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Update from DITTA
11.20.13 DITTA Statements
DITTA welcomes the progress made towards medical device regulatory harmonization at the 4th meeting 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The IMDRF Management Committee reviewed the six Work Items during its meetings on 12 and 14 November, including draft guidance documents previously put in for public consultation.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.
11.19.13 DITTA Statements
BRUSSELS – 19 November 2013 – On 14 November, DITTA organised the event ‘Regulating Medical Software: What to expect in the coming year’. It was attended by global representatives from academia, industry and policymakers, including regulators involved in the International Medical Device Regulation Forum (IMDRF).
Taking place in the offices of the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), the event saw presentations on EU and US regulatory updates, industry perspectives on regulation and related challenges, international software standards, software security and how to ensure good software deployment.
Breakout sessions brought the audience together to discuss barriers and needs regarding medical software legislation. Lack of global harmonisation was one of the main issues identified. IMDRF Working Group Chair Bakul Patel, from US FDA, shared the progress made since its inception in May 2013 towards a global harmonised regulatory framework on software as a medical device.
Nicole Denjoy, DITTA Chair, urged regulators to move towards harmonisation, “Policymakers need to take advantage of existing standards and keep up with the fast pace of societal, technical, regulatory and legal changes. There is a need to involve key stakeholders and new players in decision-making and to build awareness of the issues surrounding medical software.”
The agenda of the event and all the presentations are available on the event website.
+32 496 116 198
10.28.13 DITTA Statements
BRUSSELS – 28 October 2013 – DITTA today announces that ITAC, the Information Technology Association of Canada, has joined the global association.
ITAC is the national association of Canada’s information and communications technology (ICT) industry, representing a broad range of large, medium and small enterprises spanning telecommunications and internet services, ICT consulting services, hardware, microelectronics, software and electronic content. ITAC’s mission is to promote and enhance the significant contribution that digital technology can make to Canada’s economic prosperity.
Brendan Seaton, President of ITAC Health, said, “We have decided to join DITTA to benefit from its global activities, in particular from the exchange of best practice and expertise with other stakeholders and the opportunities to collaborate with the other DITTA members on removal of trade barriers, as we aim to expand the market reach of our members”.
Nicole Denjoy, DITTA Chair, added, “We are delighted to have ITAC on board, as we share the same commitment to the promotion of sensible regulation, harmonized regulatory frameworks and the use of international standards to further develop our industries and improve access to the life-saving products our members manufacture around the globe. The addition of ITAC will further amplify our global voice, and enhance DITTA’s capacity to respond to challenges and promote the interests of our industry worldwide”.
For more information, contact
Tel: +32 (0)2 706 8961
President, ITAC Health
DITTA Communications Advisor
Tel: +32 (0)496 116198
Note to the Editor
ITAC is the voice of the Canadian information and communications technologies (ICT) industry which is comprised of about 33,300 companies, generates $155 billion in revenues, contributes $67.2 billion to the Canadian GDP, accounts for 3% of total employment (approximately 572,700 jobs) and is the largest performer of private sector R&D ($4.8 billion).