CHAPTER IV

PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES AND CELLS

Responsible person
Article 17
1
Every tissue establishment shall designate a responsible person who shall at least fulfil the following conditions and have the following qualifications:
a
possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned;
b
at least two years' practical experience in the relevant fields.
2
The person designated in paragraph 1 shall be responsible for:
a
ensuring that human tissues and cells intended for human applications in the establishment for which that person is responsible are procured, tested, processed, stored and distributed in accordance with this Directive and with the laws in force in the Member State;
b
providing information to the competent authority or authorities as required in Article 6;
c
implementing the requirements of Articles 7, 10, 11, 15, 16 and 18 to 24 within the tissue establishment.
3
Tissue establishments shall inform the competent authority or authorities of the name of the responsible person referred to in paragraph 1. Where the responsible person is permanently or temporarily replaced, the tissue establishment shall immediately inform the competent authority of the name of the new responsible person and the date on which the duties of that person commence.