UK Medical Device Regulations (MDR) Glossary: What every medical device engineer should know
Reading time 12 mins
Key Points
- As demand for healthcare technologies increases, rushing to get products to the market by cutting corners can have serious consequences
- UK medical device regulations (UK MDR) exist to ensure that products are safe, efficient and compliant; but also to avoid worst-case scenario of product recalls
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. Each country (e.g. USA) and region (e.g. Europe) has its own regulatory body that medical device engineers should comply with in accordance to the market in which their product will be placed
- Navigating regulations, directives, standards, and conformity assessments can be challenging
- A list of key terminology that medical device engineers and quality managers should know is helpful to having a strong foundation from which to develop medical devices
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Digital Healthcare is one of the fastest-growing markets globally. As increased demand for healthcare technologies fuels investor excitement, companies that rush to get their products to market to gain a competitive edge by cutting corners (e.g. inadequate testing) risk having those products recalled at a later stage. Product recall is any developer or medical device engineer’s worst nightmare. Not only can this lead to significant financial and reputational losses, but in the worst-case scenario: injury or loss of life. UK medical device regulations (UK MDR) exist to ensure that the products we design are safe, efficient, effective, and of the highest quality, thereby avoiding worst-case scenarios.
At the same time, these regulations – which can differ from one country/region to the next – can be a minefield to navigate. Below is a glossary of core medical device regulations (MDR) every engineer or quality control manager should know. It’s not an extensive list, but it’s comprehensive and should help you build a solid foundation from which to develop your medical device or product.
Regulatory bodies for medical devices
| REGION | REGULATORY BODY | ACRONYM | ROLE |
| United Kingdom | Medicines and Healthcare products Regulatory Agency | MHRA | Responsible for regulating the UK medical devices market |
| Europe | European Medicines Agency | EMA | Evaluates the quality, safety, and performance of medical devices in relation to their use with a medicinal product |
| Medical Device Regulation | EU MDR | Ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union | |
| In Vitro Diagnostic Device Regulation | EU IVDR | Regulations for manufacturers, importers, distributors, or quality management professionals involved with in vitro diagnostic devices | |
| USA | Food & Drug Administration | FDA | Regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products |
| International | International Medical Device Regulators Forum | IMDRF | Medical device regulators from around the world who harmonise the regulatory requirements for medical products that vary from country to country |
UK Medical Device Regulations Terminology
Please note that the terms and definitions listed below relate mostly to UK medical device regulations. Although most are also common EU medical device terminology , some may differ from one country to the next.
| TERM | ACRONYM | DEFINITION |
| Active Implantable Medical Device | AIMD | Any active medical device intended to be introduced into the human body for diagnostic or therapeutic purposes and which is intended to remain in place, e.g. pacemakers or defibrillators |
| Adverse incident/event | An event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons | |
| Artificial Intelligence as a Medical Device | AIaMD | Devices employed to fulfill human capabilities in a variety of roles with deep learning techniques using neural networks, e.g. disease prevention and diagnosis |
| Auditing Organisations | AOs | The bodies that carry out Medical Device Single Audit Program (MDSAP) assessments |
| Conformité Européenne | CE | Stamp proving that products sold have been assessed to meet high safety, health, and environmental protection requirements |
| Certificate of Conformity | Show that the device complies with the UK medical devices regulations | |
| Classification | General medical devices are classified into four classes of increasing levels of risk: Class I, IIa, IIb or III in accordance with criteria in the UK medical devices regulations | |
| Clinical Evaluation Plan | CEP | The collection of clinical data and clinical evaluation results that demonstrate safety and performance |
| Corrective and Preventive Actions | CAPA | Clearly documented procedures for corrective and preventive action as part of an overall Quality Management System |
| Custom Made Medical Device | Manufactured strictly in accordance with a written prescription and intended for the sole use of a particular person | |
| Declaration of Conformity | DoC | A declaration that the device complies with the UK medical devices regulations |
| Directive 90/385/EEC on medical devices | EU MDD | Regards any medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure |
| Directive 90/79/EC on active implantable medical devices | EU AIMDD | Regards any active medical device that relies on electrical energy or a power source other than that directly generated by the human body or gravity |
| Directive 98/79/EC on in vitro diagnostic medical devices | EU IVDD | Regards testing devices used on biological samples (such as tissues, blood or urine) to determine the status of a person’s health (e.g. pregnancy) |
