Regulatory reference
Glossary of regulatory affairs
The acronyms and terms used every day in medical device and health product registration and quality, explained clearly.
25 terms
5
- 510(k)Premarket NotificationFDA
- An FDA submission pathway for moderate-risk devices demonstrating substantial equivalence to a product already legally marketed in the United States.
A
- ANVISABrazilian Health Regulatory AgencyANVISA
- The Brazilian regulatory authority responsible for registration, inspection and sanitary control of medical devices, medicines and other health products in Brazil.
B
- BEPBiological Evaluation PlanQuality
- A biological evaluation plan defining the material characterisation strategy and tests needed to demonstrate a device's biocompatibility under ISO 10993.
C
- CAPACorrective and Preventive ActionQuality
- A quality management system process that investigates the root cause of nonconformities and implements corrective and preventive actions to avoid recurrence.
- CERClinical Evaluation ReportEurope
- A clinical evaluation report bringing together and analysing the clinical evidence supporting a medical device's safety and performance, required under the EU MDR.
D
- De NovoDe Novo Classification RequestFDA
- An FDA regulatory pathway for novel low-to-moderate-risk devices without a legally marketed comparator, creating a new classification.
- DHFDesign History FileQuality
- A collection of records documenting a device's design and development history, demonstrating that the design followed the approved plan.
F
- FDAU.S. Food and Drug AdministrationFDA
- The United States regulatory agency responsible for authorising and supervising medical devices, medicines and other health products in the US market.
G
- GUDIDGlobal UDI DatabaseFDA
- The FDA database holding unique device identification (UDI) information for each medical device marketed in the United States.
I
- IVDIn Vitro DiagnosticGeneral
- An in vitro diagnostic device used to examine biological samples outside the human body (blood, tissues), with its own regulatory classification.
- IVDRIn Vitro Diagnostic Regulation (EU 2017/746)Europe
- The European regulation governing in vitro diagnostic devices in the European Union, replacing the former IVDD directive.
- ISO 10993Biological Evaluation of Medical DevicesISO/IEC
- A family of standards establishing principles and tests for the biological evaluation (biocompatibility) of medical devices in contact with the body.
- ISO 13485Quality Management Systems, Medical DevicesISO/IEC
- The international standard defining quality management system requirements specific to manufacturers and service providers in the medical device supply chain.
- ISO 14155Clinical Investigation of Medical DevicesISO/IEC
- The international good clinical practice standard for conducting clinical investigations of medical devices involving human subjects.
- ISO 14971Risk Management for Medical DevicesISO/IEC
- The international standard defining the risk management process throughout the medical device lifecycle, from initial design to post-market activities.
M
- MDRMedical Device Regulation (EU 2017/745)Europe
- The European regulation governing the placing of medical devices on the European Union market, forming the basis of CE marking for these products.
- MDSAPMedical Device Single Audit ProgramQuality
- A single-audit programme recognised by regulators in Brazil, the United States, Canada, Japan and Australia, in which one audit addresses the five markets.
N
- NCNonconformityQuality
- A deviation from a normative, regulatory or quality management system requirement, identified during audits, inspections or process monitoring.
P
- PMAPremarket ApprovalFDA
- The FDA's most rigorous regulatory pathway, applied to high-risk devices (Class III), requiring robust clinical evidence of safety and efficacy.
Q
- QSR / QMSRQuality System Regulation / Quality Management System RegulationFDA
- The FDA quality system regulation (21 CFR Part 820). The QMSR updates the former QSR by aligning it with ISO 13485.
R
- RDCCollegiate Board ResolutionANVISA
- An ANVISA regulatory instrument establishing rules and requirements, such as the RDCs applicable to medical device registration and good manufacturing practices.
S
- SaMDSoftware as a Medical DeviceGeneral
- Software intended for a medical purpose that operates independently, without being part of physical equipment, and is regulated as a medical device.
- STED / CSDTSummary Technical Documentation / Common Submission Dossier TemplateGeneral
- Standardised technical documentation formats used to organise medical device submission dossiers across different jurisdictions.
U
- UDIUnique Device IdentifierGeneral
- A unique identification system assigning a standardised code to each medical device, enabling traceability throughout the supply chain and after market entry.
- US AgentUnited States AgentFDA
- A representative required by the FDA for foreign manufacturers, serving as the point of contact between the company and the agency in the United States.
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