Glossary of key terms
Definitions are drawn from the UK Medical Devices Regulations 2002 (SI 2002/618, as amended), MHRA guidance, and ISO standards referenced in the UK regulatory framework. Where UK definitions differ meaningfully from EU MDR 2017/745 equivalents, this is noted.
A
AIMD (Active Implantable Medical Device) A device intended to be totally or partially introduced, surgically or medically, into the human body and to remain after the procedure, which depends for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity. Pacemakers, ICDs, and cochlear implants are AIMDs. Governed by Part II of UK MDR 2002. All AIMDs require full UK Approved Body assessment.
Accessory (to a medical device) An article which, while not itself a medical device, is intended by its manufacturer to be used together with a specific medical device to enable or assist that device to be used in accordance with its intended purpose. Accessories are regulated as medical devices in their own right.
Annex II List A / List B The two lists in Annex II of Part III of UK MDR 2002 that identify IVD medical devices requiring UK Approved Body involvement. List A contains the highest-risk IVDs (e.g., HIV detection, blood group typing). List B contains significant-risk IVDs (e.g., rubella, PSA, blood glucose for professional use).
Authorised Representative A person established in the UK explicitly authorised in writing by a manufacturer to act on the manufacturer's behalf with MHRA. For non-UK manufacturers, the UKRP typically serves this function.
B
Borderline product A product that may or may not be a medical device — sitting on the boundary between medical devices and medicines, cosmetics, biocides, or food supplements. MHRA publishes borderline guidance and can provide informal opinions on specific products.
BSI (British Standards Institution) The UK's national standards body. BSI publishes and maintains UK standards (BS/EN/ISO) relevant to medical devices. BSI is also a designated UK Approved Body (UKAB) for medical device conformity assessment.
C
CE mark The conformity mark of the European Union, required for devices placed on the EU market and the Northern Ireland market. Currently accepted on the Great Britain market under transitional arrangements until 30 June 2030. The CE mark is not the same as the UKCA mark and cannot be used as a substitute after transitional acceptance ends.
CER (Clinical Evaluation Report) The document that summarises the clinical evidence for a medical device — demonstrating that the device's clinical benefits outweigh its risks for its intended purpose. Must be maintained and updated throughout the device's market life.
Combination product A product combining a medical device and a medicinal substance (or biological product) in an integral presentation. Classification as a device or medicine depends on the principal mode of action. See Devices incorporating a medicinal substance.
Conformity assessment The process by which a manufacturer demonstrates that their device meets the Essential Requirements of UK MDR 2002. May involve self-declaration (lower-risk devices) or UK Approved Body involvement (higher-risk devices).
Custom-made device A device manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner giving, under their responsibility, specific design characteristics, intended for the sole use of a particular patient. Custom-made devices have modified conformity assessment requirements under UK MDR 2002.
D
Declaration of Conformity (DoC) A document issued by the manufacturer declaring that their device meets all applicable Essential Requirements of UK MDR 2002. The DoC must be signed, dated, and maintained. For non-UK manufacturers, the UKRP's details may be included. Equivalent to the EU Declaration of Conformity.
Designated standard A standard published in the Official Journal of the UK (or designated by MHRA/BSI) which, when applied in full, provides a presumption of conformity with the Essential Requirements to which it relates. Equivalent function to harmonised standards in the EU.
Distributor Any natural or legal person in the supply chain — other than the manufacturer or importer — who makes a device available on the GB market. Distributors must verify UKCA/CE marking and labelling compliance before supplying.
DHSC (Department of Health and Social Care) The UK Government department responsible for health policy. DHSC sets the policy framework for medical device regulation; MHRA implements it as an executive agency.
E
Economic operator Any of the entities involved in the supply chain for medical devices who have defined obligations under UK MDR 2002: manufacturer, UKRP, importer, and distributor.
