Can projects involving clinical evaluation medicines and medical devices be submitted to the competition?
It is not possible to submit proposals for projects that consist in clinical evaluation of medicines according to the provisions of Act No. 378/2007 Coll., on Medicinal Products and on the amendment of some related acts, as amended (hereinafter referred to as the Medicinal Products Act), or clinical testing of medical devices according to Act No. 268/2014 Coll., on Medical Devices and on the amendment of Act No. 375/2022 Coll, on medical devices and in vitro diagnostic medical devices, as amended (hereinafter referred to as the Medical Devices Act) and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ("MDR") which are not approved or duly notified/registered or which would require substantial changes/alteration of the registration including a variation procedure (i.e. change of the medicinal substance, form of administration, strength, pack size, use of an approved medical device other than as declared by the manufacturer, etc.), except for clinical evaluation / trials conducted by non-commercial sponsors. The sponsor of the clinical evaluation/ trial must be the applicant/co-applicant. The health service provider does not have to be the sponsor of the clinical evaluation/clinical trial, but must always be the applicant/co-applicant (or future beneficiary/co-beneficiary).
