Archive: Companies scramble for CE-Mark
Companies may scramble to gain CE mark when the new IVD Directive comes into force
In vitro diagnostic companies in Europe may have even less time than they expect to CE-mark their products once the new IVD Directive comes into force next year.Technically, they have from June 7/2000 to December 7 /2003 to affix the CE mark to their products, but the real transition period could be much shorter than the three-and-a-half years allowed.
Healthcare purchasers are now much more aware of the meaning and importance of the CE mark following the enactment of the other two medical device directives. IVD companies with non-CE-marked products may soon find themselves at a competitive disadvantage in hospital tenders, for example, with hospitals favouring products with the CE mark over those without.
Only companies with niche products or products with few competitors can afford not to follow the European route early on. But such companies are few and far between in the highly competitive European IVD market.
During the transition period, companies can follow either the national approval route or the European route. Only the latter allows them to affix the CE mark, either after self-certifying (in the case of low-risk diagnostics) that the product complies with the directive requirements or, with higher-risk products, following involvement with one of the notified bodies (NBs), the third-party certification bodies authorised to carry out conformity assessment procedures.
Member states technically have until the end of the year to transpose the directive into national legislation, although there is a six-month " buffer zone " before the directive comes into force. Until the directive is transposed, member states cannot nominate organisations to act as NBs. This, however, should not deter companies from engaging with those outfits which are likely to be named.
One reason for this is that there will probably only be a small number of designated NBs (possibly including well-known names such as PEI, Lloyds, TUV PS, and ADM) and so waiting lists are likely. In the run-up to the full implementation of the Medical Devices Directive (MDD) in June last year, the notified bodies were so busy that were waiting lists of up to four months. 8, 10, 15 NBs might be named under this latest directive - what is certain is that there will be far fewer than the 55-60 designated under the MDD. Between 15 and 17 are designated under the Active Implantable Medical Devices Directive.
This time round, the competent authorities will be highly selective when it comes to designating notified bodies. With the MDD, there was a rush to become an NB. Some competent authorities were " lighthearted " in approving them with the result that some medical devices were launched which should not have been on the market. The situation was corrected quite quickly and is now fairly good. Some NBs pulled out, others acquired new skills and people, but apparently none were de-certified.
Another reason to liaise with potential NBs at this stage, is that there are many grey areas in the IVD Directive and it is vital for companies to understand how the NBs will interpret these. Only CE-marked IVDs can be "placed on the market" after December 7/2003. For an additional two years, however, non-CE-marked IVDs that were placed on the market during the transition period can continue to be "put into service", i.e. made available to the final user.
The IVD Directive has ramifications for the MDD. Member states, for example, will be able to require manufacturers to register certain higher-risk devices (specifically Class IIb and Class III devices) with the competent authority in those countries where the products are marketed. Under the original MDD, manufacturers need register only Class I (low-risk) devices, i.e. those products which can be CE-marked by the manufacturer with no notified body involvement.
At least one member state - the UK - is currently looking at the costs this change would involve. It is up to each member state to decide how to transpose the. At this stage, it is not at all clear that the UK will take up the option.