IEC 62304 is a European harmonized* standard for “medical device software.” It is entitled “Medical device software – Software life-cycle processes” and sets minimum requirements for processes such as the development and maintenance of software.
Content
On this page, you will find:
* IEC 62304 was harmonized under the MDD and IVDD and is meanwhile harmonized under the MDR and IVDR.
IEC 62304 is applicable for
Because IEC 82304-1 references the standard, IEC 62304 is even relevant for health software.
Qualification and classification
Please also note the articles on life-cycle activities under point 2.
Particular requirements for software
The following articles are grouped according to the chapters of IEC 62304.
Chapter 5.1: Design and development planning
The first requirement of the standard is to create a design and development plan. These articles are worth reading in this context:
Chapter 5.2: Requirements
The manufacturer must derive the software requirements from the requirements of the device or the stakeholder requirements.
Chapters 5.3 and 5.4: Architecture
In the architecture, the manufacturer determines the “blueprint.”
Chapters 5.5 to 5.7: Implementation and verification
The software must then be implemented and verified in accordance with the architecture. Validation is not covered by IEC 62304 but by IEC 82304-1.
Chapter 5.8: Release
Development and maintenance conclude with the release, which should not be confused with the product release:
Further requirements and processes of the standard
Medical devices that are and contain software and that have external interfaces such as USB or ethernet as subject to IT security requirements. Please note the requlatory requirements related to IT security.
In Annex I, the MDR and IVDR medical device regulations formulate the so-called “General Safety and Performance Requirements” (GSPR).
One of these requirements is that “For devices that incorporate software or for software that are devices in themselves,” the
“software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.”
This is a statutory requirement. A breach of this can be punished with fines and imprisonment as defined in national laws such as the German MDCG.
Manufacturers of medical devices should demonstrate conformity with these requirements by complying with harmonized standards.
The IEC 62304 standard is the standard specifically harmonized for life-cycle processes. Another standard is IEC 82304-1.
The FDA recognizes IEC 62304 as a “Consensus Standard,” but it does not expect conformity with this standard. However, the authority does have comparable requirements in its guidelines on software validation, for example.
Some test centers offer “certification according to IEC 62304”. Manufacturers should be aware of the limitations of these certifications:
The Johner Institute does not generally advise against certification in accordance with IEC 62304. But everyone should be aware of the “probative value” of these certificates.
Benefit from the support of the Johner Institute:
Contact us right away so that we can discuss the next steps together. This will ensure that your “approval” is a success and that your devices are quickly launched on the market.
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