Medical Devices Ordinance (MedDO) (MedDO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 30 Establishment licence
1 An establishment licence issued by Swissmedic is required for any natural or legal person who: a. removes tissues or cells from humans for the purpose of devitalising the tissues or cells and using them to manufacture devices or supplying them for use in device manufacture; b. stores tissues or cells collected for the purposes in letter a; c. imports or exports tissues or cells collected for the purposes in letter a. 2 A licence shall be issued if: a. the requirements in terms of professional qualifications and operational infrastructure are fulfilled; b. a quality assurance system that complies with current scientific and technological standards is in place; c. the facility has a Responsible Person with the necessary specialized knowledge, experience and directive authority in their area of activity and who is responsible for quality; d. the obligations specified in Articles 31 and 32 are fulfilled. 3 Swissmedic shall verify that the conditions for issuing an establishment licence a
Para. 4 — SR 812.212.1
Art. 31 Collection, donation and testing
1 The requirements of Articles 3, 4, 6–15 and 30–33 of the Transplantation Act of 8 October 2004 and of Articles 2–12 of the Transplantation Ordinance of 16 March 2007 apply mutatis mutandis to collection, donation and testing. 2 Holders of an establishment licence issued under Article 30 must verify the suitability of donors.
Para. 1 — SR 810.21 Para. 1 — SR 810.211
Art. 32 Duty to keep records and traceability
1 It must be possible to trace all tissues and cells collected from humans for the purpose of devitalisation and use in devices from the donor to the recipient and vice versa. Article 35, paragraphs 1 and 2, MPLO also apply mutatis mutandis. 2 Moreover, the provisions of Articles 34 and 35 of the Transplantation Act of 8 October 2004 apply mutatis mutandis to traceability.
Para. 1 — SR 812.212.1 Para. 2 — SR 810.21
