INSTRUCTIONS OF USE OF MEDICAL DEVICES

PART I

Preliminary Provisions

Preamble

ARTICLE 1- (1) This Circular aims to establish conditions under which instructions for use of medical devices referred to in point (ıı), first paragraph of Article 3 of the Turkish Medical Device Regulation as published on the OJLA Release 31499 bis of 2 June 2021 and detailed further under paragraph 23.4, Part III of Annex I thereto can be provided in electronic form instead of in paper form in the manner referred to in point (e), Article 23(1), Part III of the same Annex to the Regulation and to specify certain requirements relating to the contents of instructions for use provided by manufacturers in electronic form in addition to instructions for use supplied with deliveries of their medical device products in paper form as well as for web sites reserved for or dedicated to their public disclosure and views, on-line.

Scope

ARTICLE 2- (1) This Circular covers and affects all processes and procedures that manufacturers of medical devices referred to in Article 5 and the Agency will perform in their respective roles of providers and the facilitator of such information as defined.

(2) This Circular does not cover or affect products listed in Annex XVI to the Medical Device Regulation.

Grounds

ARTICLE 3- (1) This Circular draws its issue and effect from the Product Safety and Technical Regulations Act No. 7223 of 3-5-2020, Articles 508 and 796 of the Presidential Decree No. 4 Governing the Establishment, Powers and Duties of Ministerial Bodies, Related Entities and Organisations and Other Institutions and Establishments In Affiliation Therewith, and the Medical Device Regulation.

Definitions

ARTICLE 4- (1) As used in the context, and for the purpose of this Circular;

1. Instructions for use in electronic form: Means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through a software or a website,