EU MDR Compliance for Legacy Medical Devices: New Guidance

Legacy devices are products that were legally certified under older directives (MDD) but are allowed to remain in EU market. The EU MDR has released new guidelines for legacy devices. Legacy devices will have to mandatorily comply with these guidelines to continue in the EU market. We have prepared a detailed guide on EU MDR compliance for legacy devices.

What are legacy devices?

Legacy devices are older medical devices that were legally placed on the market under previous regulatory frameworks (such as the EU’s MDD, AIMDD, or IVDD) and continue to be marketed during a transition period to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). They are allowed to remain on the market during a defined transition period, provided certain conditions are met. Legacy devices were CE-marked under the former directives (MDD, AIMDD, or IVDD).

Examples of legacy devices:

• Implantable devices: Pacemakers, defibrillators, or orthopedic implants (e.g., bone screws, plates) that secured certifications before the deadlines.
• Imaging and diagnostic equipment: Older CT scanners, MRIs, or X-ray machines still in operation.
• In vitro diagnostics (IVD): Blood analyzers or test kits holding a valid IVDD certificate.
• Active devices: Autoclaves, infusion pumps, and ventilators previously certified under the MDD or AIMDD.
• Surgical instruments and accessories: Surgical staples, dental implants, and connectors. 

EU MDR compliance for legacy medical devices

European Commission’s Medical Device Coordination Group (MDCG) has issued new guidance on implementing and applying MDR requirements to legacy devices. New guidance and amendments have significantly shifted the landscape for legacy medical devices to prevent market shortages while ensuring safety.

EU MDR compliance for legacy medical devices requires that devices originally CE-marked under the old Directives (MDD, AIMDD, IVDD) can remain on the EU market until 2027–2028, provided they meet strict conditions. There should be no significant changes to design or intended purpose to maintain EU MDR compliance for legacy medical devices. Manufacturers are required to maintain an MDR-aligned Quality Management System and implement MDR-level post-market surveillance and vigilance systems. Additionally, manufacturers must also ensure packaging, sterilization, and clinical evidence meet MDR standards while proactively preparing for full MDR/IVDR transition before the extended deadlines. This framework balances patient safety with market continuity, giving companies time to adapt without disrupting healthcare supply.

New guidance on EU MDR compliance for legacy medical devices

The latest guidance on EU MDR compliance for legacy medical devices clarifies how legacy medical devices, those CE-marked under the old directive (MDD), can remain in the market until 2027–2028. As per the guidance, manufacturers must meet strict conditions on post-market surveillance, packaging/sterilization, and should not introduce “significant changes” to design or intended use of the device.

Conditions for maintaining legacy status of the medical device under EU MDR

We have highlighted the conditions for maintaining legacy status of the medical device under EU MDR. Manufacturers can continue marketing legacy devices if:

• The medical device was lawfully CE-marked under MDD/AIMDD/IVDD before MDR/IVDR enforcement.
• No significant changes are made to the design or intended purpose.
• The manufacturer maintains a compliant Quality Management System (QMS) aligned with MDR requirements.
• Post-market surveillance and vigilance systems are upgraded to MDR standards

New guidance requirements to maintain EU MDR compliance for legacy medical devices

The new EU MDR guidance requires manufacturers of legacy medical devices to maintain MDR-level systems for quality, post-market surveillance, and vigilance, while ensuring no significant changes to design or intended purpose are made during the transition period.

