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

Want to know what's going on in the EU Capitals daily? Subscribe now to our new 9am newsletter.