A. Quality Management System Alignment

✔ Confirm transition from QSR (1996) to QMSR (2026) across all internal documentation.
✔ Update your Quality Manual to reflect ISO 13485:2016 requirements.
✔ Verify the use of ISO 9000:2015 Clause 3 for terminology.
✔ Perform a QMS gap analysis comparing your current system to ISO 13485.
✔ Ensure all risk-based processes (design, manufacturing, supplier control, PMS) align with ISO 13485 and FDA expectations.

 

B. Documentation & Process Updates

✔ Map all QMS elements directly to ISO 13485 clauses (as recommended in FDA draft guidance).
✔ Update procedures for:

• Document control
• Design controls
• Risk management
• CAPA
• Complaint handling
• Supplier management
  ✔ Ensure your Device Master Records (DMR) and Design History Files (DHF) reflect ISO structure.

 

C. FDA Submission Requirements (PMA/HDE)

✔ Confirm DUNS numbers for all manufacturing, packaging, and sterilization sites.
✔ Prepare or update your UDI assignment & maintenance plan.
✔ Check labeling and regulatory submissions for consistency with ISO 13485 processes.
✔ Prepare a cross-table showing where FDA-required elements are addressed in ISO-aligned procedures.

 

D. Internal and Supplier Audits

✔ Schedule an ISO 13485–aligned internal audit before February 2026.
✔ Verify suppliers’ compliance with ISO 13485 or equivalent requirements.
✔ Document evidence of supplier risk assessments and ongoing monitoring.

 

E. Training & Change Management

✔ Train management and staff on the new QMSR terminology and expectations.
✔ Update competency matrices and training records.
✔ Communicate the QMSR effective date: 2 February 2026.

 

F. Post-Market Activities

✔ Align complaint handling, vigilance, and PMS with:

• ISO 13485
• FDA reporting requirements
  ✔ Ensure traceability aligns with UDI and ISO 13485 Clause 7.5.9.2.
  ✔ Confirm that PMS data feeds into management review and CAPA.

 

G. Management Review

✔ Add QMSR transition as a standing agenda item.
✔ Review:

• Gap analysis outcomes
• Audit results
• UDI readiness
• Supplier compliance
• PMS and CAPA trends
  ✔ Approve update actions and allocate resources.

 

H. Final Readiness Before 2 February 2026

✔ Validate that all updated procedures are approved, implemented, and communicated.
✔ Replace QSR terminology in documents with QMSR/ISO-based terms.
✔ Ensure that all submission-relevant information (UDI plan, DUNS numbers, mapping tables) is ready for FDA inspections.
✔ Maintain validation records for software, equipment, and critical processes according to ISO 13485.

 

 

 

 

 

The US Food and Drug Administration (FDA) is entering the final phase of one of the most significant regulatory transitions for medical devices in decades. After years of discussion, public consultation, and alignment efforts, the FDA has confirmed that its long-standing Quality System Regulation (QSR) will be replaced by the Quality Management System Regulation (QMSR). This shift formally harmonizes US quality requirements with ISO 13485:2016, the global cornerstone standard for medical device quality management.

For many manufacturers—particularly those active in global markets—this transition is not a surprise. The industry has been anticipating this move for several years, and many organizations have already begun aligning their quality systems with ISO 13485. At QNET, we support numerous clients worldwide in adopting or strengthening ISO 13485-based quality systems, including United Sports Brands (USB), whose QMS is already structured in accordance with ISO 13485:2016.

With QMSR, international alignment will increase, regulatory overlap will decrease, and manufacturers will benefit from a more consistent and predictable global compliance pathway.

 

Background: From QSR to QMSR

1. QSR Origins (1996)

Since 1996, US medical device manufacturers have been required to comply with 21 CFR Part 820, commonly known as the Quality System Regulation.

The regulation established Good Manufacturing Practice (GMP) requirements to ensure safety and effectiveness during design, production, packaging, labeling, storage, and servicing.

 

2. FDA Publishes the Final Rule (2024)

On 2 February 2024, the FDA published the final rule titled “Medical Devices; Quality System Regulation Amendments” in the Federal Register.

The rule implements two major changes:

• Renaming QSR → QMSR (Quality Management System Regulation)
• Harmonization with international QMS requirements, specifically ISO 13485:2016

Through incorporation by reference, the FDA formally adopts:

• ISO 13485:2016 – Quality management systems for medical devices
• ISO 9000:2015, Clause 3 – Terms and definitions

 

3. FDA Draft Guidance on Submissions (2025)

On 27 October 2025, the FDA released draft guidance describing the QMS-related information expected in new submissions, including:

• DUNS numbers for all manufacturing sites
• A UDI assignment and maintenance plan
• A clear mapping of QMS processes to ISO 13485 clauses
• Clarified expectations for PMA and HDE submissions under QMSR

This draft marks a shift away from the US-centric legacy QSR approach toward a globally harmonized, risk-based framework.

