EU MDR Article 59 National Derogation: How to Place Medical Devices on the EU Market Without CE Marking in Exceptional Circumstances

The EU Medical Device Regulation (MDR 2017/745) established a rigorous conformity assessment framework that requires manufacturers to obtain CE marking before placing devices on the European Union market. This framework exists for good reason: it ensures that every device meeting patients and clinicians in the EU has been evaluated against defined safety and performance requirements.

But what happens when a patient needs a device that has not yet completed conformity assessment, and no CE-marked alternative exists?

Article 59 of the MDR provides the legal mechanism to address precisely this scenario. It allows EU Member State competent authorities to authorize, under strictly defined conditions, the placing on the market or putting into service of medical devices that have not gone through the full conformity assessment procedures required for CE marking. It is an exceptional pathway -- not an alternative route to market -- and understanding its scope, limitations, and practical operation is essential for regulatory affairs professionals working in or exporting to the EU.

This guide provides a comprehensive examination of Article 59, covering its legal basis, the authorization process, how different Member States implement it, the Commission's power to extend derogations EU-wide, and practical guidance for manufacturers considering this pathway.

Why Article 59 Exists

The MDR's conformity assessment system, while thorough, was not designed to handle every conceivable scenario. There are situations where the time required to complete full conformity assessment -- particularly when Notified Body capacity is constrained -- could result in patients being denied access to devices they urgently need.

Article 59 was drafted to address this gap. It recognizes that in certain circumstances, the public health interest or patient safety demands that a device be made available even when it has not yet completed the standard regulatory pathway. The provision is rooted in the principle that regulatory requirements should serve patients, not obstruct access to necessary medical technology when no reasonable alternative exists.

The article is deliberately narrow in scope. It is not a fast-track approval process, nor is it a mechanism for manufacturers to bypass MDR requirements. It is a safety valve, designed for exceptional situations where the normal regulatory framework would produce an unacceptable outcome for public health or patient safety.

The Legal Framework

Scope and Conditions

Article 59(1) establishes the core provision. It states that any competent authority of an EU Member State may authorize, on a duly justified request, the placing on the market or putting into service within its territory of a specific device for which conformity assessment procedures have not been carried out, provided that two conditions are met:

1. The use of the device is in the interest of public health, or patient safety or health.
2. The competent authority has considered how critical the device is and the availability of appropriate substitutes.

These conditions set a meaningful threshold. The authorization is not available simply because a manufacturer wishes to expedite market access. There must be a demonstrable connection to public health or patient safety, and the authority must evaluate whether CE-marked alternatives could serve the same purpose.

Territorial Limitation

A critical feature of Article 59 is that any authorization granted under it applies only within the territory of the Member State that issued it. If a manufacturer receives authorization from the German Federal Institute for Drugs and Medical Devices (BfArM), that authorization permits the device to be placed on the market only in Germany. To make the same device available in France, Italy, or any other Member State, the manufacturer would need to obtain a separate authorization from each country's competent authority.

This territorial limitation is one of the most significant practical constraints of Article 59. It means that for manufacturers seeking multi-country access, the derogation pathway requires navigating multiple national procedures with potentially different requirements, timelines, and levels of administrative capacity.

Temporary Nature

Derogations granted under Article 59 are intended to be temporary. The regulation does not specify an exact duration, leaving that determination to the competent authority. However, the spirit of the provision is clear: Article 59 is not a substitute for CE marking, and manufacturers are expected to pursue full MDR compliance concurrently with any derogation.

The temporary nature of these authorizations reinforces that Article 59 should be viewed as a bridge, not a destination. Manufacturers who treat it as a long-term market access strategy are misreading both the letter and the intent of the regulation.

The Authorization Process

Step-by-Step Overview

The following table summarizes the typical stages of the Article 59 authorization process:

Preparing the Request

The regulation requires a "duly justified request." While the MDR does not prescribe a specific format, manufacturers should expect to provide the following:

• Clinical justification: A clear explanation of the medical condition or patient population that the device addresses, and why existing CE-marked devices cannot adequately serve this need.
• Device description and technical documentation: Sufficient technical information for the competent authority to evaluate the device's safety and performance, even if full conformity assessment has not been completed. This should include risk analysis, clinical data (even if preliminary), and manufacturing information.
• Market analysis: Documentation of the current availability of CE-marked alternatives, including reasons why they are not suitable substitutes for the intended use or patient population.
• Public health or patient safety rationale: A direct argument connecting the device's availability to public health interests or patient safety outcomes.
• Proposed duration: While not always required, indicating an anticipated timeframe for the authorization helps the authority set appropriate conditions and reinforces the temporary nature of the request.

Competent Authority Evaluation

Once a request is submitted, the competent authority conducts its own assessment. This evaluation focuses on the two statutory criteria: whether the device serves a public health or patient safety interest, and whether the device is critical given the availability (or lack) of appropriate substitutes.

