Missed the May 26, 2024 MDR Notified Body Deadline? Your Emergency Exit Options for Legacy MDD Devices

The Deadline You Missed — And What It Means Right Now

Under Regulation (EU) 2023/607, manufacturers of legacy MDD/AIMDD devices had to meet two hard deadlines to benefit from the extended MDR transition periods:

1. May 26, 2024: Lodge a formal application for MDR conformity assessment with a Notified Body and implement an MDR-compliant QMS under Article 10(9).
2. September 26, 2024: Sign a written agreement with that Notified Body for the conformity assessment.

If you missed either deadline, your device no longer qualifies as a legacy device under the transition extension. This is not a warning — it is the current legal reality as of April 2026.

This guide is for the manufacturers that did not meet those conditions. It covers what happens next, what your options are, and what the concrete consequences look like by device class.

Your Device's Legal Status Today

A device that failed to meet the May 26 / September 26, 2024 conditions falls into one of two categories:

Category A: Devices with valid MDD certificates that expired after March 20, 2023

These certificates had their validity extended by Regulation (EU) 2023/607 — but only if the manufacturer met the application and agreement deadlines. Since the conditions were not met, the extended validity does not apply. The certificate is treated as having expired on its original expiry date or, at the latest, on May 26, 2024.

Legal status: The device cannot lawfully be placed on the EU market or made available. It is not a "legacy device." It is an uncertified device.

Category B: Devices with MDD certificates that expired before March 20, 2023

Under Regulation (EU) 2023/607, Article 120(2), certificates that expired before March 20, 2023 could benefit from an extension — again, only if the conditions were met. Without meeting the conditions, the certificate remains expired.

Legal status: Same as Category A. The device has no valid CE certificate and cannot be placed on the EU market.

Category C: Devices that never had a Notified Body certificate (MDD Class I self-certified, up-classified under MDR)

Class I devices that were self-certified under MDD but are up-classified under MDR (e.g., Class Is, Im, IIa, IIb, III) needed to lodge an application and sign an agreement by the same deadlines. If you missed them, the device cannot continue to be placed on the market under the old self-certified MDD declaration.

Legal status: The device must comply with MDR — there is no fallback. You cannot revert to MDD self-certification.

Forced Market Withdrawal: What Actually Happens

The sell-off removal changes everything

Regulation (EU) 2023/607 removed the "sell-off" date from MDR Article 120(4) for devices that qualify as legacy devices. This was a major relief for compliant manufacturers — devices already in the supply chain can continue to be sold indefinitely.

However, this sell-off removal only benefits devices that met the transition conditions. For non-qualifying devices:

• Devices already placed on the market before losing legacy status: These can continue to be sold through existing supply chain stock. The MDR does not require active recall of individual units already sold to end users.
• Devices not yet placed on the market: These cannot be placed on the EU market. Continuing to ship them constitutes a regulatory violation.
• Active withdrawal orders: National competent authorities (BfArM in Germany, ANSM in France, etc.) have the power to order withdrawal of non-compliant devices from the market. The risk of enforcement varies by member state, but the legal exposure is real.

Member state enforcement patterns

Member State	Authority	Enforcement Approach (2025-2026 observations)
Germany	BfArM / Paul-Ehrlich-Institut	Active market surveillance. Non-compliant devices identified through EUDAMED cross-referencing and NB reporting. Withdrawal orders issued.
France	ANSM	Increasing inspections. ANSM has issued guidance reminding manufacturers of the non-legacy device consequences.
Italy	Ministero della Salute	Enforcement primarily through import controls and distributor audits.
Spain	AEMPS	Moderate enforcement. Focus on higher-risk devices.
Netherlands	CIBG / IGJ	Structured surveillance with emphasis on hospital-sourced devices.

Emergency Exit Option 1: Fresh MDR Application Route

This is the primary pathway back to market. You submit a new MDR conformity assessment application to a Notified Body, starting the process from the beginning.

