reg 44ZC Interpretation of Part 4A
In this Part— “ corrective action ” means action taken in order to— eliminate the cause of a potential or actual non-conformity of a device, or reduce any other risk posed by a device, that has already been manufactured and may include recalling the device, withdrawing it from the market, and taking it out of service; “ field safety corrective action ” means a corrective action taken by the manufacturer to prevent or reduce the risk of a serious incident in relation to a device which has already been placed on the market or put into service; “ incident ” means in relation to a device that has been placed on the market or put into service— a malfunction or deterioration in the characteristics or performance of the device when used in accordance with the instructions for use, a side-effect that has a negative impact on— the health of an individual, patient management, or public health, an inadequacy in the design of the device, including an ergonomic feature, to enable the user to use the device safely and as intended by the manufacturer, an inadequacy in the information supplied with the device by the manufacturer to enable the user to use the device safely and as intended by the manufacturer, or an erroneous result provided by a diagnostic medical device, which informs a decision in relation to medical treatment; “ lifetime of a device ” means the shelf life of a device (if there is one) plus the period that the manufacturer expects that device to perform as intended; “ PMS period ” means the period— beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, and ending with the end of the lifetime of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later; “ post-market surveillance ” means activities carried out by manufacturers to proactively collect and review experience gained from devices placed on the market or put into service for the purposes of identifying any need to apply corrective or preventive actions; “ preventive action ” means action taken by the manufacturer before completion of the manufacturing phase in order to eliminate the cause of a potential non-conformity or reduce a potential risk that could be posed by the finished device; “ Regulation (EU) No 722/2012 ” means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin, as it had effect in the EU on 25 May 2021; “ relevant device ” means a device that is a “ relevant device ” for the purposes of Part 2, 3 or 4; “ relevant essential requirements ” means— in relation to a device placed on the market in accordance with regulation 19B, the essential requirements set out in Annex I of Directive 93/42 and, where applicable, Regulation (EU) No 722/2012 which apply to it; in relation to a device placed on the market in accordance with regulation 19C, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745 which apply to it; in relation to a device otherwise placed on the market or put into service in accordance with Part 2, the requirements referred to in regulation 8 (essential requirements for general medical devices) which apply to it; in relation to a device placed on the market in accordance with regulation 30A, the essential requirements set out in Annex I of Directive 90/385 and, where applicable, Regulation (EU) No 722/2012 which apply to it; in relation to a device otherwise placed on the market or put into service in accordance with Part 3, the requirements referred to in regulation 22 (essential requirements for active implantable medical devices) which apply to it; in relation to a device placed on the market in accordance with regulation 44ZA, the essential requirements set out in Annex I of Directive 98/79 which apply to it; in relation to a device placed on the market in accordance with regulation 44ZB, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/746 which apply to it; in relation to a device otherwise placed on the market or put into service in accordance with Part 4, the essential requirements referred to in regulation 34 (essential requirements for in vitro diagnostic medical devices) which apply to it; “ required risk analysis ” means the analysis required to weigh the risks posed by a device against the intended performance and benefits for the purposes of confirming conformity with the relevant essential requirements; “ serious deterioration of any person’s state of health ” means any of the following— life-threatening illness or injury; permanent impairment of a body structure or a body function; hospitalisation or prolongation of hospitalisation; medical treatment, including surgical intervention and self-administered treatment, that is required to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; chronic disease; foetal distress, foetal death or a congenital physical or mental impairment or birth defect; “ serious incident ” means an incident that directly or indirectly led, might have led or might lead to any of the following— the death of any person; the serious deterioration of any person’s state of health; a serious public health threat; “ serious public health threat ” means an event which could result in a risk— of death, serious illness, or serious deterioration of any person’s state of health, that affects a significant population, and that requires prompt remedial action; “ similar device ” means a device which— has the same or a similar intended purpose, and is based on the same or similar technology; “ system or procedure pack ” has the same meaning as in regulation 5(1).