following point shall
be added:
'(j) "authorised
representative" means any natural or legal person established in the Community who,
explicitly designated by the manufacturer, acts and may be addressed by authorities and
bodies in the Community instead of the manufacture r with regard to the latter's
obligations under this Directive;'
(b) Article 2:
definition of 'Placing on the Market and Putting into Service'
'(b) Article 2 shall be
replaced by the following:
' Article 2
Placing on the market and
putting into service
Member States shall take
all necessary steps to ensure that devices may be placed on the market and/or put into
service only if they comply with the requirements laid down in this Directive when duly
supplied and properly installed, maintained and used in accordance with their intended
purpose.'
(c) Article 14(1):
request for information concerning class IIb and III devices from Member States
(c) the following paragraph
shall be added to Article 14(1):
'For all medical devices of
classes IIb and III, Member States may request to be informed of all data allowing for
identification of such devices together with the label and the instructions for use when
such devices are put into service within their terr itory.'
(d) Article 14:
(d) the following Articles
shall be inserted:
European Databank
'Article 14a
European databank
1. Regulatory data in
accordance with this Directive shall be stored in a European database accessible to the
competent authorities to enable t hem to carry out their tasks relating to this Directive
on a well-informed basis.
The databank shall contain the
following:
(a) data relating to
registration of manufacturers and devices in accordance with Article 14;
(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or
refused according to the procedures, as laid down in Annexes II to VII;
(c) data obtained in accordance with the vigilance procedure as defined in Article 10;
2. Data shall be forwarded in a standardised format.
3. The procedures implementing this Article shall be adopted in accordance with the
procedure laid down in Article 7(2).'
Health Monitoring
Measures
Article 14b
Particular health
monitoring measures
Where a Member State considers, in relation to a given product or group of products, that,
in order to ensure protection of health and safety and/or to ensure that public health
requirements are observed pursuant to Article 36 of the Treaty, the availabil ity of such
products should be prohibited, restricted or subjected t o particular requirements, it may
take any necessary and justified transitional measures. It shall then inform the
Commission and all the other Member States giving the reasons for its decision. The
Commission shall, whenever possible, consult the interes ted parties and the Member States
and, where the national measures are justified, adopt necessary Community measures in
accordance with the procedure referred to in Article 7(2).'
(e) Article 16: Suspension or Withdrawl of Certificates by Notified Bodies
(e) the following paragraphs
shall be added to Article 16:
'5. The notified body shall
inform the other notified bodies and the competent authority about all certificates
suspended or withdrawn and, on request, about certificates issued or refused. It shall
also make available, on request, all additional relevant information.
6. Where a notified body
finds that pertinent requirements of this Directive have not been met or are no longer met
by the manufacturer or where a certificate should not have been issued, it shall, taking
account of the principle of proportionality, suspe nd or withdraw the certificate issued
or place any restrictions on it unless compliance with such requirements is ensured by the
implementation of appropriate corrective measures by the manufacturer. In the case of
suspension or withdrawal of the certificate or of any restriction placed on it or in cases
where an intervention of the competent authority may become necessary, the notified body
shall inform its competent authority thereof. The Member State shall inform the other
Member States and the Commission .
7. The notified body shall, on
request, supply all relevant information and documents including budgetary documents,
required to enable the Member State to verify compliance with Annex XI requirements.'
Please note that the original
text of the 98/79/EC directive should instead read......'compliance with Annex IX requirements'.......
instead of the mistaken......'compliance with Annex XI requirements'
(f) Article 18:
Wrongly Affixed CE Marking
(f) the following paragraph
shall be added to Article 18:
Those provisions shall also
apply where the CE marking has been affixed in accordance with the procedures in this
Directive, but inappropriately, on products that are not covered by this Directive.'
(g) Article 22:
Extension of Period
(g) in Article 22(4), the
first subparagraph shall be replaced by the following:
' 4. Member States shall
accept:
- devices which conform to the
rules in force in their territory on 31 December 1994 being placed on the market during a
period of five years following the adoption of this Directive, and
- the aforementioned devices being put into service until 30 June 2001 at the latest.'
(h) Notified Body
Information Exchange
(h) Annex II, section 6.2,
Annex III, section 7.1, Annex V, section 5.2 and Annex VI, section 5.2 shall be deleted;
(i) Notified Body'
Scientific Staff
(i) in Annex XI, section 3 the
following sentence shall be inserted after the second sentence:
'This presupposes the
availability of sufficient scientific staff within the organisation who possess experience
and knowledge sufficient to assess the medical functionality and performance of devices
for which it has been notified, having regard to the r equirements of this Directive and,
in particular, those set out in Annex I.'
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