7 Key requirements for EU MDR compliance for legacy medical devices

1. Quality management system (QMS): Legacy devices must be supported by a QMS aligned with MDR Article 10.Even though the legacy medical devices were already CE-marked under MDD/AIMDD/IVDD, manufacturers must upgrade documentation, risk management, and supplier controls to MDR standards. QMS must cover clinical evaluation, vigilance, PMS, and corrective actions.
2. Post-market surveillance (PMS) and vigilance: MDR-level PMS obligations will be applicable. Periodic safety update reports (PSURs) for Class IIa and higher devices, trend reporting of non-serious incidents, and proactive data collection (registries, literature, clinical follow-up) will be required. Moreover, vigilance reporting timelines (serious incidents within 15 days, etc.) will be applicable to legacy devices.
3. No significant changes: Devices must remain unchanged in design and intended purpose. Any major modification (e.g., new materials, new indications, altered sterilization methods) would trigger MDR conformity assessment. Only minor administrative or manufacturing changes are permitted to continue the legacy device status.
4. Packaging and sterilization evidence: Manufacturers must validate packaging integrity and sterilization processes under MDR standards. Documentation must demonstrate shelf-life stability, sterility assurance, and transport robustness. Any change in packaging or sterilization method may require MDR certification.
5. Regulatory documentation: Legacy devices must be supported by updated technical documentation that reflects MDR PMS and vigilance requirements. Notably, article 19 MDR (concerning reprocessing of single-use devices) does not apply to legacy devices but other MDR obligations do.
6. Updated clinical evidence (MDCG 2020-6): The MDCG 2020-6 guidance clarifies that legacy devices require proof of performance. Manufacturers must demonstrate “sufficient clinical evidence” based on a qualified assessment of both pre-market and post-market data. The guidance provides a ranking system where high-quality clinical investigations are preferred. However, for well-established technologies (WET), like sutures or dental braces, lower-ranked data, like post-market surveillance (PMS) and literature reviews, may be acceptable.
7. EUDAMED and traceability: The timeline for the EUDAMED database has been updated to become progressively mandatory starting in 2025. While legacy devices are often exempt from full Unique Device Identification (UDI) labeling on the product itself, they must still be registered in EUDAMED to maintain market access.

Compliance challenges

We have presented major compliance challenges manufacturers face when managing legacy medical devices under EU MDR.

1. Post-market surveillance upgrades: Many manufacturers struggle to collect sufficient real-world evidence for older devices that lack robust clinical data.
2. No significant design changes: Even minor updates (materials, sterilization methods, software tweaks) risk being classified as “significant,” thereby forcing full MDR re-certification.
3. Packaging and sterilization validation: Legacy devices often lack modern validation files and suppliers may not provide adequate documentation, thereby creating audit risks.
4. Quality management system alignment: Manufacturers are required to upgrade risk management, supplier oversight, and vigilance processes. Hence, they have to perform costly system overhauls.
5. Transition deadlines and resource pressure: Notified bodies face capacity constraints, and manufacturers risk bottlenecks if they delay transition planning. Moreover, smaller firms struggle with resource allocation and documentation readiness.

5 pro tips for easy EU MDR compliance for legacy medical devices

1. Upgrade post-market surveillance early: Treat PMS as the backbone of compliance. Implement MDR-level PSURs, trend reporting, and proactive clinical follow-up now, even if deadlines are years away.
2. Document “no significant changes” clearly: Maintain a change log that tracks every design, material, or process update. Justify why changes are not significant under MDR definitions. This protects against regulatory disputes and ensures smooth audits.
3. Strengthen supplier and packaging validation: Audit suppliers for packaging integrity and sterilization validation. Collect shelf-life, transport stability, and sterility assurance data in advance. Weak supplier documentation is one of the most common audit failures.
4. Align QMS with MDR Article 10: Even though devices are legacy, your QMS must meet MDR standards. Update SOPs for vigilance, risk management, and CAPA systems. Train teams on MDR expectations to ensure operational discipline.
5. Plan MDR transition strategically: Prioritize high-risk or high-revenue devices for early MDR submissions. Engage with notified bodies early to avoid bottlenecks and capacity issues.

Hence, new guidance on EU MDR compliance for legacy medical devices has been formulated to prevent market shortages while ensuring safety. Thus, it is important to comply with these requirements to remain in the EU market. We at Pharmadocx Consultants offer dedicated service for CE marking and EU MDR compliance for medical devices. Email at [email protected] or call/Whatsapp on 9996859227 to avail our services.