Confusion remains over
legal status of
non-CE-marked products in Europe
The fate of Non CE-marked devices,
distributed in Europe close to the June 15 deadline for CE marking, remains in limbo.
There are signs, however, that most countries have been swayed by the
European Commission’s latest position, which aims to settle the matter once an 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 - 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. 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 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 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.
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 be 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 taken it on board. Germany was already willing
to allow non-CE-marked medical devices to be sold until mi-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.
If purchasers now insist on accepting only CE-marked products, the
debate over the finer legal points of the Directive will be only theoretical. In this
case, many companies will have learnt a hard lesson by leaving CE-marking late.
Return To Previous Page
|
