Bulgarian Institute for Standardization
Standards – always a step ahead
Phone: +359 2 8174 523, +359 2 8174 504
E-mail: info@bds-bg.org
1797 Sofia, 13 "Lachezar Stanchev" Str., "Izgrev" Complex
ID number: 175079183, VAT number: BG175079183
Main menu

prБДС EN IEC 62304:2021

Health software - Software life cycle processes

General information

40.60     Mar 26, 2021

45.99    Jan 4, 2019



European Standard

11.040     11.040.01  

Appropriate for SMEs


1.1 * Purpose
This document defines the development and maintenance life cycle requirements for HEALTH SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for HEALTH SOFTWARE life cycle PROCESSES.
1.2 * Field of application
This document applies to the development and maintenance of HEALTH SOFTWARE by a MANUFACTURER. MEDICAL DEVICE SOFTWARE is a subset of HEALTH SOFTWARE (see Figure 2).
Therefore, this document applies to:
- software as part of a MEDICAL DEVICE;
- software as part of specific health hardware;
- software as a MEDICAL DEVICE (SaMD);
- software-only product for other health use.
Figure 2 provides a graphical representation of the health software this document applies to.
[Figure 2]
NOTE 1 Examples of HEALTH SOFTWARE include the following:
1) software as a part of a MEDICAL DEVICE: software that is an integral part of a device such as an infusion pump or dialysis machine.
2) software as part of specific health hardware: patient wristband printer software, healthcare scanner software, health app on specific wearable hardware (i.e. watch, wristband, chestband).
3) software as a MEDICAL DEVICE (SaMD): software that is itself a MEDICAL DEVICE, such as a software application that performs diagnostic image analysis for making treatment decisions. A definition of software as a MEDICAL DEVICE is provided in [46] 1.
4) software-only product for other health use: hospital information systems, electronic health records, electronic medical records, mobile applications running on devices without physiologic sensors or detectors, software as a service, i.e. software executed in an external environment, providing calculation-results that fulfil the definition of a MEDICAL DEVICE.
NOTE 2 This document can be used in the development and maintenance of HEALTH SOFTWARE. Before any type of software can be placed into service, activities are necessary before the software product is integrated into the SYSTEM. These SYSTEM activities are not covered by this document (see Figure 1), but can be found in related product standards (e.g., IEC 60601-1 [1] or IEC 82304-1 [15]). For software as a MEDICAL DEVICE (SaMD) additional guidance on ACTIVITIES at a system level (e.g. clinical EVALUATION) can be found in regulatory authority guidance documents.

Directives and Regulations

When the standard is harmonized under a directive or regulation, the word Harmonized appear. When such an inscription does not appear, it means that the standard is related to / supporting the relevant directive or regulation.


Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC


Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Life cycle


prБДС EN IEC 62304:2021
40.60 Close of voting
Mar 26, 2021

Related project

Adopted from prEN IEC 62304:2021

Adopted from IEC 62304 ED2