Essential Requirements The fundamental safety and performance requirements that all medical devices placed on the GB market must meet. Set out in Schedule 1 (general devices and AIMDs) and Schedule 1A (IVDs) of UK MDR 2002. Equivalent to the General Safety and Performance Requirements (GSPR) under EU MDR 2017/745, though less detailed.
F
FSCA (Field Safety Corrective Action) An action taken by a manufacturer to reduce a risk of death or serious deterioration in health associated with the use of a device that is already on the market. FSCAs must be reported to MHRA and communicated to users via a Field Safety Notice (FSN).
FSN (Field Safety Notice) A communication from a manufacturer to device users, distributors, or healthcare professionals notifying them of an FSCA. FSNs must be reported to MHRA and are typically published on the MHRA website.
G
Great Britain (GB) England, Scotland, and Wales. The territory where UK MDR 2002 and UKCA marking requirements apply. Distinct from Northern Ireland, where EU MDR/IVDR apply. The United Kingdom comprises GB and Northern Ireland.
I
Importer Any natural or legal person established in the United Kingdom who places a device from a third country on the GB market. Importers have verification and traceability obligations under UK MDR 2002.
In vitro diagnostic (IVD) medical device A medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system intended to be used in vitro for the examination of specimens derived from the human body. Governed by Part III of UK MDR 2002.
Intended purpose The use for which a device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use, and/or in promotional materials. Intended purpose is the starting point for determining whether a product is a medical device and how it should be classified.
IFU (Instructions for Use) The document supplied with a device providing all necessary information for safe and effective use by the intended user. IFU requirements are specified in the Essential Requirements (Schedule 1, UK MDR 2002).
ISO 13485 The international standard specifying requirements for a Quality Management System for organisations involved in the design, production, installation, and servicing of medical devices. MHRA expects manufacturers and many economic operators to maintain a QMS to ISO 13485.
ISO 14971 The international standard for the application of risk management to medical devices. Risk management to ISO 14971 is a core expected element of UK MDR 2002 technical documentation.
IVD See In vitro diagnostic (IVD) medical device.
M
Manufacturer Any natural or legal person who designs and/or manufactures a medical device with a view to placing it on the market under their name, whether or not such a device is actually designed and/or manufactured by that person themselves or by someone else on their behalf. Manufacturers bear the primary regulatory obligations under UK MDR 2002.
MHRA (Medicines and Healthcare products Regulatory Agency) The executive agency of the UK Department of Health and Social Care responsible for regulating medical devices (and medicines, blood, and tissues) in the United Kingdom. MHRA is the sole competent authority for medical devices in GB and also acts as a competent authority for Northern Ireland.
MHRA Submissions portal The online portal used for registering manufacturers, UKRPs, and devices with MHRA. Registration via the portal is mandatory for all parties placing devices on the GB market.
N
Northern Ireland (NI) The part of the United Kingdom where EU MDR 2017/745 and EU IVDR 2017/746 apply — not UK MDR 2002. Northern Ireland's regulatory alignment with the EU is maintained under the Windsor Framework. MHRA acts as the competent authority for NI but in an EU regulatory context.
P
PER (Performance Evaluation Report) The document summarising the analytical and clinical performance evidence for an IVD medical device. Equivalent to the CER for general medical devices.
PMCF (Post-Market Clinical Follow-up) A structured process for collecting and evaluating clinical data from devices already on the market to confirm the ongoing safety and performance of the device, identify previously unknown risks, and update the clinical evaluation. A PMCF plan and report must be maintained for all devices.
PMS (Post-Market Surveillance) The systematic process of proactively collecting and reviewing experience gained from devices placed on the market. Manufacturers must have a documented PMS plan and report. PMS data feeds into the risk management file and clinical evaluation.
PSUR (Periodic Safety Update Report) A report summarising PMS conclusions and confirming the device's benefit-risk ratio. Required for Class IIa (at least every 2 years), Class IIb, III, and AIMD (at least annually).
