Software as a medical device

The first stage is to confirm your product or service is legally classified as an SaMD; the product must first have a stated intended purpose that is medical as defined by the Medical Device Directives and Regulation in the EU and the UK Medical Devices Regulation (UK MDR) 2002.

The European Commission’s guidance, MEDDEV 2.1/6, is only applicable to standalone software.

As indicated in the EU MDD/MDR and UK MDR, standalone software which has a medical purpose is considered to be an active medical device. Classification depends on the risk to the patient and users. To classify your software fully, you will need to review the relevant classification rules.

Before you start to develop your medical device software, identify the relevant Directives and Regulations, standards, and guidance documents recommended to develop, maintain, and validate medical software according to the State of the Art. The diagram below contains the documents you should consider as a starting point. Early consideration of the regulatory requirements will reduce the need to rework your software later in the development cycle.

Consider who will use the software, and ensure the user interface is suitable for your target operator; different language and knowledge should be assumed based on the software being used by a patient directly or a clinician.

It is critical to work with an EU notified body or UK approved body that understands the industry and has the experience to review and confirm your product’s readiness for market – efficiently, reliably and promptly. Our technical specialists have extensive experience in certifying software as a medical device and can support you through the process of certifying your software.

BSI’s SaMD experience includes:

• infusion pump rate setting assistance software
• picture Archiving and Communication Software (PACS)
• image processing software
• standalone application software for remotely collecting patient data for clinicians to analyze
• standalone software used to program and collect data from implantable devices
• apps for phones (e.g. ECG, ophthalmic assessments and radiation therapy planning software)

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.