ESTABLISHING THE COMMON SPECIFICATIONS FOR THE GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE LISTED IN MDR ANNEX XIV

GUIDANCE

PART I

Preamble, Scope, Grounds, Definitions

Preamble

ARTICLE 1- (1) This Guidance intends to set the common specifications for those groups of products without an intended medical purpose which are listed in Annex XVI of the Medical Device Regulation, as published on OJLA Issue 31499-bis of 6-2-2021.

Scope

ARTICLE 2- (1) This Guidance applies to all groups of products without an intended medical purpose as listed in Annex XVI to the Medical Device Regulation.

(2) The common specifications included in this Guidance address the requirements laid down at points 2 through 5, 8 and 9, as well the second indent of Article 1 of Annex I to the Medical Device Regulation.

Grounds

ARTICLE 3- (1) This Guidance draws its issue and effect from the Product Safety and Technical Regulations Act 7223 of 3-5-2020, Articles 508 and 796 of the Presidential Decree No. 4 of 7-15-2018 Governing the Establishment, Powers and Duties of Ministerial Bodies, Related Entities and Organisations and Other Institutions and Establishments In Affiliation Therewith, and in particular, Article 9 of the Medical Device Regulation as published on OJLA Issue 31499-bis of 6-2-2021.