--- title: "Regulated Pathways - MedTech Ecosystems" description: "Submission types, review pathways, and the regulators who run them - from 510(k) and PMA to CE marking under MDR and global routes through PMDA, NMPA, and MHRA." lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All ecosystems](/ecosystems) Ecosystem # Regulated Pathways Submission types, review pathways, and the regulators who run them - from 510(k) and PMA to CE marking under MDR and global routes through PMDA, NMPA, and MHRA. 114 terms ## Regulatory99 - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [513(g) Request for Information(513(g)) ](/terms/513g) - [Abbreviated 510(k) ](/terms/abbreviated-510k) - [Accreditation Scheme for Conformity Assessment(ASCA) ](/terms/asca) - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [AI Act Prohibited Practices ](/terms/ai-act-prohibited-practices) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations) - [Analytical Performance (IVDR) ](/terms/ivdr-analytical-performance) - [ANVISA(ANVISA) ](/terms/anvisa) - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) - [Benefit-Risk Determination ](/terms/benefit-risk) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [CE Mark ](/terms/ce-mark) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [Class III Device ](/terms/class-iii) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [Combination Product ](/terms/combination-product) - [Common Specifications(CS) ](/terms/common-specifications) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [Companion Diagnostic (IVDR)(CDx) ](/terms/ivdr-companion-diagnostic) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Device Master File(MAF) ](/terms/device-master-file) - [Device Reclassification Petition ](/terms/reclassification-petition) - [Electronic Instructions for Use(eIFU) ](/terms/eifu) - [Emergency Use Authorization(EUA) ](/terms/eua) - [eSTAR ](/terms/estar) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [EUDAMED ](/terms/eudamed) - [FDA Recognized Consensus Standards ](/terms/recognized-standards) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [General Controls ](/terms/general-controls) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [General-Purpose AI Model(GPAI) ](/terms/ai-act-gpai) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Health Canada Medical Device Licence(MDL) ](/terms/health-canada-mdl) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [Humanitarian Device Exemption(HDE) ](/terms/hde) - [IMDRF ](/terms/imdrf) - [Importer and Distributor Obligations (EU) ](/terms/importer-distributor) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Indications for Use(IFU (statement)) ](/terms/indications-for-use) - [Instructions for Use(IFU) ](/terms/ifu) - [Intended Use ](/terms/intended-use) - [ISO 20916 ](/terms/iso-20916) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [Labeling ](/terms/labeling) - [Letter to File(LTF) ](/terms/letter-to-file) - [MDR Article 117 ](/terms/mdr-article-117) - [Medical Device Coordination Group Guidance(MDCG) ](/terms/mdcg) - [Medical Device User Fee Amendments(MDUFA) ](/terms/mdufa) - [Metrological Traceability (IVDR) ](/terms/ivdr-metrological-traceability) - [MHRA / UKCA Marking(MHRA / UKCA) ](/terms/mhra-ukca) - [Ministry of Food and Drug Safety (Korea)(MFDS) ](/terms/mfds) - [Modular PMA ](/terms/pma-modular) - [National Medical Products Administration(NMPA) ](/terms/nmpa) - [NMPA Innovative Medical Device Pathway ](/terms/nmpa-innovation) - [Notified Body(NB) ](/terms/notified-body) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Pharmaceuticals and Medical Devices Agency(PMDA) ](/terms/pmda) - [PMA Supplement Types ](/terms/pma-supplement-types) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Predicate Device ](/terms/predicate-device) - [Premarket Approval(PMA) ](/terms/pma) - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Refuse to Accept(RTA) ](/terms/rta) - [Request for Designation(RFD) ](/terms/rfd) - [Safer Technologies Program(STeP) ](/terms/step) - [Saudi Food and Drug Authority(SFDA) ](/terms/sfda) - [Scientific Validity (IVDR) ](/terms/ivdr-scientific-validity) - [Self-Test and Near-Patient Testing (IVDR) ](/terms/ivdr-self-test) - [Special 510(k)(Special 510(k)) ](/terms/special-510k) - [Special Controls ](/terms/special-controls) - [Substantial Equivalence(SE) ](/terms/substantial-equivalence) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [Swissmedic ](/terms/swissmedic) - [Systemic Risk (GPAI) ](/terms/ai-act-systemic-risk) - [Therapeutic Goods Administration(TGA) ](/terms/tga) - [Third-Party Review of 510(k)(3P 510(k)) ](/terms/third-party-510k) - [UK Responsible Person(UKRP) ](/terms/ukrp) - [Unique Device Identification(UDI) ](/terms/udi) - [WHO Prequalification (Diagnostics)(WHO PQ Dx) ](/terms/who-pq-dx) ## Cybersecurity1 - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) ## Clinical & Trials4 - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Clinical Evaluation Report(CER) ](/terms/cer) - [Clinical Investigation Plan(CIP) ](/terms/cip) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) ## Manufacturing1 - [Pre-Approval Inspection(PAI) ](/terms/pai) ## Post-Market8 - [5-Day Report ](/terms/five-day-report) - [Annual Report (PMA) ](/terms/annual-report-pma) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) - [Periodic Safety Update Report(PSUR) ](/terms/psur) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [PSUR (IVDR Specific) ](/terms/psur-ivdr) - [Trend Reporting (MDR/MIR) ](/terms/trend-reporting) ## Reimbursement1 - [Transitional Coverage for Emerging Technologies(TCET) ](/terms/tcet) ### Other ecosystems [AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle)[Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)[Manufacturing & Supply](/ecosystems/manufacturing-supply) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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