The authority has discretion in how it conducts this evaluation. Some Member States have published detailed procedures and evaluation criteria, while others handle requests on a more ad hoc basis. This variability is one of the practical challenges of the Article 59 pathway, which is discussed in further detail below.

Notification and Transparency

Member State Notification Obligations

Article 59(2) requires that when a Member State grants an authorization for use other than for a single patient, it must inform the European Commission and the other Member States. This notification mechanism serves several purposes:

• It ensures transparency across the EU, allowing other Member States to be aware of devices that have been authorized without CE marking in neighboring countries.
• It provides the Commission with visibility into how Article 59 is being used across the Union, which may inform policy decisions or the exercise of its own powers under Article 59(3).
• It allows other Member States to consider whether similar authorizations might be appropriate in their own territories, potentially facilitating faster access in additional countries.

For authorizations limited to a single patient, the notification requirement does not apply. This recognizes that individual patient cases, often involving compassionate use or custom-made devices for rare conditions, do not raise the same systemic concerns as broader authorizations.

What This Means in Practice

The notification requirement adds an administrative step but also creates an information resource. Manufacturers should be aware that their authorization -- and the justification for it -- will be shared with regulators across the EU. This transparency can be beneficial if the manufacturer later seeks authorization in other Member States, as it establishes a precedent and provides a reference point for other competent authorities.

EU-Wide Extension: The Commission's Power Under Article 59(3)

The Extension Mechanism

Article 59(3) provides a critical escalation mechanism. In exceptional cases relating to public health or patient safety, the European Commission may extend the validity of a Member State's authorization to the entire EU territory for a limited period. This extension is accomplished through implementing acts adopted via the examination procedure.

This provision addresses the inherent limitation of Article 59's territorial scope. If a device has been authorized in one Member State and the need for it exists across the EU, Article 59(3) provides a legal mechanism to make that device available Union-wide without requiring the manufacturer to obtain separate authorizations from each of the 27 Member States.

When Extension Is Appropriate

The Commission's power under Article 59(3) is reserved for exceptional cases. The regulation does not define "exceptional" with specificity, but the requirement that the extension relate to public health or patient safety sets a high bar. The Commission is expected to exercise this power judiciously, reserving it for situations where the scale or urgency of the public health need justifies overriding the normal territorial limitation.

The Examination Procedure

Implementing acts under Article 59(3) are adopted through the examination procedure, which involves consultation with the Member States through a committee. This process provides a check on the Commission's power, ensuring that EU-wide extensions reflect a collective assessment rather than a unilateral decision.

The examination procedure typically involves the following steps:

1. The Commission drafts a proposed implementing act extending the authorization.
2. The proposal is submitted to the relevant committee composed of Member State representatives.
3. The committee delivers an opinion on the draft.
4. If the opinion is favorable, the Commission adopts the implementing act.
5. If the opinion is not favorable, the matter may be referred to an appeal committee.

This process, while thorough, takes time -- which is why Article 59(4) exists.

The Urgency Procedure: Article 59(4)

Article 59(4) addresses situations where even the examination procedure is too slow. On duly justified imperative grounds of urgency relating to health and safety, the Commission may adopt immediately applicable implementing acts.

The urgency procedure is the most expedited mechanism available under Article 59. It allows the Commission to bypass the normal committee consultation process and extend a Member State's authorization to the entire EU with immediate effect. However, this power is subject to strict conditions:

• The urgency must be "duly justified" and "imperative."
• It must relate specifically to health and safety.
• The Commission must still act through an implementing act (it cannot simply issue a statement or press release).

The urgency procedure was most notably invoked during the COVID-19 pandemic, when the need for medical devices -- particularly personal protective equipment, ventilators, and in vitro diagnostic tests -- far outstripped the capacity of the standard conformity assessment system.

The COVID-19 Precedent

The COVID-19 pandemic provided the most significant real-world test of Article 59 and related derogation mechanisms. As the virus spread across Europe in early 2020, the demand for certain medical devices surged dramatically, and the supply of CE-marked devices was insufficient to meet the need.

Commission Recommendation of 13 March 2020

On March 13, 2020, the European Commission published a Recommendation encouraging Member States to make full use of Article 59 and other derogation mechanisms to facilitate access to critical medical devices during the pandemic. The Recommendation specifically highlighted that Member States could authorize the placing on the market of devices that had not completed conformity assessment, provided the conditions of Article 59 were met.

How Article 59 Was Used

During the pandemic, several Member States adopted national exemptions from CE-marking requirements for devices including:

• Personal protective equipment (PPE): Masks, gloves, and gowns needed in massive quantities for healthcare workers.
• Ventilators: Critical care devices for which demand far exceeded the supply of CE-marked units.
• In vitro diagnostic tests: Testing devices needed to identify and track infections, many of which were being developed by new manufacturers who had not previously gone through EU conformity assessment.

