2026-09-21 · KeXinMaterials 编辑团队

FDA 21 CFR Part 820 + ISO 13485 + EU MDR/IVDR 医疗器械监管家族保护箱 B2B 指南

FDA 21 CFR Part 820 (QSR, 2026 转为 QMSR) + ISO 13485:2016 + EU MDR 2017/745 + EU IVDR 2017/746 是四大医疗器械监管框架。医疗器械 + IVD 必备。

FDA 21 CFR Part 820 Quality System Regulation (QSR) + QMSR 2026

FDA 21 CFR Part 820 (Quality System Regulation, QSR) establishes QMS requirements for medical device manufacturers marketing in US. FDA QMSR (Quality Management System Regulation) effective 2026 replaces Part 820 + aligns with ISO 13485:2016.

FDA 21 CFR Part 820: "Quality System Regulation" for medical device manufacturers. Final Rule 1996. Applicable to all finished medical devices manufactured in US or imported.

Part 820 scope: Design + production + distribution + post-market for medical devices (Class I + II + III). Includes design controls (Class II + III) + production controls + CAPA + management responsibility.

Part 820 subparts: A General Provisions (820.1-820.5). B Quality System Requirements (820.20-820.25). C Design Controls (820.30-820.46). D Document Controls (820.40-820.45). E Purchasing Controls (820.50). F Identification + Traceability (820.60-820.86). G Production + Process Controls (820.70-820.100). H Acceptance Activities (820.80-820.86). I Nonconforming Product (820.90-820.100). J Corrective + Preventive Action (820.100). K Labeling + Packaging (820.120-820.130). L Handling + Storage + Distribution (820.140-820.160). M Records (820.180-820.198). N Servicing (820.200). O Statistical Techniques (820.250).

Part 820 design controls: Design + development + design input + design output + design review + design verification + design validation + design transfer + design changes + design history file (DHF). Applicable to Class II + III.

Part 820 CAPA: Corrective + Preventive Action (820.100). Identification + investigation + root cause analysis + corrective action + preventive action + verification of effectiveness + documentation.

Part 820 management review: Top management review of QMS at planned intervals (820.20(c)).

FDA QMSR 2026: "Quality Management System Regulation" (effective February 2, 2026, after 1-year transition + 1-year compliance extension to February 2, 2027). Replaces 21 CFR Part 820.

QMSR vs ISO 13485:2016: QMSR incorporates ISO 13485:2016 by reference + adds US-specific requirements (unique device identification UDI + post-market surveillance + labeling + corrections + removals + MDR reporting + recall + electronic records).

FDA 510(k) + De Novo + PMA: Premarket notification (510(k) for Class II + substantial equivalence) + De Novo classification (novel + low-moderate risk) + PMA (premarket approval for Class III high-risk).

FDA inspection: FDA Center for Devices and Radiological Health (CDRH) inspects medical device manufacturers per QSIT (Quality System Inspection Technique). Form 483 + Warning Letter + Import Alert + seizure.

Geographic scope: US FDA jurisdiction. Mutual Recognition Agreements (MRAs) with EU + Switzerland + Canada + Australia + Japan + Brazil + Mexico + Singapore + others for inspection exchange.

B2B relevance: For B2B protective cases containing medical device components + finished medical devices, FDA 21 CFR Part 820 / QMSR compliance required for US market entry.

ISO 13485:2016 Medical Device QMS

ISO 13485:2016 "Medical devices - Quality management systems - Requirements for regulatory purposes". Edition 3 (2016). Replaces ISO 13485:2003 + ISO 13485:2003/Cor 1:2009.

ISO 13485:2016: "Medical devices - Quality management systems - Requirements for regulatory purposes". Edition 3 (2016). Replaces ISO 13485:2003.

ISO 13485 scope: QMS requirements for medical device manufacturers + design + production + installation + servicing. Regulatory purpose (not full QMS per ISO 9001).

ISO 13485 structure: Clauses 4-8 (QMS + management responsibility + resource management + product realization + measurement + analysis + improvement).

Clause 4 QMS: Quality manual + medical device file + control of documents + control of records.

Clause 5 Management responsibility: Management commitment + customer focus + quality policy + planning + responsibility + authority + communication + management review.

Clause 6 Resource management: Human resources + infrastructure + work environment + contamination control.

Clause 7 Product realization: Planning + customer-related processes + design + development (input + output + review + verification + validation + transfer + changes + DMR) + purchasing + production + service provision + monitoring + measuring.

