You are advising a Member of Parliament (MP) who is preparing for a debate on medical device regulation as a result of the recent vaginal mesh scandal. The MP has drawn your attention to an editorial in The Guardian newspaper on 17 August 2017 that states as follows: [t]he approval process for medical devices is poorly regulated in comparison to drugs: no large-scale, randomised controlled trials are required, and products can be introduced to the market rapidly while complications may emerge only months or years later. It is time to consider a tighter regime. In the meantime, requiring long-term follow up studies to identify problems down the line could save patients suffering, without in any way holding back innovation. The full text can be found here. The MP has asked you to draft a policy brief in order to help her to critically assess these claims in relation to medical device regulation. She seeks to understand the adequacy of the reforms under the Medical Devices Act 2021, and whether she should advocate further reforms under sections 15 and 16, and in particular s15(3)(c) of that Act.
