EU MDR 2025–2028
What the Extension Means for Your Packaging, Testing, and Sterilization Strategy
Last updated: October 2025
The European Union’s Medical Device Regulation (EU MDR) transition period has been extended through 2028. Here’s what medical device manufacturers need to know about the new requirements — and how to protect packaging and sterilization compliance before the deadlines.
Watch: EU MDR 2025–2028 2-Minute Overview for Manufacturers
The EU MDR transition was extended, not relaxed. In two minutes, this overview explains the 2027/2028 deadlines, legacy-device conditions, and what packaging, testing, and sterilization evidence regulators expect under MDR. Use it to brief stakeholders and align your 2025–2026 plan.
Deadlines by class under Regulation (EU) 2023/607
Legacy eligibility and “significant change” risk
Packaging validation, distribution testing, and sterilization requirements (ISO 11607, ISO 14971, ISO 11135/11137/17665)
A practical 6-step readiness roadmap
EU MDR deadlines are extended—but expectations haven’t relaxed. Here’s what U.S. manufacturers need to do now.
Under Regulation (EU) 2023/607, Class III and implantable Class IIb devices may transition until May 26, 2027. Most other Class IIb, IIa, and Class I devices have until May 26, 2028.
“Legacy device” status requires a valid MDD or AIMDD certificate, no significant change to design or intended purpose, continued compliance, and a written agreement with an MDR-designated notified body.
MDR technical documentation must prove packaging system suitability and sterilization compatibility—aligned with ISO 11607 and risk management under ISO 14971. Expect evidence for distribution simulation, seal integrity, and shelf life.
Revalidate when materials or suppliers change, when package design is updated, when sterilization modality changes, or when labeling and UDI updates could affect the sterile barrier or documentation.
Changes that affect design or intended purpose can void legacy status. Use a formal change-evaluation process and consult your notified body when in doubt.
Your 2025–2026 readiness roadmap: start with a gap assessment; confirm classification and eligibility; secure notified-body capacity; complete packaging and sterilization validations; consolidate MDR-ready technical documentation; and maintain post-market surveillance and vigilance.
Life Science Outsourcing streamlines MDR readiness with integrated packaging validation, distribution testing, and sterilization validation under one quality system. Download the MDR Readiness Checklist or talk to a specialist.
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Why the EU MDR Extension Matters for Manufacturers
The EU Medical Device Regulation (MDR) represents the most significant overhaul of medical device oversight in Europe in more than two decades, replacing the former Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).
For U.S. manufacturers exporting to the EU, MDR compliance is not optional — it’s a prerequisite for continued market access.
In March 2023, the European Commission adopted Regulation (EU) 2023/607, extending MDR transition timelines to prevent market disruption caused by notified body (NB) capacity shortages and potential device shortages.¹
While this extension provides more time for certification, it also places new conditions on manufacturers — particularly those maintaining “legacy” device status under prior directives.
For many U.S. OEMs, the MDR extension is not simply a regulatory update — it’s a call to strengthen packaging validation, sterilization processes, and technical documentation before NB capacity fills up again.
MDR Transition Deadlines by Device Class (per Regulation (EU) 2023/607):
Class III and implantable Class IIb devices: until May 26, 2027
Other Class IIb, Class IIa, and Class I devices: until May 26, 2028
What’s Changed Under Regulation (EU) 2023/607
The 2023 amendment does more than extend timelines. It introduces new compliance conditions designed to ensure continuous safety oversight and discourage regulatory complacency.
Key Updates:
Removal of the “sell-off” deadline, allowing continued distribution of compliant legacy stock.¹
Mandatory NB engagement: manufacturers must have a written agreement with a notified body in place before specific dates (May–September 2024, depending on device class).²
Ongoing compliance under MDD/AIMDD: legacy devices must continue meeting their original conformity requirements until MDR certification is achieved.
Expanded post-market surveillance (PMS) and vigilance obligations for legacy devices.³
EUDAMED implementation continues to progress, reinforcing device traceability through the Unique Device Identification (UDI) system.⁴
In short, while the deadlines have moved, the expectations have not relaxed. The MDR extension is best viewed as a managed transition — not a delay.
How to Determine If Your Device Qualifies as a “Legacy” Device
The term legacy device refers to products that remain on the EU market under valid MDD/AIMDD certificates while transitioning to MDR compliance.
Not all devices qualify, and misinterpreting this status is a common risk for U.S. manufacturers.
Eligibility criteria include:
A valid MDD or AIMDD certificate issued before May 26, 2021.
No significant change to the device’s design or intended purpose.⁵
Continued compliance with the MDD/AIMDD requirements.
A written contract with an MDR-designated notified body (by 2024 deadlines).
