SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Clinical investigations with MD on minors are possible under special provisions.
Clinical trials on minors include trials on: preterm newborns, full-term newborns (0-27 days), infants and small children (28 days-23 months), children (24 months-11 years) and teenagers (12-18 years).
A specific regulation issued by the Minister of Health covers in detail the provisions for the conduct of clinical trials on minors: Order of the Minister of Health 30 April 2004 (Dz.U. 2004 nr 104 poz. 1108)
Art 40 (10) Medical Device Act 2010 (en)
Order of the Minister of Health 30 April 2004 (Dz.U. 2004 nr 104 poz. 1108)
Yes
Special provisions apply
Art 40 (11-13) Medical Device Act 2010 (en)
Art 26 (2&3) of Act of 5 December 1996 on the professions of a physician and a dentist
Yes
Special provisions apply
Yes
Special provisions apply
Art 26(1&2) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz. 152)
Not explicitly mentioned in Medical Device Act 2010.