The regulations and literature surrounding medical device development are packed with acronyms and technical terms, assuming a shared understanding of key industry requirements and processes.
With so many governmental certifications and regulatory bodies overseeing the safe design, production and marketing of these products worldwide, the use of abbreviations and technical terms can proliferate. These often overlap with each other, describing different or even identical processes and concepts.
As you read around the subject and have discussions with professionals from various organisations, it can be hard to keep track of the meaning and relevance of all the terminology and acronyms currently in use.
Beyond the med tech acronyms – what do they all mean?
So, with this in mind – here is an A- Z of some of the most common and more obscure technical terms and abbreviations (together with their definitions) that med-tech device developers can encounter in the literature, and their dealings with regulators and collaborators across the globe.
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A glossary of regulatory terms for medical device developers
AIMD – Active Implantable Medical Device
An (AIMD) is a device intended to be partially or completely implanted into the body, where it is meant to stay for an extended amount of time. Due to the technical complexity and high-risk profile of these devices, they are among the most expensive and time-consuming to develop. You can read more about the global medical device definitions and classifications in this blog.
Approved Bodies
Approved Bodies are the organisations that have been designated by the UK MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Devices Regulations 2002. They are the post-Brexit equivalent of EU Notified Bodies. You can visit the UK government website for a full list of UK Approved Bodies.
BOM – Bill Of Material
A list of raw materials, components and subassemblies that make a product.
CA – Competent Authority
Each member state in the European Economic Area appoints a competent authority to perform certain functions required by Directive (2001/20/EC). Following Brexit, the MHRA remains the UK’s licensing authority for pharma and medical devices – and is the competent authority for the UK.
CA – Conformity Assessment
In the EU, conformity with required regulatory standards can be self-assessed or carried out by a Notified Body depending on the classification of the device in question. Conformity Assessment must be successfully carried out before a CE marking can be awarded and a product sold in the EU.
CAPA – Corrective Action Preventive Action
CAPA requirements are the regulatory demands ensuring a developer has clearly documented procedures for correcting and preventing existing and future nonconformities in their products and processes.
CE marking – European Conformity Marking
A CE marking (abbreviated from the French – ‘Conformité Européenne’) is a certification mark that indicates conformity with medical device standards for products sold within the European Economic Area. You cannot legally sell a device in the EU without this marking.
Corrective Action
A corrective action is a formal part of a CAPA process mandated by ISO 13485 and medical device regulators around the world. It describes the process of investigating and eliminating the cause of a detected nonconformity in a product.
Design Dossier
A term used in the European MDD (Medical Device Directive) but which does not appear in the new EU MDR (Medical Device Regulation) which came into force in 2020. It should be noted that the term ‘design dossier’ has now been replaced by the term ‘technical documentation’ in the EU MDR.
DFM – Design For Manufacture
The process of designing a product with ease of manufacturing in mind, often with an end goal of making a better product at a lower cost.
DHF – Design History File
A design history file is a repository for all records that demonstrate how your medical device was developed in accordance with an approved design plan. ISO 13485 and the FDA require developers to maintain a DHF for each type of device in their portfolio.
DHR – Device History Record
The DHR is an FDA term for the combination of records containing the entire production history of a finished medical device.
DMR – Device Master Record
A Device Master Record is an FDA requirement. It is a compilation of all the instructions, drawings, documented specifications, labelling and packaging requirements that must be used to produce your medical device. It is the definitive instruction manual for the safe and effective production of your device.
DoE – Design of Experiment
A systematic method to determine the relationship between factors affecting a process and the output of the process (cause and effect relationship).
EO – Economic Operators
‘Economic Operators’ are the entities who share responsibility for the compliance of medical products in the supply chain. They are defined in Article 2 of the MDR and IVDR as the manufacturers, importers, distributors and their ‘authorised representatives’ who create, market and deliver products across the EU.
Equipment calibration
Equipment calibration is the process of comparing the readings gathered from a measuring device to a known standard. The goal is to ensure that any equipment used in design and development is always giving accurate readings and to re-calibrate them, if required. Equipment calibration is a formal process required by ISO 13485:2016 and medical device regulators around the world. These processes must be documented and regularly undertaken by medical device developers to build compliant devices.
DP – Detail Part (drawing)
A drawing containing sufficient information to allow effective production of a part.
DQ – Design Qualification
Documented verification that the proposed design of the device is suitable for the intended purpose.
