MEDICAL DEVICE AND IN VITRO DIAGNOSTIC DEVICE MARKET WITHDRAWAL AND RECALL GUIDANCE

CHAPTER I

Preamble, Scope, Grounds and Definitions

Preamble

ARTICLE 1- (1) This Guidance intends to describe and lay down the procedures and rules applicable to:

1. Market withdrawals and recalls of medical devices and in vitro diagnostic devices, and
2. The duty and reference frames, roles and responsibilities of the Agency, economic operators and other public agencies and organisations to this end.

Scope

ARTICLE 2- (1) This Guidance applies to devices already or prospectively placed or made available on the market or put into service physically or by distance communication means under the Regulation on Medical Devices and the In Vitro Diagnostic Device Regulation, both enacted on publication in the Official Journal of Legislative Acts Release 31499 of 2 June 2021.

Grounds

ARTICLE 3- (1) This Guidance has been prepared on grounds of Section 16 of the Product Safety and Technical Requirements Act 7223 of 5 March 2020, Articles 506, 508 and 796 of the Presidential Decree 4 on the Organisation of Ministerial Divisions, Affiliates and Subsidiaries enacted on publication in the OJLA Release 30497 of 15 July 2018, and Article 16 of the Framework Regulation on Market Surveillance of Products as published in the OJLA Release 31537 of 10 July 2021.

Definitions

ARTICLE 4- (1) As used in the context of this Guidance,

1. Significant risk device: Means a device presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the device, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by designated bodies, including cases where the effects of the risk are not immediate,
2. Device: Means any medical device, in vitro diagnostic device or accessory thereof as covered by the Regulation on Medical Devices and In Vitro Diagnostic Device Regulation published on the OJLA Release 31499 (Bis) of 2 June 2021.
3. Distributor: Means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market,

ç) Corrective action: Means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation,

1. Recall: Means any measure aimed at achieving the return of a device that is already held in possession of an end user back to the economic operator,
2. Safe device: Means any device which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the device’s use,