The COVID-19 experience demonstrated both the value and the limitations of Article 59. On the value side, it provided a legal mechanism that allowed Member States to act quickly to address urgent public health needs. On the limitations side, the fragmented nature of the response -- with each Member State handling derogations differently -- highlighted the challenges of relying on a nationally administered exception process during a Union-wide crisis.

The pandemic also accelerated the use of the Commission's extension power under Article 59(3), providing a template for how EU-wide derogations could work in practice.

Member State Implementation: A Fragmented Landscape

One of the most significant practical challenges of Article 59 is that its implementation varies widely across the 27 EU Member States. A study published in February 2026 in Frontiers in Medical Technology by Haon et al. examined how Member States approach Article 59 and related compassionate use mechanisms, finding substantial variation in both formal procedures and practical implementation.

Key Findings from the 2026 Study

The Haon et al. study revealed several important patterns:

• At least half of EU Member States operate some form of compassionate or expanded access scheme that can be used in connection with Article 59.
• The landscape remains fragmented and unevenly documented. Many Member States have not published detailed guidance on how they handle Article 59 requests.
• Central and Eastern European Member States commonly rely on Article 59, often because they have fewer domestic manufacturers with CE-marked devices and face greater challenges in securing access to the latest medical technology through standard market channels.

Notable Member State Approaches

The following table summarizes the approaches of several Member States identified in the research:

Implications of Fragmentation

The fragmented implementation of Article 59 creates several challenges for manufacturers:

• Unpredictable timelines: Without standardized procedures, the time required to obtain an authorization can vary significantly from one Member State to another.
• Inconsistent documentation requirements: Some Member States require extensive technical dossiers, while others have more streamlined processes.
• Variable administrative capacity: Not all competent authorities have the same resources or expertise to evaluate Article 59 requests, which can lead to delays or inconsistent outcomes.
• Information asymmetry: The lack of publicly available information about Article 59 procedures in many Member States makes it difficult for manufacturers to plan and prepare their applications effectively.

Relationship with Article 97

Article 59 is not the only derogation provision in the MDR. Article 97(1) also allows for derogation from certain MDR requirements and can be used alongside Article 59 in specific situations, particularly those related to transition periods.

Article 97 is primarily relevant in the context of legacy devices -- devices that were lawfully placed on the market under the previous Medical Device Directive (MDD) or Active Implantable Medical Device Directive (AIMDD) and are transitioning to MDR compliance. In cases where a device's certificate has expired or conformity assessment is ongoing, Article 97 can provide a legal basis for continued market availability while the manufacturer completes the MDR conformity assessment process.

The interplay between Articles 59 and 97 is relevant for manufacturers of legacy devices who may be able to use both provisions in combination. For example, a manufacturer might use Article 97 to maintain market access for a legacy device while simultaneously pursuing Article 59 authorization in a Member State where the device's certificate has expired and no CE-marked substitute is available.

Understanding which provision applies in a given situation requires careful analysis of the specific circumstances, including the device's regulatory history, the reason it lacks CE marking, and the nature of the public health or patient safety justification.

Limitations of Article 59

Not a Pathway to Permanent Market Access

Article 59 does not create a pathway to permanent EU market access. Any authorization granted under this provision is, by design, temporary and limited in scope. Manufacturers who view Article 59 as a shortcut to market entry are fundamentally misunderstanding its purpose and will eventually need to achieve full MDR compliance to maintain market presence.

Territory-Specific Authorizations

Each Member State requires a separate authorization. There is no mechanism under Article 59(1) or (2) for a single authorization to apply across multiple Member States. The only route to EU-wide authorization is through the Commission's extension power under Article 59(3), which is reserved for exceptional cases and requires the Commission to adopt an implementing act.

Lack of Standardization

The process for obtaining an Article 59 authorization is not standardized across Member States. As the Haon et al. study demonstrated, the landscape is fragmented, with some Member States having published detailed procedures and others providing little or no public guidance. This lack of standardization increases the burden on manufacturers, who must research and comply with different requirements in each target market.

No Guarantee of Authorization

Article 59 is discretionary. Competent authorities are not required to grant authorizations; they evaluate each request against the statutory criteria and may deny requests that do not meet the threshold. Manufacturers should not assume that an Article 59 request will be granted, even in situations where they believe the justification is strong.

Reputational and Commercial Considerations

Relying on Article 59 rather than achieving full CE marking may raise questions from customers, partners, and investors about a manufacturer's commitment to regulatory compliance. While Article 59 is a legitimate regulatory mechanism, it is intended for exceptional circumstances, and overreliance on it may be viewed unfavorably by stakeholders who expect manufacturers to meet the full requirements of the MDR.

