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Definitions For the purposes of this Regulation, the following definitions apply:

(1) ‘medicinal product’ means a medicinal product as defined in Article 1, point (2), of Directive 2001/83/EC of the European Parliament and of the Council ;

(2) ‘medical device’ means a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745;

(3) ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746;

(4) ‘health technology’ means a health technology as defined in Article 3, point (l), of Directive 2011/24/EU;

(5) ‘health technology assessment’ or ‘HTA’ means 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;

(6) ‘joint clinical assessment’ of a health technology means the scientific compilation and the description of a comparative analysis of the available clinical evidence on a health technology in comparison with one or more other health technologies or existing procedures, in accordance with an assessment scope agreed pursuant to this Regulation, and based on the scientific aspects of the clinical domains of HTA of the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;

(7) ‘non-clinical assessment’ means 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;

(8) ‘collaborative assessment’ means 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;

(9) ‘assessment scope’ means the set of parameters for joint clinical assessment in terms of patient population, intervention, comparators and health outcomes requested jointly by Member States.