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IAPO highlights patient perspective on international regulatory convergence
by IAPO at 3:39PM Wednesday 03 April 2013 (News)

Jo Groves, IAPO CEO, presented some reflections on current initiatives to develop regulatory systems for medical devices. She made the comments at the International Medical Device Regulators Forum's stakeholder meeting which took place on Wednesday 20 March 2013. The Forum, held in Nice, France, brought together regulators from around the world with a broad range of other stakeholders including the World Health Organization (WHO). The Forum works to accelerate international medical device regulatory convergence in order to support timely access to safe and effective medical devices globally.

Jo's presentation focused on the key patient-centred principles that should inform approaches to the development of the regulation of medical devices as outlined in IAPO's Declaration on Patient-Centred Healthcare; namely those of respect, choice and empowerment, patient involvement in health policy, access and support, and information. The presentation highlighted key questions that the regulatory process should consider such as, 'In the patient's opinion does the technology improve or maintain quality of life?' and, 'Are the risks of side effects of harm acceptable in the patient's view given the benefits?'. Jo concluded that, above all, patient involvement is necessary in all aspects from device development through to regulatory processes in order to improve access to safe, effective and appropriate medical devices.

The panel session included presentations from WHO, regulatory, healthcare professional and industry representatives and was followed by a discussion where the importance of stakeholder engagement and communication was highlighted.

To read more about IMDRF, please click here.

To view the slides from Jo's presentation, please click here.

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