Official Source Ledger

Research date: 2026-07-23 Method: targeted parallel-cli search and parallel-cli extract, restricted to official publishers and regulator/program sites. Purpose: version baseline for this skill; not legal advice, an applicability decision, certification criteria, or a substitute for controlled source copies.

Recheck every source before operational use. Web pages and consolidated texts can change after the research date.

ISO standards and copyright

ISO 13485:2016

• Official page: ISO 13485:2016
• Verified metadata: Edition 3; publication date 2016-03; stage 90.93 (confirmed); 2025 systematic review closed 2025-06-05 and confirmation recorded 2025-10-31.
• Use: identifies the current international edition and lifecycle status.
• Limitation: the ISO page is not the complete normative text. Obtain an authorized copy.

EN ISO 13485:2016/A11:2021 distinction

• Current Commission index: Harmonised standards
• Current MDR decision: Consolidated Decision (EU) 2021/1182, 2026-06-17
• IVDR amendment decision: Decision (EU) 2022/729
• Verified fact: current EU lists include EN ISO 13485:2016, AC:2018, and A11:2021. A11:2021 is a European EN amendment, not an ISO international “Amendment 1:2021.”
• Limitation: verify the latest OJEU citation and the exact requirements for which presumption of conformity is claimed; use of harmonised standards is not a blanket product-conformity decision.

ISO 14971:2019 and European A11

• Official page: ISO 14971:2019
• Verified metadata: Edition 3; publication 2019-12; reviewed and confirmed in 2025.
• EU source: Decision (EU) 2022/757
• Verified fact: EN ISO 14971:2019/A11:2021 is cited for MDR and, through the corresponding IVDR decision, IVDR support. A11 is European; it does not change the international ISO 14971 normative part.
• Limitation: risk-management evidence remains product- and jurisdiction-specific.

ISO copyright

• Official page: ISO copyright
• Verified fact: ISO publications are copyright protected; unauthorized copying, scanning, or distribution is prohibited, and reproduction requires permission.
• Operational rule: this skill summarizes processes and bibliographic metadata only. Do not paste or generate copyrighted clause text.

United States: FDA QMSR

Final rule

• Source: Medical Devices; Quality System Regulation Amendments
• Citation/date: 89 FR 7496; published 2024-02-02.
• Verified effective date: 2026-02-02.
• Verified boundary: ISO certification does not exempt a manufacturer from FDA inspection; FDA does not issue ISO 13485 certificates.
• Correction: 2024 correction.
• Later source: 2025 QMSR technical amendments. Use the current eCFR rather than reconstructing current requirements from the original final rule alone.

FDA QMSR landing page

• Source: Quality Management System Regulation (QMSR)
• Page update: 2026-02-02.
• Verified current state: QMSR became effective 2026-02-02; it incorporates ISO 13485:2016 and ISO 9000:2015 Clause 3 by reference, with FDA provisions and other applicable FDA requirements controlling as stated in the regulation.
• Verified inspection transition: FDA stopped using QSIT and began the inspection process in Compliance Program 7382.850 on 2026-02-02.

Current eCFR

• Source: 21 CFR Part 820
• Verified current title: Quality Management System Regulation.
• Verified current structure: Subpart A contains current general provisions; Subpart B contains supplemental provisions; remaining legacy subparts are reserved.
• Verified incorporation: ISO 13485:2016(E), Third edition, March 1, 2016, and ISO 9000:2015 Clause 3.
• Operational rule: use the current eCFR and linked current regulations. Do not use the former QSR section structure as a current requirements map.
• Limitation: eCFR is continuously updated and authoritative but unofficial; consult official CFR/Federal Register publications when legal status matters.

FDA QMSR FAQ

• Source: QMSR Frequently Asked Questions
• Page update: 2026-02-02.
• Verified implementation status: FDA began enforcing QMSR on the effective date.
• Verified records point: FDA investigators may review QMS records created before 2026-02-02. The former exemption for management-review, quality-audit, and supplier-audit reports was not retained.
• Verified boundary: FDA QMSR inspections do not follow the MDSAP audit plan; an ISO certificate does not replace or prevent FDA inspection.
• Verified access: FDA points to ANSI read-only IBR access for incorporated standards.

