Glossary of regulatory terms

Plain-language definitions of the terms and acronyms used across medical device registers.

21 CFR: Title 21 of the Code of Federal Regulations: The US regulations established by the FDA for medical devices and diagnostics.
510(k): A submission asking the FDA to agree that a new device is close enough to one already on the market.
Adverse Event: Any untoward medical occurrence or device failure associated with the use of a medical device.
Australian Sponsor: An Australian entity responsible for registering and importing foreign medical devices into Australia.
Authorised Representative: A representative located within the EU or target region appointed by an overseas manufacturer to handle regulatory obligations.
Basic UDI-DI: Basic Unique Device Identifier - Device Identifier: The primary key in EUDAMED connecting devices with the same purpose.
CE Mark: Conformité Européenne Mark: A symbol indicating that a medical device complies with European safety and performance standards.
Clinical Evaluation Report: A documented analysis of clinical data proving a device's safety, performance, and risk-benefit ratio.
CND Code: Classificazione Nazionale dei Dispositivi medici Code: An Italian system forming the structural basis of EMDN.
Competent Authority: A national government body authorized to enforce medical device legislation within its jurisdiction.
De Novo: A route for low- to moderate-risk devices with no existing product to compare against.
Device Class / Risk Class: The regulatory categorization of a medical device based on its risk to patients and users.
EMDN: European Medical Device Nomenclature: The official classification system used for registering medical devices in EUDAMED under EU regulations.
EU Person Responsible for Regulatory Compliance: PRRC: A designated individual within a device company responsible for ensuring EU regulatory compliance.
EUDAMED: European Database on Medical Devices: The European Commission's portal for medical devices placed on the EU market.
FDA: Food and Drug Administration: The US federal agency responsible for regulating medical devices, drugs, and food safety.
FDA Product code: Food and Drug Administration Product Code: A three-letter code assigned by the FDA to categorize device types.
Health Canada: The Canadian government department responsible for national public health and medical device regulation.
Intended Purpose: The specific use for which a medical device is designed according to the manufacturer's labeling and claims.
ISO 13485: International Organization for Standardization 13485: The internationally recognised quality standard for the medical device industry.
IVDR: In Vitro Diagnostic Regulation: The European Union regulatory framework governing the safety and performance of in vitro diagnostic medical devices.
K-Number: The unique identification number assigned by the FDA to a 510(k) premarket notification.
Licence Type (Health Canada): The specific regulatory authorization required by Health Canada based on a medical device's risk classification.
Manufacturer: The natural or legal person with ultimate responsibility for the design, manufacture, packaging, and labeling of a device.
MAUDE: Manufacturer and User Facility Device Experience: The FDA's searchable database of medical device adverse events.
MDR: Medical Device Regulation: The European Union framework governing the manufacturing, clinical evaluation, and sale of medical devices.
MDR vs MDD: Medical Device Regulation vs Medical Devices Directive: The transition to stricter EU medical device rules.
MHRA: Medicines and Healthcare products Regulatory Agency: The executive agency responsible for regulating medical devices in the UK.
Notified Body: An independent organisation designated by a national authority to assess the conformity of medical devices before market launch.
PARD: Public Access Registration Database: The MHRA's public database for medical devices registered in the UK.
PMA: Premarket Approval: The FDA's most demanding review pathway, used for the highest-risk devices.
Post-Market Surveillance: The proactive collection and analysis of real-world data on a device after it has been placed on the market.
Predicate: A legally marketed medical device used as a baseline comparison for a new device submission.
Predicate Chain: A lineage of 510(k) clearances where each device cited an earlier predicate device as its benchmark.
Predicate device: The legally marketed device that a 510(k) submission compares itself against.
Primary DI: Primary Device Identifier: The unique code on a medical device label identifying the specific model and packaging level.
PubMed: Public/Publisher MEDLINE: A free search engine accessing biomedical literature and research database references.
Q-Submission: Quality Submission: A voluntary process for obtaining early feedback from the FDA regarding medical device development plans.
QMS: Quality Management System: An organised framework of policies and processes designed to ensure devices meet safety standards.
Recall: An action taken to address a problem with a medical device that violates law or poses a health risk.
SaMD: Software as a Medical Device: Software intended to be used for medical purposes without being part of a hardware medical device.
Single Use: A designation for a medical device intended to be used on a single patient during a single procedure.
SRN: Single Registration Number: A unique identifier assigned in EUDAMED to economic operators in the EU medical device market.
TGA: Therapeutic Goods Administration: Australia's regulatory authority for therapeutic goods, including medical devices and IVDs.
UDI: Unique Device Identifier: A standard code that identifies a specific device model and the batch it came from.
UK Responsible Person: The legal entity designated by a foreign manufacturer to act on its behalf in the United Kingdom.