Clause 8 Measurement + analysis + improvement: Monitoring + measurement (feedback + complaint handling + reporting to regulatory authorities) + internal audit + control of nonconforming product + analysis of data + improvement (CAPA).

ISO 13485 vs ISO 9001:2015: ISO 13485 is medical-device specific + regulatory purpose. ISO 9001 is generic QMS. ISO 13485 retains 2008-era ISO 9001 structure (no high-level structure Annex SL). ISO 13485 includes risk management + regulatory focus + design controls + post-market.

ISO 13485 + ISO 14971: Risk management for medical devices (ISO 14971:2019). Integrated with ISO 13485 design + development + risk-based approach.

ISO 13485 certification: Issued by accredited certification bodies (BSI + TUV SUD + TUV NORD + DEKRA + Intertek + SGS + LRQA). Certificate valid 3 years with annual surveillance.

Geographic adoption: Adopted as EN ISO 13485:2016 (EU) + ANSI/AAMI/ISO 13485:2016 (US) + GB/T 19001/ISO 13485 (China) + JIS Q 13485 (Japan) + AS ISO 13485 (Australia) + others. Required for medical device manufacturers globally.

B2B relevance: ISO 13485:2016 certification is global baseline for medical device manufacturer QMS. Demonstrates regulatory compliance for B2B customers + FDA QMSR (incorporates by reference) + EU MDR/IVDR.

EU MDR 2017/745 + EU IVDR 2017/746

EU MDR (Medical Device Regulation, EU 2017/745) replaced MDD 93/42/EEC + AIMD 90/385/EEC + Active Implantable. EU IVDR (In Vitro Diagnostic Regulation, EU 2017/746) replaced IVDD 98/79/EC.

EU MDR Regulation (EU) 2017/745: "Medical Device Regulation". Published May 2017 + applied from May 26, 2021. Replaces MDD 93/42/EEC + AIMD 90/385/EEC.

EU MDR scope: Medical devices + active implantable medical devices. Excludes in vitro diagnostic (covered by IVDR) + medicinal products + cosmetic + food.

EU MDR Annex VIII classification: Class I (low risk) + Class IIa (low-medium risk) + Class IIb (medium-high risk) + Class III (high risk). Replaces MDD Class I + IIa + IIb + III.

EU MDR conformity assessment (Annex IX-XI): Class I (self-declaration + technical documentation). Class IIa (Notified Body + Annex IX or X). Class IIb (Notified Body + Annex IX or X). Class III (Notified Body + Annex IX + design dossier).

EU MDR technical documentation (Annex II + III): Required for all medical devices. Includes device description + intended purpose + classification + materials + design + manufacturing + risk management + verification + validation + clinical evaluation + post-market.

EU MDR clinical evaluation (Article 5 + Annex XIV): Required for all medical devices (except custom-made). Clinical investigation + clinical data + clinical evaluation report + PMCF (Post-Market Clinical Follow-up).

EU MDR unique device identification (UDI): Per Article 27 + Annex VI. UDI-DI (device identifier) + UDI-PI (production identifier). EUDAMED database.

EU MDR EUDAMED database: Article 33. Mandatory registration. Actor registration + UDI registration + certificates + clinical investigation + vigilance + post-market surveillance.

EU MDR post-market surveillance (Article 53-55): PMS plan + PMS report (Class I) + Periodic Safety Update Report PSUR (Class IIa + IIb + III). PSUR submitted to Notified Body annually (Class IIa) + at least annually (Class IIb + III).

EU MDR vigilance + serious incidents (Article 87-92): Serious incident reporting within 15 days + field safety corrective action + field safety notice + trend reporting + recall.

EU MDR authorised representative (Article 11): Non-EU manufacturers must appoint EU authorised representative based in EU. Responsible for compliance + registration + vigilance.

EU MDR person responsible for regulatory compliance (Article 15): Required for manufacturers + authorised representatives + importers. Qualifications: 1+ years regulatory + ISO 13485 knowledge + medical device regulatory knowledge.

EU MDR transition period: MDD certificates valid until May 2024 (Class I), May 2027 (Class IIa + IIb), May 2028 (Class III). Devices placed on market under MDD may continue to be made available until May 2025.

EU IVDR Regulation (EU) 2017/746: "In Vitro Diagnostic Medical Device Regulation". Published May 2017 + applied from May 26, 2022. Replaces IVDD 98/79/EC.

EU IVDR scope: In vitro diagnostic medical devices (IVDs). Tests + reagents + instruments + software + accessories.

EU IVDR Annex VIII classification: Class A (low risk) + Class B (moderate risk) + Class C (high risk) + Class D (high risk + transmissible agents). More risk-based than IVDD list-based.

