QARA glossary: 60 essential acronyms explained

The daily life of a QA/RA professional is saturated with acronyms — some from European law, others from the FDA, others still from ISO standards. This glossary brings together the 60 most frequent acronyms, sorted by category and clearly explained.

European regulatory frameworks

MDR — Medical Device Regulation. Regulation (EU) 2017/745 on medical devices, applicable since 26 May 2021. Replaces Directives 90/385/EEC and 93/42/EEC.

IVDR — In Vitro Diagnostic Regulation. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, applicable since 26 May 2022. Replaces Directive 98/79/EC.

IVD — In Vitro Diagnostic medical device. In French: DMDIV.

MDD — Medical Device Directive. Directive 93/42/EEC, the former European framework for medical devices, still applicable for devices in transition until end 2027/2028.

AIMDD — Active Implantable Medical Device Directive. Directive 90/385/EEC, the former framework for active implantable devices.

MDCG — Medical Device Coordination Group. Member State coordination group that publishes interpretative guidance (MDCG 2019-XX, 2020-XX, etc.) for the uniform application of the MDR/IVDR.

EUDAMED — European Database on Medical Devices. Single European database for registering devices, economic operators, certificates, vigilance incidents and clinical investigations.

Economic operators and bodies

PRRC — Person Responsible for Regulatory Compliance. Person responsible for ensuring regulatory compliance, designated by the manufacturer or authorised representative (Article 15 MDR/IVDR).

NB — Notified Body. Body designated by a Member State to assess a device's conformity.

EURL — European Reference Laboratory. European reference laboratory for IVDR class D devices — batch testing verification before placing on the market.

ANSM — Agence Nationale de Sécurité du Médicament et des produits de santé. The French competent authority for medical devices and medicinal products.

EMA — European Medicines Agency. The European medicines agency, in Amsterdam. Competent for medicinal products, but also for combination devices and IVD companion diagnostics.

FDA — Food and Drug Administration. The US agency regulating medical devices, medicines and food.

CDRH — Center for Devices and Radiological Health. The FDA branch dedicated to medical devices.

MHRA — Medicines and Healthcare products Regulatory Agency. The UK post-Brexit authority (UKCA system).

Documentation and conformity

TD — Technical Documentation. Complete file of conformity evidence, structure defined by Annexes II and III of the MDR/IVDR.

DoC — Declaration of Conformity. EU declaration of conformity (Annex IV MDR/IVDR), signed by the manufacturer.

CE — Conformité Européenne. Marking attesting a device's conformity with the MDR or IVDR.

UDI — Unique Device Identification. Unique device identification system in two components: UDI-DI (device identifier) and UDI-PI (production identifier).

SRN — Single Registration Number. Unique identifier assigned by EUDAMED to each economic operator (manufacturer, authorised representative, importer).

SSCP — Summary of Safety and Clinical Performance. Public summary of safety and clinical performance characteristics for implantable and class III devices under the MDR.

SSP — Summary of Safety and Performance. SSCP equivalent for classes C and D under the IVDR.

Clinical and performance evaluation

CER — Clinical Evaluation Report. Clinical evaluation report under the MDR, demonstrating the device's clinical benefits and benefit/risk profile.

CEP — Clinical Evaluation Plan. Clinical evaluation plan that structures the approach.

PER — Performance Evaluation Report. Performance evaluation report under the IVDR (scientific validity, analytical performance, clinical performance).

PMCF — Post-Market Clinical Follow-up. Clinical follow-up after commercialisation, an MDR requirement.

PMPF — Post-Market Performance Follow-up. Performance follow-up after commercialisation, the IVDR equivalent of PMCF.

IFU — Instructions for Use. The device's instructions for use.

Post-market surveillance

PMS — Post-Market Surveillance. Post-market surveillance, a structured manufacturer approach to collecting and analyzing field data.

PMSR — Post-Market Surveillance Report. Surveillance report for class I devices and IVDR classes A/B.

PSUR — Periodic Safety Update Report. Periodic safety update report, mandatory for classes IIa, IIb, III under the MDR and C, D under the IVDR.

FSCA — Field Safety Corrective Action. Field safety corrective action (recall, update, communication).

FSN — Field Safety Notice. Safety notice accompanying an FSCA.

SAE — Serious Adverse Event. Serious adverse event (death, serious deterioration in health, serious threat).

Quality management system

QMS — Quality Management System.

ISO 13485 — The international reference standard for medical device manufacturers' QMS. Current version: ISO 13485:2016.

CAPA — Corrective and Preventive Action. Corrective and preventive actions — the cornerstone of continual QMS improvement.

NC — Nonconformity. A deviation from specified requirements.

SOP — Standard Operating Procedure.

WI — Work Instruction. Detailed work instruction.

Risk management and human factors

ISO 14971 — International standard on the application of risk management to medical devices. Current version: ISO 14971:2019.

RMF — Risk Management File.

FMEA — Failure Mode and Effects Analysis. A classic risk assessment method.

HFE — Human Factors Engineering, framed by EN 62366-1 and IEC 62366.

UE — Use Error.

International markets

MDSAP — Medical Device Single Audit Program. Single audit programme giving simultaneous access to the United States, Canada, Brazil, Australia and Japan markets. Also recognised by the EU and the United Kingdom in certain cases.

510(k) — Premarket notification procedure in the United States for class I and II devices equivalent to an already marketed device.

PMA — Premarket Approval. FDA authorisation procedure for class III devices in the United States.

De Novo — FDA procedure for innovative devices with no equivalent predicate.

QSR / 21 CFR Part 820 — Quality System Regulation. The FDA quality framework, currently being replaced by alignment with ISO 13485 (Quality Management System Regulation, QMSR).

UKCA — UK Conformity Assessed. The British post-Brexit marking (transition extended to 2030).

TGA — Therapeutic Goods Administration. The Australian authority.

PMDA — Pharmaceuticals and Medical Devices Agency. The Japanese authority.

ANVISA — Agência Nacional de Vigilância Sanitária. The Brazilian authority.

Norms and standards

IEC 60601 — Family of standards on the electrical safety of medical devices.

ISO 10993 — Family of standards on the biological evaluation of medical devices (biocompatibility).

ISO 11135 / 11137 — Sterilisation by ethylene oxide and by radiation.

IEC 62304 — Software embedded in medical devices.

IEC 82304 — Software as a medical device (SaMD).

Other useful acronyms

SaMD — Software as a Medical Device.

SiMD — Software in a Medical Device.

IMDRF — International Medical Device Regulators Forum. International regulators' forum which harmonises approaches (United States, EU, Japan, Canada, etc.).

AI Act — Regulation (EU) 2024/1689 on artificial intelligence. Covers high-risk AI systems, including certain medical devices incorporating AI.

GDPR — General Data Protection Regulation. Regulation (EU) 2016/679 on the protection of personal data, applicable to medical devices processing health data.

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