Review of medical devices legislation in the making

Days before the publication of the first draft
of the reviewed medical devices directive, a Commission expert
set out the state of play to industry

A Commission expert speaking at a Technical Forum,
organised by the Medical Technology Industry Association
(Eucomed), set out the main issues in this review and
their state of play, on 29 September 2004. Some of the
main points he mentioned were:

  • There will be no radical overhaul of the active
    implantable medical devices directive
  • It is still undecided whether software necessary
    for the functioning of a medical device should be
    covered by the new directive.
  • Classification anomalies, e.g. loopholes where
    medical devices do not get classified would be
  • Electronic labelling, i.e. the possibility of
    providing instructions in electronic rather than paper
    format, is being considered (currently, the mention of
    “leaflet” in the text of the directive is preventing
    the wide-spread use of e-labelling)
  • The safeguard clause will be put in line with the
    new requirement set for such clauses by the review of
    the ‘new approach’ directives
  • Administrative co-operation will be encouraged,
    subject to a suitable legal basis and budget line
  • In line with the objective of promoting
    transparency, certain documents, such as final
    vigilance reports will be made accessible to the
  • A reference to borderline products which do not
    belong to the category of medical devices (such as
    cosmetics and personal protective equipment) will
    remain in the text. A particular concern is the
    category of ‘miracle products’ which in some Member
    States count as medical devices while in others do

Representatives of the medical device industry voiced
concerns on a number of points in the ongoing review.
Some suggested that a definition of a 'single-use device'
should be created which would clarify as to whether such
device could be used once only, or several times on the
same patient.

Some speakers representing industry said that a
clearer demarcation between pharmaceutical products and
medical devices would be necessary in view of the review
of the EU's pharmaceuticals legislation, which has
resulted in a new definition of 'pharmaceuticals'. Other
speakers complained that while in some countries one
product is considered a 'medicine', in others is treated
as a 'medical device'.

The industry representatives were reassured by the
Commission speaker that the financial impact of the new
directive on industry will also be examined in the impact
assessment exercise, to be conducted before the end of

The term 'medical device' refers to a broad range of
products, including simple bandages and spectacles,
equipment to screen health conditions, as well as small
and delicate devices, such as cardiac pacemakers.

The EU's directives covering medical devices
(90/385/EEC on Active Implantable Medical Devices and
93/42/EEC on Medical devices) are currently undergoing a

The first step in the review was a report by the
Medical Devices Expert Group in June 2002 on the
functioning of the medical devices directive. This was
followed by a Communication from the Commission in July
2003 to which the Council adopted conclusions in December
2003. A first version of the proposal for a new directive
is currently being drafted by the medical devices unit of
DG Enterprise.

The directives relating to medical devices follow the
so-called 'new approach', i.e. they only define the
essential requirements that devices have to meet when
marketed but allow flexibility regarding technological
solutions. The objective of such directives is to enable
a regulatory approach flexible enough to allow for
technological progress. The essential requirements relate
to issues such as risk assessment and risk management, as
well as chemical, physical and biological

  • The Medical Devices Expert Group will discuss a
    first draft of the directive in October 2004
  • The Commission will conduct an impact assessment of
    the new directive, in part, via the Internet
  • DG Enterprise is expected to agree a final version
    of the proposal in December 2004 which will then be
    submitted for inter-service consultation and
  • The proposal will be submitted to Council and
    Parliament in spring 2005 after approval by the

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