The Academy and other stakeholders are engaged with on going discussion around European legislation regarding medical devices and in vitro diagnostics, and amendments associated with the proposed regulation.Status: Completed
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In January 2013, the Academy responded to the Medicine and Healthcare product Regulatory Agency (MHRA) public consultation on the revision of European legislation on medical devices and in vitro diagnostics.
The response was a joint submission with the Royal Academy of Engineering. It was informed by consultation with Fellows of both Academies and with external stakeholders, and by two events undertaken by the Academies:
- Royal Academy of Engineering and Academy of Medical Sciences roundtable titled: How can high-level evidence be established for the safety and efficacy of medical devices. The meeting brought together regulators, and clinicians and engineers from academia and industry, to discuss current challenges and explore future options for generating safety and efficacy/effectiveness data for medical devices.
- The Academy of Medical Sciences symposium on stratified medicine. The meeting brought together experts from the pharmaceutical and diagnostic industries, health economists, medicines regulators, health service providers, clinical researchers and policy makers with the aim to progress stratified medicines research and development, and the implementation of these approaches in healthcare services. Regulation of companion diagnostics and ‘in-house’ in vitro diagnostics was one of the key topics of discussion at this meeting.
The Academy continues to engage with the MHRA as negotiations regarding revision of this legislation continue at European level.
In April 2015, the Academy signed a joint statement relating to proposed EU In Vitro Diagnostic Medical Devices Regulation 2012/0267(COD) and amendments on its genetic testing provision.
The statement broadly supports the Commission’s proposals to provide a regulatory framework for this area, but notes significant concerns with the amendments adopted by the European Parliament, which could have a damaging effect on the provision of genetic tests for patient benefit and potentially limit the uptake of new healthcare innovations. It particularly highlights amendment 271 which, if adopted, risks restricting access to genetic testing by establishing very specific requirements for the use of such tests.
Overall, the statement calls for regulation in this area to be both flexible and proportionate, to ensure the development of high quality products, while encouraging appropriate information provision for their use.
Further information is available from either the Wellcome Trust or PHG Foundation. Other organisations which have signed the statement include Cancer Research UK, the British Heart Foundation, Arthritis Research UK and a large number of other organisations from across the research and higher education sector.