No unacceptable risk to patients or users.
Devices that undergo material, design, or sterilization process changes may lose legacy status and require full MDR conformity assessment.
The implications are especially significant for products relying on sterile packaging or validated sterilization modalities.
Packaging and Testing Requirements Under MDR
New Emphasis on Packaging Validation and Technical Documentation
Under MDR Annex II and Annex III, manufacturers must provide verifiable evidence of packaging system suitability and sterilization compatibility within their technical documentation. This represents a substantial increase in packaging accountability compared to the former directives.
Core packaging and testing expectations include:
- Compliance with ISO 11607-1/-2 for packaging materials, sterile barrier systems, and validation processes.
- Integration of ISO 14971 risk management principles to identify and control packaging-related risks.
- Verification of packaging performance under distribution simulation and environmental stress (e.g., temperature, humidity, vibration).
- Compatibility validation between packaging and sterilization methods (EtO, gamma, steam, e-beam).
- Shelf-life determination through real-time and accelerated aging studies.
These validations are no longer optional. For MDR compliance, they must be traceable, reproducible, and integrated into the manufacturer’s quality management system.
When Revalidation Is Triggered:
Change in packaging supplier or materials
New sterilization process or site transfer
Design modifications affecting sterile barrier integrity
Labeling or UDI revisions affecting packaging design
Managing “Significant Changes” Without Losing Legacy Status
Under MDCG 2020-3, a significant change in design or intended purpose may disqualify a device from extension eligibility.⁵
For packaging and sterilization, even minor modifications can have major regulatory implications.
Examples of Potentially Significant Changes
Material substitution within a sterile barrier system
Change of sterilization modality (e.g., from EtO to gamma)
Introduction of new packaging equipment or processes
Alteration of package design affecting integrity or stability
Manufacturers are expected to document a change evaluation that justifies why a modification does or does not constitute a “significant change.” This assessment should include:
A technical rationale
Impact analysis on device performance and safety
Reference to applicable validation or revalidation data
NB notification (if required)
Best Practice: establish a documented design freeze for legacy devices through 2028 to preserve eligibility and minimize certification disruption.
Your 2025–2026 MDR Readiness Roadmap
To meet MDR expectations and avoid certification bottlenecks, U.S. OEMs should begin implementing a structured compliance plan now.
Step 1: Conduct a Gap Assessment
Evaluate your current packaging, sterilization, and documentation processes against MDR and ISO 11607 requirements. Identify where legacy device files are incomplete or outdated.
Step 2: Confirm Device Classification and Eligibility
Verify classification and confirm whether each product qualifies for MDR transition. Begin NB engagement early to secure assessment capacity.
Step 3: Update or Revalidate Packaging and Sterilization
Perform required validations for packaging integrity, shelf life, and sterilization reproducibility. Ensure all test data is traceable and linked to current device configurations.
Step 4: Implement Change Control Governance
Create a formal process for evaluating potential “significant changes.” Maintain a master record of supplier and material stability.
Step 5: Prepare Technical Documentation
Consolidate packaging validation, sterilization validation, and testing data into a single MDR-compliant technical file structure.
Step 6: Monitor and Maintain Compliance
Establish continuous post-market monitoring and revalidation cycles as part of your quality system.
Common Pitfalls That Delay MDR Certification
Even experienced manufacturers encounter avoidable delays when navigating MDR compliance. The most common include:
Late notified body engagement, resulting in scheduling backlogs.
Unverified packaging revalidation, particularly when supplier materials have changed.
Fragmented documentation, with testing data dispersed across multiple vendors.
Undefined change control processes, leading to loss of legacy eligibility.
Gaps in sterilization validation or environmental monitoring data.
Failure to align PMS and vigilance activities with MDR Article 83–86 requirements.
Partnering with a single-source provider simplifies documentation control and ensures testing, packaging, and sterilization data remain integrated within one quality system.
Looking Ahead to 2028 and Beyond
The EU MDR extension provides temporary relief — not permanent exemption. After 2028, all medical devices placed on the EU market must be certified under MDR.
Looking ahead, the global regulatory landscape is trending toward convergence:
The U.S. FDA’s forthcoming Quality Management System Regulation (QMSR) will align with ISO 13485:2016, bridging MDR expectations.⁶
Increased reliance on digital validation records, predictive modeling, and supply chain traceability will shape future conformity assessments.
Manufacturers that proactively align MDR, ISO, and FDA requirements will gain a strategic advantage in both compliance readiness and speed to market.
LSO continues to monitor evolving guidance and standards to help clients maintain certification continuity and technical file integrity.
