2014 GA Agenda item 9.5 medical device regulation

Related to GA 2014 Agenda item 9.5.

Since the last GA….

At the 2013 GA EAHP passed policy on the issue of medical device regulation in order to signal and profile to policy makers the role of hospital pharmacists in Europe in the use of medical devices in the hospital sector and to give the EAHP mandate to participate in the debate on the topic.

The subsequent discussions within the European Parliament about the correct reforms to be made to medical device regulation have been lengthy and divisive, especially on the point about whether high risk medical devices should be subject to centralised authorisation by the European Medicines Agency in the same way that medicines are, and similar to the approach taken in the United States.

In the end, the Parliament has adopted a compromise suggestion of heightened oversight of the current devolved arrangements whereby national level 'notified bodies' can give pan-European 'CE' approval to devices.

As the Parliament and European Commission came to the end of their terms in April 2014, the Commission's proposed new Regulation remains unresolved, with the new European Parliament being required to resume its negotiations with the Commission and the Council of Ministers (national health ministries).

The debate will continue in the year ahead and EAHP will continue to monitor, advise members and respond appropriately to developments.

 

EAHP policy and statement here.

 

Further documents of a background nature may be added to this page in the weeks proceeding the General Assembly.