Guidance on Medical Devices
A piece of equipment is defined as a medical device by the Medicines and Healthcare products Regulatory Agency (MHRA) if it is:
“Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”
Useful Links:
- The MHRA guidance for medical devices can be found here.
- The HRA have launched a series of eLearning modules including the regulations and considerations for clinical investigations of medical devices
- The MHRA have also published information on when software applications are considered to be a medical device and how they are regulated. This will be useful to you or your research group if you are working on a software application that is likely to be used as a medical device.
- The MHRA gives access to the three EU Directives concerning medical devices: 93/42/EEC; the medical device directive, 90/385/EEC; the directive on implantable medical devices and 98/79/EC; the directive on vitro diagnostic medical devices
- Relevant standards that apply to the manufacture, conduct, risk assessment of medical device trials are listed here.
ISO Standards for Medical Devices
Other relevant standards:
ISO 20916:2019 - In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
Software related standards:
ISO 9001:2015 - Quality management systems – Requirements
ISO 15189:2022 - Medical laboratories – Requirements for quality and competence
ISO 22301:2019 - Security and resilience – Business continuity management systems
If you are unable to download the ISO standards, please try clearing your browser cookies and accessing the document via the this link.
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Please note that if you are undertaking a study that uses a non-CE marked device, you may need approval from the Head of Clinical Engineering.
The Clinical Trials team introduced new SOPs for medical devices. These include:
- Good Documentation Practice
- Quality Control
- Hosting Regulatory Inspections
- Medical Device Risk Assessment
- Non-Conformance, Root Cause Analysis, and CAPA
If you intend to undertake any research within the university which may involve the use of equipment which may be a medical device, or is a known medical device but will be used outside of its intended purpose and be tested on human participants, then please contact at the earliest opportunity:
Dr Mohammed Zubair - Research Governance, Ethics, and Integrity Manager
Directorate of Research and Business Engagement
Christie Building
The University of Manchester
Manchester, M13 9PL
Email: (medicaldevices@manchester.ac.uk)
Tel: 0161 275 2725