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Archive: 1999 News in Regulatory Affairs Archive

1. IVD Directive Passed
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.:

    • EN 375 - information supplied by the manufacturer with in-vitro diagnostic reagents for professional use
    • EN 376 - information supplied by the manufacturer with in-vitro diagnostic reagents for self-testing
    • EN 591 - user manuals for in-vitro diagnostic instruments for professional use
    • EN 592 - user manuals for in-vitro diagnostic instruments for self-testing
    • ER/EN 1658 - standards for the requirements for the marking of in-vitro instruments

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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