What is required

Requirement	Details
MDR technical documentation	Full technical file to MDR Annex II and Annex III standards
Clinical evaluation	MDR Article 61 clinical evaluation, including systematic literature review, clinical data analysis, and PMCF plan
QMS documentation	MDR Article 10(9) compliant QMS (ISO 13485:2016 aligned)
General Safety and Performance Requirements (GSPR)	Full GSPR checklist per MDR Annex I
Post-market surveillance system	PMS plan, PSUR schedule, vigilance procedures per MDR Articles 83-86
UDI assignment	Basic UDI-DI and UDI-DI per MDR Article 27 and Part C of Annex VI
EUDAMED registration	Actor registration and device registration from May 28, 2026

Timeline

The current average MDR certification timeline is 13 to 18 months for a successful review, and longer for complex devices. This reflects Notified Body capacity constraints that have been well documented since 2023. The bottleneck is particularly severe in 2026-2027 as the December 31, 2027 deadline for Class III and implantable Class IIb devices approaches.

Cost estimate

Cost Component	Typical Range
Notified Body fees (new MDR assessment)	€15,000-€80,000+ depending on device class and scope
Technical documentation rewrite (MDD → MDR)	€20,000-€100,000 for Class IIb/III devices
Clinical evaluation report (MDR standard)	€15,000-€60,000
QMS upgrade to MDR Article 10(9)	€10,000-€30,000
Regulatory consultant support	€20,000-€80,000
Total	€80,000-€350,000+ for a Class IIb/III device

Critical consideration: Notified Body capacity

As of early 2026, Notified Bodies are reporting unprecedented demand from manufacturers rushing to meet the December 2027 and 2028 deadlines. Manufacturers submitting fresh applications should expect:

• Queue times of 3-6 months before review begins for new applicants without existing NB relationships
• Longer review cycles for devices requiring clinical data evaluation under MDR Article 61
• Higher rejection rates for incomplete submissions — NBs are less tolerant of gaps given their workload

Emergency Exit Option 2: Device Relabeling and Repackaging

In limited circumstances, a manufacturer may explore whether the device can be placed on the market through a different regulatory pathway that does not require the missed MDD/MDR transition.

When this applies

• Custom-made devices: Class III implantable custom-made devices had a separate deadline (May 26, 2026) and different conditions. If your device qualifies as genuinely custom-made under MDR Article 2(3), this pathway may remain open.
• System or procedure packs: Under MDR Article 22, assemblers of systems and procedure packs have separate obligations. If your product can legitimately be reconceived as a system/procedure pack, the regulatory pathway differs.
• Reclassification: If MDR reclassification moved your device into a different class, assess whether the new classification actually simplifies the conformity assessment route.

Limitations

Relabeling a device to avoid regulatory requirements is itself a violation. The device's intended purpose, design, and clinical claims must genuinely support any alternative classification or pathway. This option requires careful legal and regulatory analysis and should not be pursued without competent regulatory counsel.

Emergency Exit Option 3: Sell-Off Existing Stock

For devices already lawfully placed on the EU market before the loss of legacy status, Regulation (EU) 2023/607's removal of the sell-off date means those specific units can continue to be distributed.

How it works

• Stock already in the EU supply chain (with distributors, hospitals, pharmacies) can continue to be sold
• Stock held by the manufacturer or authorized representative within the EU that was placed on the market before the legacy status was lost can continue to be made available
• New production runs cannot be placed on the market without MDR certification

Practical limits

• This is a declining-asset strategy — you are selling through remaining stock with no ability to replenish
• Distributors will eventually switch to MDR-certified alternatives from competitors
• No regulatory modifications, updates, or new indications can be introduced to the stock

Emergency Exit Option 4: Market Exit and Strategic Re-Entry

For some manufacturers, the most pragmatic option is to withdraw from the EU market temporarily and re-enter when MDR certification is achieved.

Steps

1. Cease all new shipments to the EU market
2. Notify your EU Authorized Representative and all distributors in writing
3. Manage existing stock per the sell-off provisions described above
4. Begin the fresh MDR application (Option 1) with a realistic timeline of 18-24 months
5. Plan market re-entry once MDR CE marking is obtained

When this makes sense

• The EU market represents a small share of your total revenue
• The cost of maintaining a non-compliant market presence (liability, enforcement risk) exceeds the revenue benefit
• You need time to build a proper MDR technical file rather than rushing an incomplete submission

Specific Examples by Device Class

Class IIb Implantable (e.g., high-pressure contrast injectors)

Factor	Situation
MDR deadline for qualifying legacy devices	December 31, 2027
Your status (missed May 2024 deadline)	Not a legacy device. Cannot use the Dec 2027 extension.
Current legal status	Cannot be placed on the EU market since May 26, 2024 (or original certificate expiry)
Fresh MDR application timeline	15-24 months (implantable devices face the most scrutiny)
Approximate cost of fresh MDR certification	€100,000-€250,000+
Recommended action	Begin fresh MDR application immediately. Manage existing EU stock through sell-off. Consider whether product redesign could reduce classification.
Competitor risk	High — competitors with legacy status can sell until Dec 2027 while you are off-market

