Medicinal products and medical devices
Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018) 51 final) (49 page(s), in English; 49 page(s), in French; 49 page(s), in Spanish)
This proposed Regulation concerns harmonised rules for carrying out the clinical assessment part of health technology assessment in EU Member States and introduces a system of joint assessments carried out at Union level for certain medicinal products and medical devices.