EU IVDR conformity assessment (Annex IX-XI): Class A (self-declaration). Class B + C (Notified Body + Annex IX or X). Class D (Notified Body + batch testing for high-risk).

EU IVDR EU reference laboratory (EURL): For Class D devices (HIV + HBV + HCV + SARS-CoV-2 etc.). EURL batch testing + verification.

EU IVDR transition period: IVDD certificates valid until May 2025 (Class D), May 2026 (Class C), May 2027 (Class B), May 2027 (Class A self-declaration under IVDD). Devices placed on market under IVDD may continue until May 2025 (Class D), May 2026 (Class C), May 2027 (Class B).

B2B relevance: For B2B protective cases containing medical device components + IVD devices + sterile packaging, EU MDR + EU IVDR compliance + Notified Body certification + EUDAMED registration + authorised representative required for EU market entry.

Combined Medical Device Family + B2B Procurement + Case Correlation

Combined application of FDA 21 CFR Part 820 / QMSR + ISO 13485:2016 + EU MDR 2017/745 + EU IVDR 2017/746 + B2B procurement workflow.

Combined medical device family: FDA 21 CFR Part 820 (US QSR) / QMSR 2026 (US QMSR) + ISO 13485:2016 (international QMS) + EU MDR (EU medical device) + EU IVDR (EU IVD).

QMS harmonization: FDA QMSR (effective February 2026) incorporates ISO 13485:2016 by reference + adds US-specific requirements. ISO 13485:2016 required for EU MDR + EU IVDR conformity assessment.

Risk management per ISO 14971:2019: Required for FDA + EU + ISO 13485. Hazard identification + risk estimation + risk evaluation + risk control + residual risk + risk management report.

Biocompatibility per ISO 10993 (containers): Case materials contacting medical device must pass biocompatibility testing (cytotoxicity + sensitization + irritation + acute systemic toxicity).

Sterilization per ISO 11135 (EO) + ISO 11137 (radiation) + ISO 17665 (steam): Case + medical device sterilization validation. Required for sterile medical devices.

Packaging per ISO 11607: Packaging for terminally sterilized medical devices. Seal integrity + packaging validation + shelf life testing.

Transport testing per ASTM D4169 (shipping containers): Case shipping container performance testing (vibration + drop + compression + impact).

CE marking + EU DoC: Per Regulation (EU) 765/2008 + Decision 768/2008/EC + EU MDR Annex XII. CE mark affixed to medical device or sterile packaging. EU Declaration of Conformity (EU DoC).

US FDA establishment registration + device listing: Required per 21 CFR Part 807. Annual registration + device listing + 510(k) clearance + De Novo + PMA approval.

MDSAP (Medical Device Single Audit Program): Single audit covers ISO 13485:2016 + FDA 21 CFR 820/QMSR + Health Canada + Japan PMDA + Australia TGA + Brazil ANVISA. MDSAP accepted by participating authorities.

Common B2B mistakes: (1) Treating FDA Part 820 + ISO 13485 + EU MDR + IVDR as separate. (2) Missing FDA QMSR transition (Feb 2026). (3) Missing EU MDR transition (May 2024-2028). (4) Missing IVDR transition (May 2025-2027). (5) Not appointing EU authorised representative for non-EU manufacturer. (6) Missing EUDAMED registration. (7) Missing ISO 14971 risk management + ISO 10993 biocompatibility + ISO 11607 packaging.

B2B procurement workflow: (1) Identify customer medical device class (Class I + IIa + IIb + III + IVD Class A + B + C + D). (2) Verify supplier ISO 13485:2016 certification + MDSAP. (3) Verify FDA 21 CFR Part 820 + QMSR (US) + EU MDR + IVDR + UK MHRA + Japan PMDA + China NMPA compliance per market. (4) Verify ISO 14971 risk management + ISO 10993 biocompatibility + ISO 11607 packaging + ASTM D4169 transport testing. (5) Contract terms: CE marking + EU DoC + FDA 510(k) clearance + EUDAMED registration + authorised representative + vigilance reporting + recall.

B2B recommendation: For B2B protective cases for medical devices (Class I-IV) + IVD (Class A-D), require ISO 13485:2016 certification + MDSAP + FDA 21 CFR Part 820/QMSR + EU MDR/IVDR compliance + ISO 14971 risk management + ISO 10993 biocompatibility + ISO 11607 packaging + ASTM D4169 transport + CE marking + EU DoC + EUDAMED + authorised representative + FOB Shenzhen/Ningbo/EXW delivery 30-45 days.

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