EDS – Engineering Design Specification
A document detailing the requirements that must be met in order for the product to meet the User Requirement Specification
EU IVDR – In Vitro Device Regulation
The EU Medical Device Regulation 2017/746 which governs the development of all In Vitro medical devices for sale in the European Economic Area. The IVDR has been applicable since 26 May 2022,
For IVD products did not previously require notified body approval and which had acquired IVDD declarations of conformity prior to 26 May 2022, the applicable IVDR transitional period depends on the class of the IVD in question:
- Class D – 26 May 2025;
- Class C – 26 May 2026;
- Class B and relevant Class A devices – 26 May 2027.
EU MDR – Medical Device Regulation
The EU Medical Device Regulation 2017/745 governs the development of general medical devices for sale in the European Economic Area. The Medical Devices Regulation entered into force in May 2017 and became applicable on 26 May 2021. The transition period provided for in the regulation will end on 26 May 2024.
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FDA 21 CFR Part 11
Part 11 sets out how a company operating in the US should use electronic quality records and digital signatures in place of paper-based documentation and ‘wet signatures’ in a compliant way.
FDA 21 CFR 820
Also known as the QSR, this set of FDA regulations mandates the establishment and maintenance of a robust Quality Management System (QMS) to ensure the safety and quality of medical devices throughout their lifecycle.
FDA 483
The FDA 483 is a form used by the U.S. Food and Drug Administration (FDA) during inspections to document and communicate observations made by their investigator regarding potential violations of regulatory requirements. When the FDA conducts an inspection of a regulated establishment, such as a pharmaceutical company or medical device manufacturer, they may issue a Form FDA 483 if they find any deviations from applicable laws and regulations. A warning letter may be received following this initial communication and is considered an escalation from a 483 observation.
FEA – Finite Element Analysis
A computerised method for predicting how a product reacts to real-world forces, vibration, heat, fluid flow, and other physical effects.
FDA 510 (K)
A 510(K) is a premarket submission made to the FDA to demonstrate that a device to be marketed is as safe and effective as another legally marketed device that is not subject to premarket approval (PMA).
FMEA – Failure Mode Effects Analysis
FMEA is a structured approach to discovering potential failures that may exist within the design of a medical device product or process. It is a model used to prioritise potential defects of a medical device based on their severity, expected occurrence and likelihood of detection.
FTA – Fault Tree Analysis
A top down, deductive failure analysis in which an undesired state of a system is analysed using Boolean logic to combine a series of lower level events.
FTO – Freedom To Operate
Determining whether testing or commercialising a product can be done without infringing valid intellectual property rights of others.
GAMP – Good Automated Manufacturing Practice
GAMP are the guidelines for companies involved in the development and implementation of automated manufacturing systems for the Pharmaceutical and Food Industries.
GCP – Good Clinical Practice
GCP are the ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve human beings. This is vital for the medical device and IVD industry.
GDP – Good Distribution Practice
GDP governs the wholesale distribution of medical devices and other medical products. It is designed to ensure quality and integrity is maintained throughout the supply chain.
GDocP – Good Documentation Practice
GDocP are the standards by which data and documents should be created and maintained in the life sciences industry.
GLP – Good Laboratory Practice
These are principles which ensure the quality and integrity of non-clinical laboratory studies that support research or marketing permits for products regulated by government agencies.
GMP – Good Manufacturing Practice
GMP also referred to as cGMP (Current Good Manufacturing Practice) are regulatory requirements designed to ensure pharmaceutical products, medical devices and other items are consistently manufactured and controlled according to quality standards – thus reducing the risk of harm to consumers.
GxP – Good Practice Guidelines
GxP are the ‘good practice’ guidelines and regulations created by various regulators to ensure that life science products are safe, effective and usable. The ‘X’ in GxP can refer to a number of disciplines – For example, GMP (Good Manufacturing Practice) or GLP (Good Laboratory Practice).
Taken together they define the ways companies in regulated industries are required to control their processes, procedures, people and premises to ensure consistency and quality in their products and services.
HID – Hazard Identification
Identification of potential conditions, events or circumstances that could lead to, or contribute to an unplanned or undesirable event.
IFU – Instructions For Use
Information provided by the manufacturer to inform the device user of the medical device’s intended purpose, proper use and any precautions to be taken.
IP – Intellectual Property
Intangible property that is the result of creativity, such as patents, copyrights, designs, inventions, etc.
ISO 13485: 2016
ISO 13485:2016 is the recognised Quality Management standard for medical device regulators around the world.
MDD – Medical Device Directive
The abbreviation for the EU Medical Device Directive which is now superseded by the EU MDR and EU IVDR.
