Gość: PABLO
IP: *.kamir.com.pl
11.03.03, 11:07
W zwiazku z dostosowywaniem naszego prawa do standardow
UE napotkałem w swojej branży już poważne problemy
związane z oznakowaniem CE (przypominam iż od grudnia
tego roku żaden wyrób medyczny nie posiadający tego
znaku nie będzie mógł byc sprzedawany na terenie Polski
- niezaleznie czy wejdziemy do UE czy nie tak bowiem
stanowi Ustawa o wyrobach medycznych).
I tak wlasnie wygląda Unia od strony praktycznej co
polecam takim durniom i teoretykom ekonomii jak pan
kimmjiki. Siedze i przedzieram sie przez gąszcz
przepisów (np. nie sposób znalesc katalogu UMDNS wg
którego trzeba rejestrowac produkt - no można kupic ten
katalog i słono zapłacić) UNIA JEST SUPER!!!!
Polecam artykuł na temat:
CE MARKING
too burdensome for small manufacturers?
By: Hans Haindl
With the support of highly capable regulatory affairs
departments, large international medical device
manufacturers experience little difficulty in complying
with the complicated regulations governing the sale and
distribution of medical products in Europe. Moreover,
through their work with lobbyists and their contact
with industry organisations such as the European
Confederation of Medical Devices Associations
(EUCOMED), they have the ability to influence, albeit
indirectly, the legislative process, thereby ensuring
that their concerns are addressed.
But what about small and medium manufacturers — the
companies with sufficient sales volumes across the
European Union (EU) to warrant its ‘CE’ certification
but lacking a registered place of business or a
subsidiary in any member state? These manufacturers
without the same clout or resources at their disposal,
will discover that their concerns are generally
overlooked. In addition, these smaller manufacturers
face difficulties with CE certification and
registration not faced by their much larger competitors.
CE REGISTRATION
Certification and registration procedures often follows
a similar pattern. The minimum requirement for CE
marking is through the self-certification process,
(Class I devices). Regardless of device classification
or whether a notified body was involved, every
manufacturer must fulfil both the essential
requirements in accordance with Annex 1 and complete a
Declaration of Conformity in accordance with Annex VII.
Foreign manufacturers, without a registered place of
business in the EU, must then apply for CE registration
via an authorised representative in accordance with
Article 14.2 of the Medical Device Directive
(93/42/EEC). Following the recent publication of the in
vitro diagnostic Directive (IVDD), 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
manufacturer with regard to hte latter’s obligations
under this Directive.’ (Directive 98/79/EC, Article 1,
§2g). The registration is performed using the DIMDI
(German Institute for Medical Documentation and
Information) databank system. Unfortunately, this
system can only be used to register either the
manufacturers (providing they have a registered place
of business in the EU) or their authorised
representatives — but not both of them. Thus, in the
case of non-European manufacturers, it is the
authorised representatives who will receive
confirmation of registration and not the manufacturers
for whom they work.
Registration using the DIMDI databank system demands a
familiarity with the Universal Medical Device
Nomenclature System (UMDNS), which provides a common
basis for device classification. Although UMDNS codes
offer numerous advantages, as they reflect not only
product categories but also subcategories, they
unfortunately cause a lack of transparency. A
manufacturer of a simple knee brace, for example, could
register the device under UMDNS code 12-837, Orthoses,
or UMDNS code 17-874, Orthoses, Knee, and should the
manufacturer have a broad range of orthotic devices, it
may have to use as many as nine different codes.
An additional hurdle is that registered trade names and
trade marks lack authority and most devices are not
reflected in the coding system in such a way as to
alleviate the fears and uncertainties of distributors
and end-users. Products that are broadly recognised in
the United States, for example, will still receive
scrutiny in the EU. Larger manufacturers are rarely
asked to provide their European distributors or
end-users with proof of CE compliance and they are
seldom called upon to provide evidence of registration.
On the other hand, small foreign manufacturers working
via an authorised representative are requested to
provide this evidence. This presents a predicament: how
can they provide appropriate evidence of registration
and compliance when they themselves are not reflected
in the DIMDI databank system and do not receive a
transparent confirmation of registration?
Unfortunately negotiating the DIMDI maze is not the
only obstacle a small manufacturer must face. After
successfully completing a suitable conformity
assessment procedure in accordance with the relevant
directives, the manufacturer must then gather the
various directives, standards and guidance documents
needed to demonstrate compliance. This proves to be a
daunting task as the guidelines and official documents
published by the European Commission are distributed by
numerous institutions and organisations who also make a
substantial charge.
A possible solution to these obstacles would be the
creation of a central website, based on the website of
the US Food and Drug Administration (FDA). Not
particularly user-friendly the EU website lacks the
open transparency that the FDA website provides.
MAINTAINING COMPLIANCE
Final compliance with the relevant directives does not
mean that the finishing line has been crossed.
Standards are revised constantly and those
manufacturers who do not actively take part in these
revisions — or have regulatory affairs officers to
track them — will find it nearly impossible to keep
up-to-date. Consequently, small manufacturers are often
found to be non-compliant during re-auditing as the
documents they are using have been superseded.
Regular meetings of notified bodies are held in order
to exchange experiences and issue recommendations
regarding grey areas that have come to light within the
Directives. However, although these recommendations
have little or no legal standing within the EU and are
not published, they have a significant impact on the
conformity assessment procedure. Mistakes regarding
simple classification issues inevitably lead to
non-compliance and will result in a complete change in
such areas as labelling and packaging. For example,
what is the exact definition for a Class 1 device with
a measuring function? Are simple urine drainage bags
with graduation marks Class 1 or Class 1 with measuring
function? The same question applies to small plastic
beakers and spoons for administering medicines.
Moreover, these questions are still being discussed,
even though the transition period has long since gone.
A large percentage of medical devices distributed
within the EU are designed and manufactured by small
overseas companies, but if the competent authorities
fail to understand the unique needs of these
manufacturers, there is a risk that an important source
of medical supplies will be lost. The elimination of
both physical and conceptual trade barriers was a
founding principle of the EU, but the existence of a
system that presents virutally insuperable barriers to
for foreign manufacturers cannot be said to uphold that
admirable goal.