| Domestic assurance | The process through which UK Approved Bodies can perform an abridged assessment of a device with appropriate levels of scrutiny to ensure that it meets the requirements of the UK medical devices regulations, as well as an assessment of the manufacturers | |
| EU Notified Bodies | Organisations designated by EU member states to assess the conformity of certain products before being placed on the market | |
| Field safety corrective action | FSCA | An action by a manufacturer to reduce the risk of death or serious deterioration in the state of health associated with the use of a medical device, i.e. can be a device recall, modification, retrofit or design change, or device destruction |
| Global Medical Devices Nomenclature | GMDN | A list of generic names used to identify all medical devices |
| Grandfathering | A legacy medical device that was already on the market before an applicable directive or regulation | |
| Health Institution Exemption | HIE | An exemption from all the requirements of the UK medical devices regulations that applies to medical devices and in vitro diagnostic medical devices (IVDs) that are used in the same health institution in which they are manufactured |
| Instructions for use | IFUs | The information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken |
| International Electrotechnical Commission | IEC | Prepares and publishes international standards for all electrical, electronic and related technologies |
| IEC 62304 | The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes | |
| IEC 60601-1 | Applicable to embedded software in a hardware medical device | |
| IEC 82304-1 | Applicable to standalone software, also known as Software as a Medical Device (SaMD) | |
| IEC 81001-5-1 | Requirements regarding cybersecurity | |
| IEC 62366-1 | Requirements regarding man-machine interface ergonomics | |
| International Organisation for Standardization | ISO | A worldwide federation of national standards bodies |
| ISO 13485 | Requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements | |
| ISO 14971 | Process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. |
| Medical Device | A piece of equipment that comes into direct contact with the patient and is used to treat or diagnose a clinical condition | |
| Medical Device Single Audit Programme | MDSAP | A route to market that would allow a single regulatory audit of a medical device manufacturer’s Quality Management System (QMS) that would meet the requirements of multiple regulatory jurisdictions |
| Medicinal Product | A substance or combination of substances intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action | |
| Post-market surveillance | All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service to identify any need to immediately apply any necessary corrective or preventive actions | |
| Quality Management System | QMS | A system intended to ensure that manufacturers consistently design, produce, and place onto the market medical devices that are safe and fit for their intended purpose |
| Risk Management System | RMS | Involves the identification, understanding, control, and hazard prevention during device use |
| Serious adverse incident/event | Critical device-related adverse incidents (e.g. device malfunction, deterioration in device performance, inadequate instructions) that may or may not result in death or serious injury | |
| Software as a Medical Device | SaMD | Standalone software and apps that meet the definition of a medical device (including AI as a medical device (AIaMD)) |
| UK Approved Bodies | Previously known as ‘notified bodies’, UK Approved Bodies are used where third-party conformity assessment is required to place products on the Great Britain market (England, Scotland, Wales) | |
| UK Conformity Assessed | UKCA | A UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland) |
| Unique Device Identifier | UDI | A series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard |
| Yellow Card Scheme | The UK system for collecting and monitoring information on safety concerns, such as suspected side effects or adverse incidents involving medicines and medical devices |
Final regulatory advice for medical device engineers
If you found this post on UK medical device regulations helpful, we suggest you read our related posts on medical design tips for engineers and how to consider human factors for user-centered design.
In our next series of posts, we’ll take a more detailed look into regulatory factors and proposed reforms impacting the digital healthcare industry. Please let us know if you have any questions: we can’t guarantee we’ll have all the answers, but we’ll help you find them.
Comments
- FINAL Consultation Medical Devices Regulations. (n.d.). GOV.UK. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1018219/Glossary_PDF.pdf
- [Glossary] EU MDR and IVDR: The core terms you should know. (n.d.). SoftGroup. Retrieved 30 November 2022, from https://www.softgroup.eu/2020/10/19/eu-mdr-and-ivdr-glossary/
- Medical devices regulation and safety: detailed information. (n.d.). GOV.UK. Retrieved 30 November 2022, from https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety
- Michaud, C. (2011, November 1). ISO and IEC standards for software in medical devices in a nutshell – Software in Medical Devices, by MD101 Consulting. Property of Cyrille Michaud CC-BY-ND License. https://blog.cm-dm.com/post/2011/11/01/ISO-and-IEC-standards-explained-to-software-engineers-and-quality-managers
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