assessment scopemeans the set of parameters for joint clinical assessment in terms of patient population, intervention, comparators and health outcomes requested jointly by Member States.
collaborative assessmentmeans a clinical assessment of a medical device or an in vitro diagnostic medical device carried out at Union level by a number of interested HTA authorities and bodies participating on a voluntary basis;
health technologymeans a health technology as defined in Article 3, point (l), of Directive 2011/24/EU;
HTAmeans a multidisciplinary process that summarises information about the medical, patient and social aspects and the economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner;
in vitro diagnostic medical devicemeans an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746;
medical devicemeans a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745;
medicinal productmeans a medicinal product as defined in Article 1, point (2), of Directive 2001/83/EC of the European Parliament and of the Council;
non-clinical assessmentmeans the part of an HTA based on the non-clinical domains of HTA of the cost and economic evaluation of a health technology, and the ethical, organisational, social and legal aspects related to its use;