DITTA welcomes the progress made towards medical device regulatory harmonization at the 4thmeeting of the International Medical Device Regulators Forum (IMDRF), chaired by the European Commission in Brussels, Belgium, on 12-14 November, 2013, under the leadership of Despina Spanou.

The IMDRF Management Committee reviewed the six Work Items during its meetings on 12 and 14 November, including draft guidance documents previously put in for public consultation.  Several of these guidance documents have now been adopted and will be posted on the IMDRF website in the coming weeks.  DITTA applauds all IMDRF members for these achievements, which will provide a basis for further regulatory convergence between the IMDRF jurisdictions.

DITTA engaged with IMDRF as an active partner throughout IMDRF.  DITTA members participated in the Open Stakeholder Forum event on 13 November, which included an interactive afternoon session with stakeholder presentations on the theme “Innovation for Safety.”  Nicole Denjoy, DITTA Chair and COCIR Secretary General, speaking at this stakeholder session, presented DITTA’s position on the challenges and opportunities facing the industry in this area, and drew the audience’s attention to the many opportunities for improved patient safety and economic growth offered by the prospect of international regulatory convergence for medical devices.

The 2014 IMDRF meetings will be hosted by the United States under the leadership of the Food and Drug Administration, starting with IMDRF-5 in San Francisco, USA, on 25-27 March, 2014.