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The IVDD

The Next EU Hurdle

Ever hear the saying, "He who laughs last, get the best laugh!" Well, it seems that the medical device industry seems to be having the last laugh over the in-vitro diagnostic industry.

While the medical industry was struggling with the Medical Device Directive to assure that they could comply with the CE requirements, the In-Vitro Diagnostic industry just sat back and watched. Well, now their time has come.

The requirements to putting the CE mark on In Vitro Diagnostic products is now being finalized. From all information that has been published it seems now that the IVD Directive (IVDD) shall start with the new millennium. There will be a period of one year for the member states to implement the Directive and to transpose it to national law. After the year the Directive will be force. As there was with the MDD, a transition period of about 3 1/2 years will be in place and with taking that all into account, it will be about the year 2004 for the IVDD to be enforced.

It appears based on that fact that the number of In Vitro Diagnostic companies are smaller than those covered by the MDD - it is highly unlikely that there would be an additional transition period like the one given for the MDD, for the products already in the trade chain.

When you evaluate the IVDD requirements the situation is completely different as compared to the situation with the MDD. The market for most medical devices was more or less non-regulated in most European countries. This meant that with the MDD for the majority of medical device manufacturers was additionally hazy, good to avoid as long as possible.

Most of the IVDs were already covered by national drug legislation tremendously reducing the effort for launching an IVDD. So while complying with the MDD, medical device manufacturers were faced with a very complicated set of procedures, but for most IVD manufacturers the IVD Directive means simplification.

So waiting until the last minute to put the CE mark on your IVD, like the medical device industry did would not make good sense. In fact, there are many good reasons to get a jump on the situation and to start marketing IVDs with a CE mark from the very first day.

As with the MDD the IVDD tries to rule a tremendous range of products with one regulation. The scope goes from a simple test strip for glucose or a vial for blood specimens on the one end to an automatic multi-analyser on the other end. General laboratory equipment is not covered. But, as it they are specifically used for diagnostic purposes they fall under the Directive. As with the MDD, the question whether a product is covered or not by the Directive, is answered by the intended purpose.

The IVDD was formulated with the perception that the risk associated with most IVDD products is relatively low because the way they are used does not involve contact with the patients. As a matter of fact, the users are normally qualified and professional. The way of regulating the IVD industry is more or less the same as with the MDD. There are essential requirements and there are conformity assessments. Unfortunately, the Annexes' numbers do not mean the same as the numbers in the MDD. There will be a vigilance system for IVDs in European and there will be notified bodies, but it will be required less often than for the MDD. As with medical devices, there must be an Authorized Representative for non-European manufacturers.

The IVDD makes it mandatory for all IVD manufacturers to keep a quality system, but it will not be mandatory for most of the IVD Directive to have the quality system certified. Annex II has two lists, a list A and B of products that need certification.

All products must meet the essential requirements of Annex I as in the MDD, though this compliance seems to meet similar requirements found in a 510(k) submissions for these products.

Notified Body Involvement

Annex II defines criteria for the involvement of notified bodies for certain products. The conformity assessment procedures are described as well as the registration necessities of the manufacturers and devices which is very similar to that of the MDD. As with the MDD, an European addresses would be necessary for non European IVD manufacturers. There is a vigilance system and a European data base. The member states will have the right to possibility to prohibit products for limited time for health and safety reasons.

There are rules for the designation and surveillance of notified bodies. The way of CE marking and the obligation if CE mark is wrongly applied. And there are notifications in case of restriction of products. The member states have to observe confidentiality and they have to co-operate, which we hope will not just be a wish but reality. IVDD also has some final implementation for the Medical Device Directive. There are eleven Annexes.

The products requiring the Notified Body involvement must conform to a common technical specification (CTS) as well as have a full quality assurance system. For these products there must be a design examination by a notified body. For some of the products there is the possibility for the notified body to control batch release or if there is no full quality assurance system there must be an EC type examination plus the possibility for the notified body to control batch release. Additionally all products for patient use have to be reviewed by the notified body regarding the clarity of understanding in the product information.

For reagents, reagent products, reference and control materials the manufacturer shall notify competent Authorities with all information concerning common technological characteristics and/or analytes as well as any important subsequent modification (especially market withdrawals). For all other IVDs the manufacturer shall inform the Competent Authority on the appropriate indications.

The IVD manufacturers should take a hard look at the lessons learned by their counterpart, the medical device manufacturers, as they tried to comply with the MDD requirements to assure continued uninterrupted assess to the European market.

The IVDD is out now. The time to comply is now - not later. If you plan to distribute IVDs into the European Community into the 21st Century, making sure you comply with a Directive that is not going to disappear, only makes sense to your company's marketing plan. Waiting could cause competitive problems that may not be easy to erase. So far after reviewing this IVDD, it appears that if the IVD industry takes it more seriously than the medical device industry took the MDD, then in reality the IVD industry will have the last laugh.

I want to thank Dr. Han Handel, MDSS for his contribution to this Insight Report.

Next Insight - The QSIT - Really, what has the FDA changed?

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