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CE/MDD 최단기간 인증취득 안내! 

ISO13485:2003 최단기간 인증취득 안내!

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 September 2007
amending Council Directive 90/385/EEC on the approximation of the laws of the Member States
relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical
devices and Directive 98/8/EC concerning the placing of biocidal products on the market.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and
Social Committee (1),
Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),
Whereas:
(1) Council Directive 93/42/EEC (3) requires the Commission
to submit a report to the Council, no later than five years
from the date of implementation of that Directive,
concerning: (i) information on incidents occurring following
the placing of devices on the market, (ii) clinical
investigation carried out in accordance with the procedure
set out in Annex VIII to Directive 93/42/EEC, and (iii)
design examination and EC type examination of medical
devices that incorporate, as an integral part, a substance
which, if used separately, may be considered to be a
medicinal product as defined in Directive 2001/83/EC of
the European Parliament and of the Council of 6 November
2001 on the Community code relating to medicinal
products for human use (4) and which is liable to act upon
the body with action ancillary to that of the device.
(2) The Commission brought forward the conclusions of that
report in its Communication to the Council and the
European Parliament on medical devices which, at the
request of the Member States, was expanded to cover all
aspects of the Community regulatory framework for
medical devices.3 June 2003 adopted a resolution on the health
implications of Directive 93/42/EEC (6).
(4) Following from the conclusions drawn in that Communication
it is necessary and appropriate to amend Council
Directive 90/385/EEC (7), Directive 93/42/EEC and Directive
98/8/EC of the European Parliament and of the
Council (8).
(5) To ensure consistency of interpretation and implementation
between Directives 93/42/EEC and 90/385/EEC the legal
framework related to issues such as authorised representative,
the European databank, health protection measures,
and the application of Directive 93/42/EEC as regards
medical devices incorporating stable derivates of human
blood or human plasma, as introduced by Directive 2000/
70/EC (9), should be extended to Directive 90/385/EEC. The
application of the provisions on medical devices incorporating
stable derivates of human blood or human plasma
includes application of Directive 2002/98/EC of the
European Parliament and of the Council of 27 January
2003 setting standards of quality and safety for the
collection, testing, processing, storage and distribution of
human blood and blood components and amending
Directive 2001/83/EC (10).
(6) It is necessary to clarify that software in its own right, when
specifically intended by the manufacturer to be used for one
or more of the medical purposes set out in the definition of
a medical device, is a medical device. Software for general
purposes when used in a healthcare setting is not a medical
device.

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