Practical Guidance for Manufacturers

Use Article 59 Only as a Last Resort

The most important advice for manufacturers is straightforward: treat Article 59 as a last resort. The primary focus should always be on achieving full MDR compliance and obtaining CE marking through the standard conformity assessment process. Article 59 should be considered only when:

• CE marking is not yet achievable within the required timeframe.
• There is a genuine and demonstrable unmet medical need.
• No CE-marked alternative device exists that could serve the same purpose.

Prepare a Strong Justification

The strength of an Article 59 request rests on its justification. Manufacturers should invest significant effort in documenting:

• The specific medical need: What patient population or clinical scenario does the device address? Why is this need unmet by currently available CE-marked devices?
• The absence of alternatives: Conduct a thorough market analysis to demonstrate that no appropriate CE-marked substitute exists. Vague claims about the lack of alternatives will not satisfy a competent authority.
• The public health or patient safety connection: Draw a clear line between the device's availability and a specific public health or patient safety outcome. Generic statements about "improving patient care" are insufficient; the justification should be specific, evidence-based, and directly tied to the statutory criteria.

Document Everything

Maintain comprehensive records of all communications with competent authorities, supporting documentation submitted, and the terms and conditions of any authorization granted. This documentation serves several purposes:

• It provides a reference point if the manufacturer seeks authorization in additional Member States.
• It supports any future application for the Commission to extend the authorization EU-wide under Article 59(3).
• It demonstrates good-faith engagement with the regulatory process, which may be relevant if questions arise about the manufacturer's approach to compliance.

Engage Early with the Competent Authority

Do not wait until the need is urgent to initiate conversations with the relevant competent authority. Early engagement allows the manufacturer to understand the authority's specific requirements, expected timelines, and evaluation criteria. It also allows the authority to begin its assessment process sooner, reducing the risk of delays.

In Member States where Article 59 procedures are not well documented in public guidance, early engagement is particularly important. A pre-submission meeting or informal consultation can help clarify expectations and identify potential issues before a formal request is submitted.

Prepare for Different Procedures in Different Member States

Manufacturers seeking Article 59 authorizations in multiple Member States should expect and prepare for different procedures, timelines, and documentation requirements. What works in Germany may not work in Croatia, and the level of administrative support and responsiveness will vary.

To manage this complexity, manufacturers should:

• Identify target Member States early in the process.
• Research the specific procedures and requirements for each target country, including whether published guidance exists.
• Allocate sufficient resources to prepare and manage multiple parallel applications.
• Consider prioritizing Member States with more established or transparent procedures.

Continue Pursuing Full MDR Compliance in Parallel

This point cannot be overstated: manufacturers should use the time afforded by an Article 59 authorization to advance their full MDR conformity assessment. Article 59 is a temporary measure, and any market access it provides will end when the authorization expires. The only sustainable path to long-term EU market access is through full CE marking under the MDR.

Manufacturers should have a clear and realistic plan for achieving MDR compliance, including timelines for completing clinical evaluation, engaging with a Notified Body, and resolving any outstanding technical or regulatory issues. The Article 59 authorization should be viewed as buying time to complete this work, not as a reason to deprioritize it.

Consider the Broader Regulatory Strategy

Article 59 does not exist in isolation. Manufacturers should consider how it fits within their broader EU regulatory strategy, including:

• The potential use of Article 97 for legacy devices in transition.
• The timing and status of Notified Body applications for full MDR conformity assessment.
• The device's classification and the applicable conformity assessment route.
• Any ongoing clinical investigations or post-market surveillance activities that may support future CE marking.

A well-coordinated regulatory strategy that accounts for all available pathways will position manufacturers to respond effectively to changing circumstances and maintain market access over the long term.

Conclusion

Article 59 of the EU MDR provides a legally sound mechanism for making medical devices available in exceptional circumstances when the standard conformity assessment process cannot meet an urgent public health or patient safety need. It is a necessary feature of a well-designed regulatory system -- one that recognizes that rules designed to protect patients should not, in extraordinary cases, prevent them from accessing the care they need.

However, Article 59 is and must remain an exceptional pathway. Its territorial limitations, temporary nature, fragmented implementation across Member States, and discretionary character make it unsuitable as a primary market access strategy. The 2026 study by Haon et al. underscored the uneven landscape across the EU, with some Member States providing clear, transparent procedures and others operating with little public documentation.

For regulatory affairs professionals, the key takeaway is clear: understand Article 59, know when it applies, and be prepared to use it when necessary. But never lose sight of the fact that full MDR compliance and CE marking remain the only durable foundation for accessing the EU medical device market. Article 59 is a bridge, not a destination -- and the most effective regulatory strategies are those that use it sparingly and always in parallel with a committed pursuit of full conformity assessment.