Mobile medical devices

We are witnessing an explosive growth in medical devices that use wireless technologies. Some devices are implanted and some are worn on the body to control bodily functions and to measure an array of physiological parameters. The data from these sensors and monitoring equipment, together with patient observations of daily living, can be transmitted wirelessly to another location for review by relevant specialists.

Mobile devices allow for remote management of patients with a range of chronic diseases or patients recovering at home. Mobile medical applications are also transforming healthcare. Examples include apps that measure heart rate and blood pressure, perform an ECG, manage the delivery of insulin, take patient-specific information and provide a clinician with radiation dosage calculations, and allow doctors to view X-rays or other imaging on smart phones and tablets.

A device falls under the scope of the EU MDD or MDR, or the UK MDR (2002), if it has a medical purpose as defined in the Directive or Regulations; please note that products without a medical purpose need to meet separate requirements. Areas for consideration:

• Risks associated with design, manufacture and use should be managed as part of a comprehensive quality management system by, ideally, applying EN ISO 14971
• Data integrity and security are concerns particularly when the data is transmitted wirelessly
• Usability compliance can most easily be demonstrated by meeting the requirements in the standard EN 62366 in the design process. If the device is for home use, studies should be carried out on samples of target users
• Software lifecycle processes become an important part of the design process. An applicable standard in this area is EN 62304
• Electromagnetic compatibility should be considered as an integral part of the development lifecycle. Wireless devices also fall under the scope of the Radio Equipment Directive (RED) so the EN 301 489 and EN 60601-1-2 series of standards will likely apply
• You should also ensure that the device complies with the safety and essential performance requirements contained in the EN 60601 family of standards
• When designing any medical device, you must perform extensive clinical data evaluations to ensure patient safety

Unless the regulatory framework and requirements are taken into account in the early stages of the design process, you could find yourself needing to invest significant additional time and resources to obtain regulatory approval.

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 mobile medical devices and can support you through the process of certifying your device.

BSI’s mobile device experience includes:

• Integrated device recognition using RFID
• Video capsule endoscopy
• Devices to assist movement of artificial limbs
• Mobile medical device apps
• Ingestible sensors
• Implanted wireless sensors and devices
• Wearable wireless sensors and devices

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.

The process of CE or UKCA marking a mobile medical device requires that you, as a manufacturer, fully understand the requirements applicable to your device and have clear, compliant and complete documentation. For CE marking, we have developed MDR Best Practices Guidelines to assist with this.