The global market for medical devices is defined by stringent and often complex regulatory requirements. For organizations developing, manufacturing and distributing these products, ensuring the quality of documentation is vital.
To protect patient safety and mitigate compliance risk, documentation like the Instructions for Use (IFU) and Technical File must maintain their integrity across all languages. Which is where Responsive Translation can help. Certified for both ISO 9001 and ISO 13485, Responsive Translation is committed to providing scalable, quality-focused, technology-based language solutions.
As a resource, we’ve compiled a glossary of frequently used terms related to medical devices, regulatory affairs and accompanying documentation (listed in alphabetical order).
Clinical Evaluation Report (CER) – A document that analyzes and evaluates the clinical data pertaining to a medical device to verify its safety and performance when used as intended. CERs are vital for regulatory submission and compliance, particularly in the European Union.
Design History File (DHF) – A compilation of records that describes the design history of a finished medical device. It must contain or reference the records necessary to demonstrate that the device was designed and developed in accordance with the approved design plan and regulatory requirements.
Device Master Record (DMR) – A compilation of records containing the necessary information and specifications for manufacturing a medical device. This includes design specifications, manufacturing process specifications, quality assurance procedures, packaging and labeling specifications.
Directions for Use (DFU) / Instructions for Use (IFU) – The written information provided by the device manufacturer that informs the user about the device’s intended purpose, proper operation, safety warnings and maintenance. Accurate translation of these vital documents is non-negotiable for patient and user safety.
European Union Medical Device Regulation (EU MDR) – A set of regulations (Regulation 2017/745) governing the production and distribution of medical devices in the EU. It replaced the previous Medical Device Directive (MDD) and introduced stricter requirements for clinical evidence, quality assurance and post-market surveillance.
Good Manufacturing Practice (GMP) – A system of procedures and documentation ensuring that products, such as medical devices, are consistently produced and controlled according to quality standards. Adherence to GMP is a regulatory requirement in many markets, including the US and EU.
Labeling – All written, printed or graphic material appearing on the medical device, its container or its wrapper. Linguistic and cultural equivalence is essential for translated labeling to ensure user understanding and regulatory compliance across different markets.
Medical Device – An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, and does not achieve its primary intended purposes through chemical action within or on the body.
Post-Market Surveillance (PMS) – The systematic process of collecting and analyzing experience gained from devices that have been placed on the market. This includes monitoring device performance, identifying potential safety issues and ensuring ongoing compliance with regulatory requirements.
Quality Management System (QMS) – A formalized system that documents processes, procedures and responsibilities for achieving quality policies and objectives. For medical devices, QMS compliance with standards like ISO 13485 is often a prerequisite for market entry.
Risk Mitigation – The process of identifying, evaluating and taking steps to reduce or eliminate potential hazards associated with a medical device. This is a core part of the device lifecycle and relies on accurate documentation and communication across all languages.
Technical File / Design Dossier – A collection of documents that describes the device, its intended use, design, manufacturing and performance. This file is required by regulatory bodies, such as the EU and certain other global regions, to demonstrate that a device meets the applicable essential requirements.
Validation / Linguistic Validation – The process of testing a translated or culturally adapted document to confirm that it retains linguistic and cultural equivalence and measures the same concept in the target language as the original.
If our Glossary of Medical Device Terms has been helpful to you, we encourage you to share it with a colleague or let us know.