Guide To Placing Medical Device Standalone Software on the Market SUR-G0040-2 21 AUGUST 2020 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. HPRA Guide to Placing Medical Device Standalone Software on the Market _______________________________________________________________________________________________________________________ CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 DEFINITIONS 4 4 GENERAL OVERVIEW OF PROCEDURE FOR AFFIXING A CE MARK 7 5 HPRA VIGILANCE AND MARKET SURVEILLANCE 17 6 WHO TO CONTACT AT THE HPRA 18 SUR-G0040-2 2/18 HPRA Guide to Placing Medical Device Standalone Software on the Market _______________________________________________________________________________________________________________________ 1 SCOPE This document applies to standalone software that falls within the definition of a medical device under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, and related amendments that was transposed into Irish law by: S.I. No. 252 of 1994 European Communities (Medical Devices) Regulations, 1994 that became mandatory on 14 June 1998 (amended by S.I. No. 444 of 2001, S.I. No. 576 of 2002 and S.I. No. 110 of 2009), which will hereafter be called S.I. No. 252 of 1994. This document also applies to standalone software that qualifies as an in vitro diagnostic medical device (IVD) or as an accessory to an IVD in accordance with the Council Directive 98/79/EEC concerning IVD and related amendments that was transposed into Irish law by: S.I. No. 304 of 2001 European Communities (In Vitro Diagnostic Medical Devices) Regulations, 2001 that became mandatory on 14 June 1998 (amended by S.I. No. 576 of 2002 and S.I. No. 207 of 2012), which will hereafter be called S.I 304 of 2001. This document also applies to standalone software that qualifies as an active implantable medical device (AIMD) in accordance with the Council Directive 90/385/EEC concerning active implantable medical devices and related amendments that was transposed into Irish law by: S.I. No. 254 of 1994 European Communities (Active Implantable Medical Devices) Regulations, 1994 that became mandatory on 14 June 1998 (amended by S.I. No 110 of 2009), which will hereafter be called S.I. No. 253 of 1994. In this guide, the term ’Regulations’ is a reference to S.I. No. 252 of 1994, S.I. No. 304 of 2001 and S.I. No 253 of 1994. Software incorporated into a medical device is outside the scope of this document. 2 INTRODUCTION Standalone software plays an important role in the delivery of healthcare within healthcare institutions. For example, it may be used to control or monitor the performance of medical devices remotely, for patient management activities, or as an aid for treatment planning. Standalone software, along with any associated mobile technology, is an integral part of eHealth, the integration of information and communication technology with delivery of healthcare. Advances in mobile technology in recent years, such as smart phones and tablets, have seen a large increase in the use of standalone software both within healthcare facilities and in patients’ homes. Mobile devices allow users quick and easy access to the functionality provided by different ‘mobile applications’ (apps). SUR-G0040-2 3/18 HPRA Guide to Placing Medical Device Standalone Software on the Market _______________________________________________________________________________________________________________________ Standalone software may be considered a medical device in its own right when it is intended for a medical purpose that meets the definition of a medical device, as defined in S.I. No. 252 of 1994 and elaborated in section 4 of this document. Depending on the specific intended purpose, standalone software may qualify as an IVD medical device or an AIMD, in which case S.I. No. 304 of 2001 or S.I. No 253 of 1994 apply respectively. Not all standalone software used in the healthcare sector are medical devices. For example, apps for general health and wellbeing that record lifestyle habits such as smoking and exercise are generally not considered as medical devices. It is essential that manufacturers of standalone software understand whether their product is a medical device or not. Only medical devices that are compliant with the relevant legislation can be placed on the Irish and European market. The purpose of this document is to provide a general overview of the regulatory process involved in placing a medical device on the market for manufacturers and to provide additional guidance that is specifically relevant to standalone software. 3 DEFINITIONS 3.1 Medical device A ‘medical device’ is defined in S.I. No. 252 of 1994 as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. The definition of a medical device in S.I. No. 253 of 1994 differs slightly from the above definition as referred to in 4.3 below. 3.2 In vitro diagnostic medical device ‘In vitro diagnostic medical device’ (IVD) means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the SUR-G0040-2 4/18 HPRA Guide to Placing Medical Device Standalone Software on the Market _______________________________________________________________________________________________________________________ examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: - concerning a physiological or pathological state, or - concerning a congenital abnormality, or - to determine the safety and compatibility with potential recipients, or - to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination. 3.3 Active implantable medical device ‘Active implantable medical device’ (AIMD) means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. The definition of a medical device in S.I. No. 253 of 1994 is such that an accessory to an AIMD (e.g. accessory software) intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for the proper application of the AIMD should be treated as an AIMD. Refer to MEDDEV 2.1/2 for more information. For example, standalone software that is intended to be used as an accessory to an AIMD (e.g. to communicate programming information with an implantable cardiac defibrillator) is treated as an AIMD and the manufacturer must follow the appropriate conformity assessment process (section 4.2) for an AIMD. 3.4 Accessory S.I. No. 252 of 1994 and S.I. No. 304 of 2001 define an ‘accessory’ as an article which whilst not being a medical device or an IVD is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device as intended by the manufacturer of the device. 3.5 Standalone software For the purpose of this guidance, ‘standalone software’ means software which is not incorporated into a medical device at the time of its placing on the market or its making available. SUR-G0040-2 5/18 HPRA Guide to Placing Medical Device Standalone Software on the Market _______________________________________________________________________________________________________________________ 3.6 Medical device standalone software The term ’medical device standalone software’ is used in this document as a general term that refers to standalone software (defined in section 3.5) that meets the definition of a medical device, IVD or an AIMD without being part of a hardware medical device. ’Without being part of’ means software not necessary for a hardware medical device to achieve its intended medical purpose1. 3.7 Intended purpose The use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials. 3.8 Manufacturer A ‘manufacturer’ of a medical device, as defined in the legislation, means the natural or legal