Medical Software Event Emphasises Need For Global Regulatory Harmonisation

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.


Kathryn Sheridan
+32 496 116 198