All MedTech Terms
513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–24 of 101
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Accreditation Scheme for Conformity Assessment(ASCA)
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
Additional Condition for Nonprescription Use(ACNU)
FDA framework for nonprescription drugs with approved additional conditions needed for appropriate self-selection or actual use when labeling alone is insufficient.
AI Act Conformity Assessment (Medical Devices)
For AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route.
AI Act Post-Market Monitoring
Ongoing, documented monitoring of a high-risk AI system's performance after it is placed on the market.
AI Act Prohibited Practices
Article 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping.
AI Act Serious Incident Reporting
Duty on providers of high-risk AI systems to report serious incidents to national market-surveillance authorities.
AI Act Technical Documentation (Annex IV)
The information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15.
AI Act Transparency Obligations
Article 50 requirements for specific AI systems, including disclosure that a user is interacting with AI and labelling of synthetic content.
Analytical Performance (IVDR)
The ability of an IVD to correctly detect or measure a particular analyte.
ANVISA(ANVISA)
Brazil's National Health Surveillance Agency, regulating medical devices and IVDs.
Authorized Representative (EU)(EC REP)
Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes.
Benefit-Risk Determination
Assessment weighing probable benefits against probable risks of a device.
Breakthrough Device Designation(BDD)
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
CE Mark
Mandatory European conformity mark for medical devices placed on the EU market.
Class D Batch Verification (IVDR)
Pre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated.
Class III Device
FDA's highest-risk device class, generally requiring PMA.
Clinical Evaluation Consultation Procedure(CECP)
MDR Article 54 procedure in which an independent expert panel reviews the notified body's clinical evaluation assessment for certain Class III and implantable Class IIb devices.
Clinical Performance (IVDR)
The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.
Combination Product
Product comprised of two or more regulated components - e.g., drug-device, biologic-device.
Common Specifications(CS)
Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.