mdi’s Germany affiliate MDSS has been keeping an eye on the CE mark situation in the European Community. It appears that there appears to be some problems still associated with pre-CE mark products still in distribution in the EU. Here is an update on this situation.

There are signs, however, that most countries have been swayed by the European Commission’s latest position, which aims to settle the matter once and for all. Most countries now appear ready to accept these products, but under conditions which vary from country to country.

Problems have arisen because many understood that the EU Medical Devices Directive (MDD), which came into full effect on June 14, effectively prevented the sale and transfer of devices which had been manufactured under national rules and were ready for market - but not actually in use (or distribution channels) - before the deadline.

Industry pressure resulted in the Commission drafting a proposed change to the forthcoming In Vitro Diagnostics (IVD) Directive. This was intended to amend the MDD to allow non-CE-marked products, manufactured according to earlier national regulations, be allowed to continue in the distribution chain until June 2001.

However, industry remained concerned. The IVD Directive amendment had no legal status until the legislation was adopted (it still requires final adoption) and its text, including the amendments to the MDD, implemented in national law (not due until mid to late 1999).

In an attempt to clarify the matter, the Commission issued a Communication, which confirmed that all non-CE-marked medical devices on the market in the European Economic Area (EEA) and ready for use could still be transferred, sold and used. Although an earlier working document spoke of a June 2001 deadline, no actual date is specified in the Communication. This latest document, which has no legal status, has generally been welcomed by both the industry and regulators.

Most countries now accept non-CE-marked medical devices that were made available for sale within their own borders by the June 14 deadline. But it is debatable whether these products can be sold or transferred to other EEA countries.

EACH EU MEMBER MAKES UP THEIR OWN MIND

Sweden will not longer accept any non-CE-marked products from other EEA countries, nor will it allow the export of such products from Sweden to other European countries. It argues that other countries should do the same to ensure the EEA has watertight defenses against a potential invasion of non-CE-marked products of dubious origins.

Austria will not accept non-CE-marked products either and will only accept such products that were in the country before June 14 and complied with Austrian regulations. Denmark, however, is prepared to accept these products. The UK, Ireland and Norway admit they are still uncertain, but fear becoming a "dumping ground" if they accept products which other EEA countries have rejected.

Some observers believe the Commission statement introduces further confusion. Its Communication does not mention at which stage in the distribution chain a device is considered eligible. Once again interpretations vary. Many argue, for example, that the manufacturer’s warehouse should be included. Denmark insists that the product must be "physically transferred from the manufacturer to an Swedish distributor or Swedish end-user". Austria is even more specific, insisting that the device must e in a hospital, or in store or being used by the end-user. The UK’s position is unclear.

Despite previous uncertainty on the issue of non-CE-marked devices, it is clear member states are broadly falling into line with the Commission’s communication. Italy and Ireland have now accepted it and have come on board. Germany was already willing to allow non-CE-marked medical devices to be sold until mid-2001 and published legislation to that effect in late-1997.

France remains the odd one out. Until last month, it had argued that the text of the Directive still stood until there was a legal alternative. However, its position is changing slightly, At the time of writing (this article), the Government was on the point of issuing a circular stating that it would consider on a case-by-case basis whether to allow non-CE-marked products to be sold on. This would only partly depend on the volume of devices sold. France also has a general policy preventing Class III (high risk) and IIb (medium risk) implantables to be transferred or sold on, except in cases where there are no clinical alternatives.

France intends to treat non-CE-marked products from elsewhere in the EEA in the same way as products in its own market by this date.

So Where does this leave non-CE mark Products?

If purchasers now insist on accepting only CE-marked products, the debate over the finer legal points of the Directive will be only theoretical. This will leave these products in the warehouse or being returned to the original manufacturer for sale in some other country.

Unfortunately, if this is the case, many companies will have learnt a hard lesson by not getting the CE-marking earlier.