EU MDR & EUDAMED 2026: Action Plan for Small Manufacturers

2026 is a critical year for medical device manufacturers in the European Union. Multiple MDR transition deadlines are converging, EUDAMED becomes mandatory, and the Notified Body capacity crisis remains unresolved. For small manufacturers, the challenge is acute: limited resources, complex requirements, and a regulatory environment that is still evolving. This article provides a practical action plan to navigate the year ahead.

MDR Transition Deadline Timeline

The MDR (EU 2017/745) transition deadlines were extended by Regulation (EU) 2023/607, giving manufacturers additional time based on device risk class. The key dates are:

• May 26, 2026: Class III custom-made implantable devices must have an MDR certificate or a valid application lodged with a Notified Body.
• December 26, 2027: Class III and Class IIb implantable devices must fully transition to MDR.
• December 26, 2028: Remaining Class IIb, Class IIa, and Class I (sterile/measuring) devices must comply with MDR.

Important: These extended deadlines only apply to devices that had a valid MDD/AIMDD certificate before May 26, 2021, and where a Notified Body application has been lodged. New devices must comply with MDR immediately.

EUDAMED: Mandatory from May 28, 2026

The European Database on Medical Devices (EUDAMED) becomes mandatory for use from May 28, 2026. While some modules have been available voluntarily, the full system will now be required for regulatory compliance.

EUDAMED consists of six interconnected modules:

1. Actor registration: All economic operators (manufacturers, authorized representatives, importers) must register.
2. UDI/Device registration: Devices must be registered with their UDI-DI (device identifier) and relevant technical data.
3. Notified Body and certificates: NB designations and certificates are recorded.
4. Clinical investigations: Clinical investigations must be registered.
5. Vigilance and post-market surveillance: Serious incident reporting and field safety corrective actions.
6. Market surveillance: Competent authority activities and market surveillance results.

For small manufacturers, the immediate priority is ensuring your actor registration is complete, your UDI system is in place, and your devices are registered with the correct Basic UDI-DI and UDI-DI identifiers. Start this process now if you have not already — EUDAMED registration can take weeks to validate.

EU Commission Simplification Proposal (December 2025)

In December 2025, the European Commission published a simplification proposal (COM(2025) 1023) aimed at reducing the regulatory burden of the MDR and IVDR, particularly for SMEs and innovative devices. While this is a welcome development, it is critical to understand that this proposal is not yet law.

Key elements of the proposal include:

• Streamlined conformity assessment for low-to-medium risk devices, reducing NB involvement for certain Class IIa devices.
• Simplified clinical evaluation pathways allowing greater use of equivalence and literature for well-established technologies.
• Reduced documentation requirements for SMEs, including proportionate technical documentation for Class I devices.
• EUDAMED simplification with reduced data entry requirements and improved user interface.

Warning: Do not delay your compliance efforts based on this proposal. The legislative process typically takes 18–24 months. Plan for current requirements while monitoring the proposal’s progress through the European Parliament and Council.

Article 120: Legacy Device Provisions

Article 120 of the MDR provides transitional provisions for devices lawfully placed on the market under the MDD or AIMDD. Understanding these provisions is essential for planning your transition strategy.

Key conditions for Article 120 legacy device provisions:

• Valid MDD/AIMDD certificate: The device must have held a valid certificate issued before May 26, 2021 (or before the MDR application date).
• No significant changes: There must be no significant changes to the device design or intended purpose.
• Continued compliance: The device must continue to comply with the relevant directive (MDD or AIMDD).
• MDR post-market requirements apply: Even during the transition, PMS, vigilance, and registration requirements under the MDR already apply to legacy devices.
• NB application required: To benefit from the extended deadlines, manufacturers must have lodged an application with a Notified Body.

Notified Body Capacity Crisis

As of early 2026, approximately 39 Notified Bodies are designated under MDR. While this is an improvement from the initial MDR rollout, capacity remains severely constrained. The average wait time for a new NB application is 12–18 months, and some NBs have closed their intake for new clients entirely.

Strategies for managing the NB bottleneck:

• Apply to multiple NBs simultaneously: While not required, submitting inquiries to several NBs increases your chances of securing a timely slot.
• Prepare a complete technical file: NBs prioritize manufacturers with mature, well-prepared documentation. Incomplete submissions are deprioritized or returned.
• Consider smaller or newer NBs: Newly designated NBs may have shorter wait times. Verify their scope covers your device type.
• Engage in pre-submission dialogue: Many NBs offer pre-submission meetings to align expectations and reduce review cycles.

2026 Action Checklist for Small Manufacturers

Use this checklist to organize your compliance activities for 2026:

1. Q1 2026: EUDAMED preparation — Complete actor registration. Assign UDI-DIs to all devices. Prepare device registration data.
2. Q1 2026: NB engagement — If you have not already, lodge your application with a Notified Body. Document that the application is pending.
3. Q2 2026: EUDAMED registration — Complete device registration in EUDAMED by May 28 deadline. Verify all data is accurate.
4. Q2 2026: Technical documentation review — Ensure your technical file meets MDR Annex II and III requirements. Update clinical evaluation, risk management, and PMS documents.
5. Q3 2026: Post-market system activation — Ensure your PMS, vigilance, and PMCF systems are fully operational under MDR requirements, even for legacy devices.
6. Q4 2026: Budget planning for 2027 — Plan for NB audit fees, technical documentation updates, EUDAMED maintenance, and potential clinical investigations.

Cost Planning and Budget Allocation

Realistic budget ranges for a small manufacturer navigating 2026 MDR compliance:

• Notified Body fees: €30K–€120K for initial MDR certification audit (varies significantly by device class and NB).
• Technical documentation update: €20K–€80K for regulatory consulting to bring documentation from MDD to MDR standard.
• Clinical evaluation/CER: €40K–€150K depending on complexity, equivalence availability, and need for clinical investigations.
• EUDAMED registration and UDI: €5K–€15K for systems, training, and UDI issuing agency fees.
• QMS upgrade: €10K–€30K to update quality management system procedures for MDR alignment.
• Annual ongoing costs: €15K–€50K for NB surveillance, EUDAMED maintenance, PMS, and CER updates.