MEPs urge Member States to make sure single-use medical devices are not re-used

On 3 June, the European Parliament adopted an own-initiative report on the health implications of the medical devices directive.

The report by
Minerva Melpomeni MALLIORI (PES, GR),
adopted by MEPs without amendment, states that

  • a distinction should be made between medical devices having a
    pharmacological effect (which were subject to another directive
    drawn up in 2001) and those which do not;
  • clinical data needs to be available and relevant for the
    medical device in question;
  • the Commission should explain in writing whether soft PVC
    medical devices comply with the essential requirements laid down in
    the 1993 directive;
  • post-market surveillance must be improved so as to reflect the
    risks involved with the device and recommends that a system be put
    into place for tracking high risk devices;
  • there is a need for informative labelling and leaflets
    containing instructions for use, describing any possible
    side-effects of the devices;
  • the Member States should ensure that single-use devices are not
    re-used, given the risk which such re-use pose for patients and
    hospital staff (see also
    EURACTIV 22 March
    2003
    ).

 

Subscribe to our newsletters

Subscribe
Contribute