Current inspection program

• Source: Inspection of Medical Device Manufacturers Compliance Program 7382.850
• Effective date: 2026-02-02.
• Verified use: current FDA inspection process aligned to QMSR; QSIT and the superseded device inspection programs are no longer used.
• Supplemental education: April 2026 FDA town hall.
• Limitation: prepare evidence for actual applicable FDA requirements; this skill does not predict inspection scope, classification, or enforcement outcome.

MDSAP and IMDRF

Current MDSAP Audit Approach

• Source: MDSAP Audit Approach
• Current document: MDSAP AU P0002.010.
• Version date: 2026-02-02.
• Verified high-level model: process-based regulatory audit by recognized Auditing Organizations, with four primary process areas, supporting purchasing linkages, a risk-management foundation, jurisdiction-specific requirements, and a three-year audit cycle.
• Superseded baseline observed during research: FDA-hosted P0002.009 dated 2024-08-06. Use the current MDSAP.global library instead.

MDSAP program and IMDRF foundation

• Current program site: MDSAP.global
• IMDRF background: IMDRF MDSAP working group
• FDA program page: Medical Device Single Audit Program
• Verified status: IMDRF development work moved to implementation; current MDSAP documents are managed on MDSAP.global.
• Boundary: an MDSAP audit is not generic ISO certification, an FDA inspection plan, or EU notified-body conformity assessment.

European Union: MDR, IVDR, and MDCG

MDR

• Source: Regulation (EU) 2017/745, consolidated 2026-01-01
• Verified status as of research: consolidated version dated 2026-01-01.
• Relevant scope for this skill: manufacturer QMS, technical documentation, conformity assessment, notified bodies, postmarket surveillance, vigilance, and market surveillance.
• Limitation: consolidated texts are documentation tools; authentic acts are those published in the Official Journal.

IVDR

• Source: Regulation (EU) 2017/746, consolidated 2025-01-10
• Verified status as of research: 2025-01-10 was the current consolidated version.
• Relevant scope for this skill: IVD QMS, technical/performance documentation, conformity assessment, notified bodies, postmarket surveillance, vigilance, and market surveillance.
• Limitation: transitional provisions and device-specific deadlines require current, authorized analysis; this skill does not calculate them.

MDCG guidance

• Source: MDCG endorsed documents and other guidance
• Verified legal status: MDCG guidance is not legally binding; it expresses a common implementation understanding and is regularly revised or archived.
• Relevant current item: MDCG 2025-10, post-market surveillance, published December 2025.
• Other items must be selected by device, role, transition, and conformity route.

Notified bodies, certification, and accreditation

EU notified bodies

• Commission overview: Notified bodies for medical devices
• Official list: NANDO
• Verified boundary: Member States designate and notify bodies for defined legislation, conformity-assessment tasks, and product/designation codes. NANDO lists the current notified scope.
• Operational rule: verify legislation, annex/task, and designation-code scope. Accreditation or ISO certification alone is not notified-body designation.

ISO 13485 certification-body accreditation

• Current Global ACI documents: Global ACI document library
• Current cross-reference: Global ACI–IAF/ILAC table, version 1.2, 2026-06-10
• Carried document: IAF MD 9:2023 Issue 5
• Verified transition: Global Accreditation Cooperation Incorporated began full operations on 2026-01-01, replacing IAF/ILAC operational functions. The 2026-06-10 table showed successor Global ACI documents for former MD 8/MD 9 as in process while the prior documents remained in the current library.
• Verified boundary: MD 9 concerns bodies auditing/certifying management systems to ISO 13485 under ISO/IEC 17021-1. It does not establish product conformity, notified-body designation, regulatory applicability, or market authorization.

Research queries used

Parallel searches/extracts covered:

• ISO 13485 edition, review/confirmation, and amendment metadata;
• ISO versus EN A11:2021 distinction and current EU citations;
• FDA final rule, QMSR page/FAQ, eCFR Part 820, and Compliance Program 7382.850;
• current MDSAP/IMDRF program and Audit Approach version;
• current MDR/IVDR consolidated versions and MDCG guidance;
• ISO 14971 and EN A11 status;
• NANDO/notified-body designation boundaries; and
• the 2026 Global ACI transition and current MD 8/MD 9 documents.

No Parallel research JSON was saved in the repository.