 

4. Effective Date

The QMSR becomes fully effective on 2 February 2026, replacing the existing QSR through amendments to 21 CFR Part 820. From that date onward, ISO 13485 compliance is no longer only “helpful”—it becomes the foundational requirement for all US medical device manufacturers.

 

What This Means for Manufacturers

Global Alignment and Reduced Regulatory Burden

With ISO 13485 at the core of US quality requirements, manufacturers operating in Europe, the UK, Switzerland, and other ISO-aligned markets will benefit from streamlined compliance and less duplication.

 

More Predictable Inspections

FDA investigators will evaluate quality systems using ISO-aligned terminology and structure. Organizations already operating under ISO 13485 will recognize most requirements, though the FDA retains certain US-specific expectations, including complaint handling, CAPA, and reporting obligations.

 

Updated Submission Requirements

Risk management, UDI strategy, and organizational traceability (including DUNS number accuracy) will now be integral parts of PMA and HDE submissions.

 

Stronger Emphasis on Risk-Based Processes

Like ISO 13485, QMSR reinforces a lifecycle approach, integrating risk management into design, manufacturing, and post-market activities.

 

How QNET Supports Clients During the QMSR Transition

QNET is already working with manufacturers preparing for the February 2026 enforcement date. Our support includes:

• Gap assessments between existing QSR-based systems and ISO 13485:2016
• Implementation or upgrading of ISO 13485-aligned QMS structures
• Documentation mapping for FDA submissions under the draft guidance
• PMS, vigilance, and UDI strategy development
• Internal audits conforming to ISO 13485, FDA expectations, and global AR/UKRP/CH-REP requirements

Because QNET operates across the EU, UK, Switzerland, and the US, clients benefit from unified guidance that addresses both US and international regulatory expectations.

 

Conclusion

The FDA’s shift from QSR to QMSR marks a historic milestone in international regulatory alignment. With ISO 13485 at the center of the new rule, manufacturers will face a more consistent global framework—one that supports quality, innovation, and patient safety. Organizations that have already adopted ISO 13485 are well-positioned for the transition, while others will need to begin preparing now to meet the February 2026 deadline.

 

QNET will continue to follow developments closely and provide further updates and practical guidance to our clients in the coming months.

 ISO has completed the 2025 systematic review of ISO 13485:2016 and confirmed the current edition. In practice, that means there is no new version and no adoption of the Annex SL / High-Level Structure at this time.

Why this matters

• Manufacturers and suppliers can continue using existing ISO 13485:2016-based QMS without re-structuring to Annex SL.
• Alignment efforts with regulators (e.g., FDA QMSR’s incorporation of ISO 13485) remain unaffected.
• If ISO decides to revise ISO 13485 in future cycles, Annex SL could resurface; for now, the 2016 edition remains current.

 

What manufacturers should do now

1. Continue operating under ISO 13485:2016 — no changes to your QMS structure or documentation are required.
2. Monitor regulatory alignment — the FDA’s Quality Management System Regulation (QMSR) and MDR/IVDR expectations remain based on the 2016 version.
3. Verify certificate validity — certification bodies will maintain current ISO 13485:2016 certificates; ensure your audit cycle remains on track.
4. Stay informed — watch for official announcements from ISO/TC 210 and your national standards body regarding any future revision plans.
5. Communicate with your supply chain — confirm suppliers and subcontractors are aware that no revision or Annex SL restructuring applies.

Sources: ISO catalogue (status “confirmed in 2025”); ISO/TC 210 background on possible HLS adoption if revised; national member communications on the 2025 review; industry updates from TC 210 participants.

Disclaimer
This article is intended for informational purposes only and reflects QNET’s interpretation of publicly available information from ISO and national standards bodies as of November 2025. ISO 13485 remains under the ownership and control of the International Organization for Standardization (ISO). Users should always consult the official ISO catalogue and their certification body for authoritative updates or requirements.

QNET Newsletter – October 2025

 

Introduction

Rules for placing medical devices, IVDs, and other regulated products on the market are changing fast. New EU regulations, adjustments in the UK and Switzerland, and global initiatives such as IMDRF and MDSAP are reshaping how manufacturers can sell their products worldwide.

This newsletter highlights the most relevant updates to help you understand what is happening, why it matters, and how QNET can support you as your EU Authorized Representative (EAR), UK Responsible Person (UKRP), Swiss Representative (CH-REP), and US Agent.

 

EU – Broader Responsibilities under the GPSR

Until now, appointing an EU Authorized Representative (EAR) was primarily a requirement for CE-marked medical devices and IVDs. From 13 December 2024, this will expand due to the General Product Safety Regulation (EU) 2023/988 – GPSR.

What this means:

Every manufacturer located outside the EU that sells non-food consumer products in the EU must appoint an EU Responsible Person (EURP). The goal is to ensure that every product sold in the EU has a clearly identifiable party inside the EU who is accountable for safety, traceability, and incident handling.

