The IVD Directive 98/79 EC has passed the European Council in
1998. After many years of arguing, now the schedule for the
enforcement of the IVD is clear. The member states had to transpose it
to national laws before December 7, 1999.
Starting June 7, 2000, the CE-mark may be affixed. But there could
arise the situation that to that date no Notified Body is available.
Many Notified Bodies regard the market as too small for activities in
the IVD sector.
There are already some standards or pre-standards for the detailed
implementation of the IVD Directive, e.g.:
2. Entry Fees for the European Market?
Regarding the registration of IVD manufacturers in some European
countries, the idea came up to have a tax for the registration of IVDs.
No idea is stupid enough not to be discussed.
3. Clarification of the Role of the Authorized Representative
With the publication of the IVD Directive the role of the European
representative has been clarified officially. Because this
clarification reflects exactly the understanding that MDSS has had and
emphasized since 1995, there are no consequences or alterations for
our customers.
4. Belgium starts a New Discussion on Re-Use of Single-Use
Products
Belgium has started an initiative to force manufacturers to prove that
the re-use of a product claimed as single-use product is not possible.
This is a new chapter of a never ending story - it comes and goes like
the flu.
5.France Going Crazy France
wants to establish additional controls and national registration
for high risk medical devices. Especially manufacturers of animal
derived devices are going through bad times in France at the moment.
6. Court Trials on the CE-Marking of Tooth Whiteners in Several
European Countries
Court decisions in UK and Germany forced manufacturers of tooth
whiteners to withdraw their CE-Marks. The reason is that they didn't
state a medical indication. Just getting brilliant white teeth is not
an intended purpose that makes the product a medical device. Other
manufacturers of the same products won't have these problems because
they clearly state medical intended purposes like bleaching
tetracycline residues in teeth.
7. Requests for Product Files from Local Authorities
The discussions on teeth whiteners were reason for many local
authorities in Europe to have a test run of the requirement that an
authorized representative has to provide the authorities with the
product documentation. The result was that a significant number of
companies were not able to provide the technical documentation within
an acceptable time.
8. New ISO Standards
The ISO 9000 standards are in an update phase to ISO 9000-2000. These
presently exist as draft version, but many registrars and consultants
already work with the new standard. The additional European standards
EN 46000 ff. will become ISO standards. Also the European standard on
risk analyses EN 1441 will be harmonized and maybe succeeded by ISO
14971. There will be a new standard on symbols and abbreviations.
9. Directive for Metric System
The directive for the metric system has been postponed for
10 years. During this transition period it will be allowed to have
metric dimensions and American units on the same label.
February 15, 2000
Hans Haindl
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