MDF – Medical Device Technical File
In ISO 13485, the Medical Device Technical File is the technical documentation (TD) that includes descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria and more. A medical device file must be kept for every device in your portfolio. For more details about the technical documentation requirement, see below.
NB – Notified Body
A notified body is an organisation designated by an EU country to assess the conformity of certain medical devices. Notified Bodies carry out conformity assessment procedures set out in the legislation when a third party is required to do so.
NC – Non-conformance
A non-conformance or non-conformity, is any output that doesn’t meet requirements, specifications or expectations. Non-conformities can arise in materials, products, and software, as well as in services and working practices.
NCR – Non-conformance reports
A non-conformance report is a formal filing of detected non-conformances in a product or service. Non-conformance reporting is a requirement of ISO 13485 and is a critical part of any medical device developers’ CAPA process.
Download your non-conformance report template here
PCB – Printed Circuit Board
Collection of electronic components connected via conductive tracks on a non-conductive board.
PIL – Patient Information Leaflet /Packaging Insert Leaflet
Information provided by the manufacturer about doses, side effects and contraindications for a pharmaceutical product or a drug/device combination product.
PMA – Premarket approval
Premarket Approval (PMA) is the process of scientific and regulatory review through which the FDA evaluates the safety and effectiveness of Class III medical devices. This blog post describes the difference between the FDA’s process of 51oK clearance and PMA.
Post-market surveillance (PMS)
Post-market surveillance refers to the ongoing monitoring and evaluation of medical devices, pharmaceuticals, or other regulated products after they have been approved or cleared for marketing and are being used by patients or consumers. It is an essential component of regulatory systems to ensure the continued safety, effectiveness, and quality of these products throughout their lifecycle.
PoP – Proof of Principle
The realisation of a method or idea to demonstrate its feasibility.
PRS – Product Requirement Specification
Definition of requirements needed to be achieved in order for the product to meet the User Requirement Specification.
Preventive Actions
Preventive actions are the proactive measures taken by manufacturers to identify, prevent, or minimise potential risks or problems associated with their devices. It is an essential component of a CAPA system to ensure the safety and effectiveness of medical devices throughout their lifecycle
QA – Quality Assurance
Quality Assurance (QA) refers to the processes and procedures implemented by a company to ensure that its products or services always meet a certain level of quality.
QC – Quality Control
Quality Control (QC) are the tests carried out to ensure products work as intended before they are distributed. Typical QC activities include batch testing and sampling to ensure consistency of output.
QMS – Quality Management System
A QMS formally documents the processes, procedures, and responsibilities for achieving quality policies and objectives in the development and management of your medical device.
A QMS can be a paper based or digital system.
RA – Risk Analysis
Systematic use of available information to identify hazards and eliminate risk.
RMP – Risk Management Plan
A documented plan for the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk.
SaMD – Software as a Medical Device
Software as a Medical Device (SaMD) refers to any software application that performs a medical function without being part of a hardware medical device. This could range from an app on a smartphone that helps monitor your heart rate, to a cloud-based system that analyses medical imaging data to detect abnormalities.
SOP – Standard Operating Procedure
A SOP is a detailed written instruction used to achieve uniformity in the performance of a specific function.
STED – Summary Technical Documentation
One of the best known proposals for structuring technical documentation comes from the IMDRF (International Medical Device Regulation Forum). Many authorities and notified bodies use the STED (Summary Technical Documentation) as a guide for this activity.
TD – Technical Documentation
The EU MDR and IVDR require ‘technical documentation’ (once referred to as the Design Dossier or Technical File) to be maintained and auditable for every device in your portfolio. This technical documentation is used to prove that a product has been designed according to the requirements of a quality management system and the relevant regulation.
TI – Task Instruction
Detailed written instructions to achieve uniformity of the performance of a task.
TPR – Test Protocol
Detailed written document that outlines the requirements, activities, resources, documentation and schedules to be completed in order to execute a test.
UET – User Event Tree
A bottom up, causal failure analysis in which an undesired state of a system caused by the user is analysed using Boolean logic to model risk.
UKCA marking
The UKCA mark is the symbol affixed to medical devices, indicating their compliance with the regulations outlined in the UK MDR 2002. It indicates that the device meets the necessary standards for its intended purpose and adheres to safety legislation. it shows that the product can be lawfully marketed within Great Britain, encompassing England, Wales, and Scotland.
UKRP – UK Responsible Person
The UK Responsible Person, also known as the UKRP, is a designated entity or individual appointed by a manufacturer outside of the United Kingdom (UK) to represent them and fulfil specific obligations under the UK medical device regulation.
URS – User Requirement Specification
A document specifying what the user requires the product to do.