Module 16 2022

9/2/2022

Important Definitions – Special Considerations for SaMD and Apps Software Software is today essential for the functioning of products. Under the medical device and in vitro medical devices legislation, software in its own right presenting certain features is considered as a medical device or an in vitro diagnostic medical device (41). Certain pieces of Union harmonisation legislation refer explicitly to the software integrated in the product (42). Software updates or repairs could be assimilated to maintenance operations provided that they do not modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected . As is the case for physical repairs or modifications, a product should be considered as substantially modified by a software change where: i) the software update modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) iii) the product is made available (or put into service where this is covered by the specific Union harmonisation legislation).

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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Important Definitions – Legacy vs. Old Devices What are Legacy Devices?

The missing definition is provided by the guidance document MDCG 2021-25 ( Regulation (EU) 2017/745 – application of MDR requirements to 'legacy devices' and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/ EEC or 93/42/EEC ): Legacy devices are devices placed on the market according to Article 120(3) of the MDR after the application date of the MDR and under certain conditions until May 26, 2024.  (1) Class I devices according to Directive 93/42/EEC (MDD) for which a declaration of conformity was issued before May 26, 2021 and for which the conformity assessment procedure according to the MDR requires the involvement of a notified body;  (2) Medical Devices having a valid EC certificate issued before May 26, 2021 in accordance with Directive 90/385/EEC (AIMDD) or the MDD. The terminology of ‘legacy devices’ and ‘old devices’ is in line with existing MDCG guidance such as MDCG-2021-13 rev.1

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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