MEDICAL DEVICES REGULATION

PART ONE

Purpose, Scope, Basis, Definitions and Regulatory Status of Products

CHAPTER ONE

Purpose, Scope, Basis and Definitions

Purpose and Scope

ARTICLE 1 - (1) The purpose of this Regulation is to determine the procedures and principles regarding the placing on the market, keeping on the market or making available for service medical devices and their accessories intended for human use, by establishing high quality and safety standards for medical devices, based on the principle of high-level protection of health for patients, users and other persons. This Regulation also applies to clinical trials conducted on medical devices and their accessories, aiming to ensure that the data obtained from clinical trials are reliable and robust and to protect the safety of volunteers participating in clinical trials.

(2) For the purposes of this Regulation, medical devices, medical device accessories and the products listed in Annex XVI to which this Regulation applies shall hereinafter be referred to as “devices”.

(3) This Regulation applies to:

a) all medical devices except in vitro diagnostic devices;

b) non-medical product groups listed in Annex XVI and clinical trials related to these product groups, taking into account the harmonized standards available and the latest technological developments, in particular for similar medical devices based on similar technology, from the date of application of the common specifications adopted pursuant to Article 9;

c) devices manufactured using non-living or rendered non-living animal-derived tissues or cells or their derivatives;

d) devices manufactured using non-living or rendered non-living human-derived tissues or cell derivatives.

(4) This Regulation applies to:

a) In vitro diagnostic devices included within the scope of the Regulation on In Vitro Diagnostic Medical Devices published in the Official Gazette dated 2/6/2021 and numbered 31499 (repeated issue),

b) (Amended: RG-29/7/2022-31907) Medical products as defined in subparagraph (b) of the first paragraph of Article 4 of the Regulation on Licensing of Human Medicinal Products published in the Official Gazette dated 11/12/2021 and numbered 31686,

c) (Amended: RG-29/7/2022-31907) Advanced therapy medicinal products, including gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineering medicinal products,

d) Human blood, blood products, human-derived plasma or blood cells, or, excluding the devices referred to in the sixth paragraph, products containing such blood products, plasma or cells when placed on the market or put into service. devices,

d) products within the scope of the Cosmetics Regulation published in the Official Gazette dated 23/5/2005 and numbered 25823,

e) animal-derived transplants, tissues or cells or their derivatives, or products containing or consisting of them, excluding devices manufactured using inanimate or rendered inanimate animal-derived tissues or cells or their derivatives,

f) human-derived transplants, tissues or cells or their derivatives, or products containing or consisting of them, within the scope of the Regulation on Quality and Safety of Human Tissues and Cells and Related Centers dated 27/10/2010 and numbered 27742, excluding devices manufactured using derivatives of inanimate or rendered inanimate human-derived tissues or cells,

g) unlike the products referred to in clauses (c), (e) and (f), living microorganisms, including bacteria, fungi or viruses, used to achieve or support the intended use of the product. products containing or consisting of biological material or living organisms,

g) foods covered by the Veterinary Services, Plant Health, Food and Feed Law No. 5996 dated 11/6/2010,

does not apply.