Such devices allow for remote management of patients with a range of chronic diseases or patients recovering from stroke, for instance. 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 Medical Device Directive if it has a medical purpose as defined in the Directive. Areas for consideration include:
- 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 harmonised 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 harmonised standard in this area is EN 62304.
- Electromagnetic compatibility should be considered as an integral part of the development lifecycle. Wireless devices and products that are wired to the telecoms network, also fall under the scope of the R&TTE Directive so the EN 301 489 series of standards will most likely apply.
- You should also ensure that the device complies with the safety and essential performance requirements contained in the EN60601 family of standards.
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.