Placing on the market The first making available of a device on the GB market other than for the purpose of clinical investigation. A device is placed on the market when it is supplied to a distributor or user in GB for the first time.
Q
QMS (Quality Management System) A documented system of policies, processes, and procedures ensuring consistent product quality and regulatory compliance. ISO 13485 is the primary QMS standard for medical device manufacturers. MHRA expects manufacturers to operate a QMS throughout the device lifecycle.
R
Risk management The systematic application of policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk associated with a medical device throughout its lifecycle. Governed by ISO 14971. Required for all devices as part of the Essential Requirements.
S
SaMD (Software as a Medical Device) Standalone software that qualifies as a medical device by virtue of its intended purpose. Software that analyses data and produces clinically meaningful output (e.g., diagnoses, recommendations) is likely a medical device. Software that merely stores or transfers data is not.
Serious incident An incident that directly or indirectly led, might have led, or might lead to the death of a patient, user, or other person, a temporary or permanent serious deterioration of the state of health of a patient, user, or other person, or a serious public health threat. Serious incidents must be reported to MHRA within statutory timeframes.
Sponsor In the context of clinical investigations, the individual, company, institution, or organisation that takes responsibility for the initiation, management, and financing of a clinical investigation. The sponsor may or may not be the device manufacturer.
T
Technical file The set of documents demonstrating that a medical device conforms to the Essential Requirements of UK MDR 2002. Must be maintained throughout the device's market life and made available to MHRA or a UKAB on request.
Trend report A report submitted to MHRA when a manufacturer identifies a statistically significant increase in the rate of incidents that are not themselves required to be individually reported as serious incidents. Trend reporting is a UK MDR 2002 vigilance requirement.
U
UKAB (UK Approved Body) An organisation designated by MHRA to carry out third-party conformity assessment of medical devices. UKABs are the UK equivalent of EU Notified Bodies. UKAB involvement is required for Class IIa, IIb, III, AIMD, IVD List A, List B, and self-test devices. UKAB certificates are valid for the GB market only.
UKCA mark The UK Conformity Assessed mark. The conformity mark for the Great Britain market, replacing CE marking for devices that complete conformity assessment against UK MDR 2002. The UKCA mark is not accepted in the EU or Northern Ireland.
UKNI indication A mark applied alongside the CE mark to indicate that the device has been assessed by a UK Approved Body for the Northern Ireland market. Products bearing UKNI may be placed on the GB and NI markets but not on the EU market.
UKRP (UK Responsible Person) A legal or natural person established in Great Britain appointed by a non-UK manufacturer to act as their legal representative with MHRA for the GB market. The UKRP registers the manufacturer and devices with MHRA, maintains documentation, and reports adverse events. The UKRP's name and address must appear on device labels.
UDI (Unique Device Identifier) A numeric or alphanumeric code associated with a specific medical device that allows unambiguous identification of devices on the market. UDI requirements are being implemented in the UK. MHRA has published guidance on UDI requirements and timelines.
V
Vigilance The post-market process of reporting serious incidents and FSCAs to MHRA. The UK MDR 2002 vigilance system requires manufacturers to report within defined timeframes based on incident severity. Reports are submitted via the MHRA Yellow Card scheme or Submissions portal.
W
Windsor Framework The political agreement between the United Kingdom and the European Union (March 2023) that replaced the Northern Ireland Protocol and governs Northern Ireland's continued alignment with EU single market rules for goods — including medical devices. Under the Windsor Framework, EU MDR 2017/745 and EU IVDR 2017/746 continue to apply in Northern Ireland.
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Reg 2(1) | Primary definitions |
| SI 2019/791 | Post-Brexit amendments and UKRP definitions |
| MHRA: Glossary of regulatory terms | MHRA's own glossary |
| ISO 13485:2016 | QMS definitions |
| ISO 14971:2019 | Risk management definitions |
| MHRA: Regulating medical devices in the UK | Key terms in context |