For medical devices, the MDR/IVDR rules remain in place; the GPSR requirement comes in addition to them.

If your company does not yet have a EURP or EAR, it’s time to act now.

 

Stronger Duties for the EU Authorized Representative

The MDCG guidance 2022-16 clarified that an EAR is not merely an administrative contact but is legally responsible for compliance.

Key points:

• An EAR may be held liable if a non-EU manufacturer fails to meet regulatory obligations.
• Every EAR must have a PRRC (Person Responsible for Regulatory Compliance) available to oversee MDR/IVDR compliance.
• When changing EARs, the handover must be documented carefully, including updates to labels and Declarations of Conformity.

QNET has an in-house, registered PRRC to ensure continuous compliance and regulatory support.

 

United Kingdom – Transition to UKCA with UKRP Support

Since Brexit, the UK has introduced its own product marking, known as UKCA.

While CE-marked devices are still accepted for now, the government has confirmed that UKCA will become mandatory for medical devices from 30 June 2028 (and for IVDs from 30 June 2030).

What this means:

• Manufacturers marketing products in the UK will face a dual route: CE for the EU and UKCA for the UK.
• Non-UK manufacturers must appoint a UK Responsible Person (UKRP) to manage registrations and communication with the MHRA.

QNET Ltd, office based in England, UK, provides full UKRP services and supports companies in preparing for UKCA labelling and registration well ahead of the deadlines.

 

Switzerland – CH-REP Remains Essential

As long as the Mutual Recognition Agreement (MRA) between the EU and Switzerland is not renewed, non-Swiss manufacturers must appoint a Swiss Representative (CH-REP).

The CH-REP:

• acts as the official contact point for Swissmedic,
• ensures that technical documentation is available in Switzerland,
• manages vigilance reporting and recalls.

QNET CH-REP GmbH is fully equipped to fulfill these statutory duties and can also manage the upcoming Swissmedic registration requirements.

 

United States – The Ongoing Need for a US Agent

For all non-US manufacturers placing medical devices on the US market, appointing a US Agent registered with the FDA remains mandatory. The US Agent serves as the primary point of contact for the FDA during inspections, safety inquiries, and any potential product recalls.

QNET LLC provides a US Agent service integrated with our EAR, UKRP, and CH-REP offerings — giving you one reliable partner across all major markets.

 

International Developments: IMDRF & MDSAP

The International Medical Device Regulators Forum (IMDRF) is playing an increasingly important role in harmonising global rules. On 4 September 2025, the MDCG’s International Matters Working Group reported several key updates:

• Adverse Events Terminology (AET) – updated global codes for incident reporting; training materials and an online test are planned for January 2026.
• Good Regulatory Review Practice (GRRP) – guidance to help regulators rely more on each other’s assessments (regulatory reliance), aiming to shorten market-authorisation timelines.
• Software as a Medical Device (SaMD) – efforts to align with the EU’s AI Act; particularly relevant for software-driven devices.
• Quality Management Systems (QMS) – post-COVID revisions focusing on CAPA and supply-chain robustness.
• Clinical Evidence for IVDs – a new guidance document is scheduled for public consultation in January 2026.
• AI / Machine Learning – still at an early stage but becoming a strategic priority for future international standards.

There is also growing pressure from MedTech Europe and some national regulators to encourage the EU to recognise MDSAP audit reports. Currently, 15 Notified Bodies participate in MDSAP. Recognition of MDSAP results could eventually reduce duplicate audits for manufacturers operating globally.

Why this matters to you:

Companies developing SaMD, AI-enabled devices, or IVDs should anticipate new international guidance over the next few years. Manufacturers who already hold MDSAP certification may benefit from reduced audit burdens in the future.

 

Emerging Opportunities in New Markets

Several new countries and regions are engaging with the IMDRF as observers or members, including Taiwan, Colombia, Indonesia, Ghana, and the Philippines. Many of these jurisdictions are introducing or considering reliance policies, meaning they may begin to recognise approvals or QMS certificates issued in the EU, US, or Japan. This trend can accelerate market entry for manufacturers once formalized.

 

Practical Next Steps

•             Assess whether your products fall under the new GPSR requirement and appoint an EURP or EAR if needed.
• Start preparations for the UKCA deadlines (2028/2030) well in advance.
• Maintain Swiss market access by appointing a CH-REP.
• Consider MDSAP certification to leverage potential recognition and reduce audit duplication.
• For SaMD, AI-based, or IVD products, monitor upcoming IMDRF guidance and plan for potential new documentation requirements.

With QNET, you gain a single partner for EAR/EURP, UKRP, CH-REP, and US Agent services, simplifying compliance and ensuring uninterrupted global market access.

 

Final Note

Global regulatory requirements are complex and constantly evolving. QNET’s mission is to translate these changes into clear guidance and actionable steps for your business — keeping you compliant, competitive, and market-ready.

QNET – Your trusted global partner for compliant and secure market access.