Class III (e.g., active implantable devices, artificial discs)

Factor	Situation
MDR deadline for qualifying legacy devices	December 31, 2027
Your status	Not a legacy device.
Current legal status	Cannot be placed on the EU market
Fresh MDR application timeline	18-30+ months (clinical data requirements are most demanding for Class III)
Approximate cost	€150,000-€350,000+
Specific MDR requirements	Full clinical investigation data per Article 61(4), SSCP per Article 32, implant card per Article 18
Recommended action	Start fresh MDR application as top priority. Engage a Notified Body immediately — queue times for Class III are the longest. Consider whether clinical data from other jurisdictions (FDA, TGA) can support the MDR clinical evaluation.

Class IIa (e.g., powered surgical tools, non-implantable active devices)

Factor	Situation
MDR deadline for qualifying legacy devices	December 31, 2028
Your status	Not a legacy device. Cannot use the Dec 2028 extension.
Current legal status	Cannot be placed on the EU market since May 26, 2024
Fresh MDR application timeline	12-18 months
Approximate cost	€80,000-€150,000
Recommended action	Class IIa MDR requirements are less onerous than Class III/implantable. This is the most achievable fresh application. Prioritize this if you have limited resources.

Class I Self-Certified, Up-Classified to IIa/IIb/III Under MDR

Factor	Situation
Your status	Was self-certified under MDD, now requires NB involvement under MDR
Deadline implications	Same May 2024 / September 2024 conditions applied
If missed	Cannot revert to MDD self-certification. Must complete full MDR conformity assessment.
Practical challenge	These manufacturers often have the least experience with Notified Body reviews and the most documentation gaps.

Commission Q&A Positions (2024-2026 Updates)

The European Commission has published several rounds of Q&A guidance relevant to the transition:

• Devices not qualifying for the extended transition: The Commission has confirmed that non-qualifying devices cannot benefit from any grace period. The transition conditions are strictly applied.
• No "sell-off" for non-qualifying devices: The sell-off removal only applies to devices that qualify as legacy devices. Non-qualifying devices that were already in the supply chain can still be sold through, but new placement on the market is prohibited.
• Parallel marketing: If a manufacturer obtains MDR certification for a replacement device, the MDD-certified legacy device and the new MDR device can be placed on the market in parallel — but only if the legacy device actually qualifies. If it does not, only the MDR-certified device can be marketed.
• Swissmedic and MHRA recognition: Both Switzerland (Swissmedic) and the UK (MHRA) have confirmed they recognize the MDR transition extension. For non-qualifying devices, this means the device also loses market access in Switzerland and, depending on CE marking validity, potentially in the UK as well.

Your Action Plan: A Prioritized Checklist

Priority	Action	Deadline
Immediate	Confirm the exact status of every device in your EU portfolio: does it qualify as a legacy device, or has legacy status been lost?	Within 1 week
Immediate	Cease all new shipments of non-qualifying devices to the EU market	Immediately
Week 1-2	Audit existing EU stock: what units are already in the supply chain and can be sold through?	Within 2 weeks
Week 2-4	Notify EU Authorized Representative, distributors, and importers of the compliance gap in writing	Within 4 weeks
Month 1-2	Select a Notified Body and begin the fresh MDR conformity assessment application process	Within 2 months
Month 2-4	Gap analysis: compare your existing MDD technical file against MDR Annex II/III requirements	Within 4 months
Month 3-6	Complete MDR technical documentation, clinical evaluation, and QMS upgrade	Within 6 months
Month 6-12	Submit complete MDR application to Notified Body	Within 12 months
Ongoing	Manage sell-through of existing stock while MDR certification is in progress	Continuous

Bottom Line

Missing the May 26, 2024 Notified Body application deadline — or the September 26, 2024 written agreement deadline — is not automatically fatal to your EU market presence, but it is serious. The device loses legacy status immediately. You cannot continue to ship new units. Your competitors with legacy status have until December 2027 or 2028 to complete their transition while continuing to sell.

The path back to market is a fresh MDR application, which takes 12-24+ months and costs €80,000-€350,000+. The sooner you start, the sooner you return. There is no regulatory workaround that replaces a proper MDR conformity assessment.