The European Union is currently reviewing the regulatory framework for medical devices to establish new clinical evidence and standards and to align the rules with the new Clinical Trials Regulation for Medicinal Products and we presented the asthma, allergy and COPD patients’ expectations on this revision.
The clinical development of medical devices is a process spanning the full product lifecycle, and patient input is crucial all along the way. That is why EFA was invited to the EFGCP-MedTech Europe workshop on Ethics, Quality and Oversight in the Clinical Development of Medical Devices on the 15th of June, where EFA EU Policy and Membership Officer Jelena Malinina was a panelist.
During the conference we explored existing best practices and forthcoming changes in the clinical development of medical devices. Jelena presented what patients expect from the upcoming regulation and clinical investigations on medical devices and took the opportunity to call for greater transparency, safety and patients’ involvement in the development of medical devices addressed to the use of asthma, allergy and COPD patients.
For more information, EFA’s full presentation is available here.