Conclusion
The MDR extension through 2028 represents an opportunity — but not a pause. U.S. manufacturers should act now to secure notified body agreements, revalidate packaging and sterilization systems, and unify technical documentation under MDR expectations.
With more than 25 years of experience in medical device packaging, testing, and sterilization, Life Science Outsourcing (LSO) provides a single-source pathway to regulatory compliance and sustained EU market access.
EU MDR FAQs
What are the MDR transition deadlines under Regulation (EU) 2023/607?
Class III and implantable Class IIb devices may transition until May 26, 2027; other Class IIb, IIa, and Class I devices until May 26, 2028, subject to meeting extension conditions (e.g., notified-body agreement, no significant change).
What is a “legacy device” under the MDR extension?
A device covered by a valid MDD/AIMDD certificate that stays on the EU market during the transition, provided there is no significant change in design or intended purpose, the device continues to meet applicable requirements, and a written agreement with an MDR-designated notified body is in place.
What counts as a “significant change” that could void legacy status?
Per MDCG guidance, changes that affect design or intended purpose—such as material substitutions in the sterile barrier, sterilization modality changes, or modifications impacting performance—are often significant and may require MDR conformity assessment.
Do I still need packaging validation if I have legacy status?
Yes. MDR technical documentation must demonstrate packaging suitability and sterilization compatibility (e.g., alignment with ISO 11607-1/-2 and risk management per ISO 14971), regardless of legacy status.
When is packaging or sterilization revalidation required?
Revalidation is typically triggered by changes to packaging materials or suppliers, design updates affecting sterile barrier integrity, sterilization process changes or site transfers, updated labeling/UDI impacting packaging, or shifts in distribution conditions.
Which sterilization standards map to MDR expectations?
Commonly referenced standards include ISO 11135 (EtO), ISO 11137 (radiation), and ISO 17665 (moist heat). Evidence must show process capability, reproducibility, and compatibility with the packaging system.
What distribution/transport tests are expected?
Evidence of distribution robustness is typically shown via industry test methods (e.g., distribution simulation, shock/vibration, climatic conditioning). Results should be risk-based and referenced in the technical file alongside packaging validation.
Did the MDR extension remove the “sell-off” deadline?
Yes. Regulation (EU) 2023/607 removes the sell-off deadline, allowing continued distribution of compliant stock while transition conditions are met.
Which sterilization standards map to MDR expectations?
Commonly referenced standards include ISO 11135 (EtO), ISO 11137 (radiation), and ISO 17665 (moist heat). Evidence must show process capability, reproducibility, and compatibility with the packaging system.
How does EUDAMED/UDI affect packaging and labeling?
UDI assignment and device registration strengthen traceability. Packaging and labeling updates must be reflected in the technical documentation and may trigger verification or revalidation steps depending on impact.
What documentation should be in my MDR technical file for packaging/sterilization?
A structured file aligning with MDR Annex II/III typically includes: packaging design and material rationale, ISO 11607 validation reports, shelf-life/aging data, distribution testing, sterilization validation and routine control, risk management, and change-control records.
How do I avoid losing legacy eligibility while making necessary updates?
Implement a formal change-evaluation process against MDCG “significant change” criteria, maintain a design freeze where possible, consult your notified body when in doubt, and ensure any modifications are supported by updated validation and documented rationales.
What should U.S. manufacturers prioritize in 2025–2026?
Perform a gap assessment, confirm device classification and legacy status, secure notified-body engagement, complete required packaging/sterilization validations, formalize change-control governance, and consolidate MDR-ready technical documentation.
How does the FDA’s QMSR alignment with ISO 13485 affect MDR prep?
FDA’s QMSR alignment supports harmonization with ISO 13485 and can streamline your global QMS. It does not replace MDR requirements, but it can reduce duplication and clarify documentation expectations across markets.
Can LSO manage end-to-end testing, packaging, and sterilization under one quality system?
Yes. LSO provides integrated packaging validation, distribution testing, and sterilization validation with unified documentation and change-control support for MDR technical files.
References
European Commission. Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Official Journal of the European Union, March 20, 2023.
European Commission. Questions and Answers on the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Updated May 2023.
Medical Device Coordination Group (MDCG) 2022-6. Guidance on Periodic Safety Update Report (PSUR) for Medical Devices.
European Commission. EUDAMED and Unique Device Identification (UDI) Overview. Accessed 2025.
Medical Device Coordination Group (MDCG) 2020-3. Guidance on Significant Changes Regarding the Transitional Provisions Under Article 120 of the MDR and Article 110 of the IVDR.
U.S. Food and Drug Administration. Quality Management System Regulation (QMSR) Final Rule Aligning with ISO 13485:2016. January 2024.
Free PDF. No email required.
Typical response within 1 business day.
15-minute consult with a specialist.