The European Commission (EC) has published their Proposal for a Regulation on Health Technology Assessment (HTA) on 31st January 2018. Differences between the medicinal product and medical device sectors are highlighted in the proposal. The proposal is predominately based on the Inception Impact Assessment for an EU initiative for strengthening EU cooperation on HTA published late 2016.
With the exception of generics and well-established used applications, joint clinical assessments are limited to centrally-authorised medicinal products or existing products.
Under the new proposal, the coordination group shall carry out joint clinical assessments for drugs in addition to certain medical devices classified as class IIb and III as well as in vitro diagnostic medical devices classified as class D.