EU MDR Article 97 Derogations: Legacy Device Contingency Playbook

Comprehensive guide to EU MDR Article 97 derogations, including MDCG 2022-18, Addendum 1 restrictions, national competent authority processes, and contingency planning.

Scenario Question & Direct Answer

Scenario: Our MDD certificate has expired and our Notified Body will not issue our EU MDR certificate for another 6 months — how can we use Article 97 derogations to keep our medical device on the market, and what are the current rules?

Direct Answer: Under EU MDR Article 97(1), a Member State's Competent Authority (CA) may permit a non-compliant or legacy device to remain on the national market for a defined period (typically up to 12 months) to achieve compliance, provided it does not present an unacceptable risk to health or safety. MDCG 2022-18 harmonized this pathway, requiring manufacturers to demonstrate 'reasonable efforts' to transition (such as having a signed Notified Body contract under Regulation (EU) 2023/607). However, following the adoption of Regulation (EU) 2023/607, Addendum 1 to MDCG 2022-18 restricts this pathway to 'very exceptional situations' for devices that do not qualify for the automatic statutory extension. To navigate this, manufacturers must: (1) prove the device's safety profile (low risk, no active recalls), (2) provide evidence of a signed contract and application with a Notified Body, (3) justify why the transition was delayed (e.g., Notified Body bottleneck), and (4) request a formal non-compliance period from the national Competent Authority.

What is EU MDR Article 97 and how does it work?

The EU Medical Device Regulation (MDR 2017/745) establishes 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.

However, the MDR transition has been marked by significant capacity challenges, particularly within Notified Bodies, leaving many manufacturers facing gaps where their legacy certificates under the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) or Medical Device Directive (MDD 93/42/EEC) expire before their new MDR certificates are issued.

Article 97 of the MDR provides the legal mechanism to address precisely this scenario. Specifically, Article 97(1) establishes that where a competent authority of a Member State finds that a device does not comply with the requirements of the MDR, it shall require the manufacturer or their authorized representative to bring the non-compliance to an end within a reasonable and clearly defined period. Crucially, the authority may permit the device to remain on the market or put into service during this rectification period, provided that the device does not present an unacceptable risk to the health or safety of patients, users, or other persons.

Unlike Article 59 national derogations, which are granted in the interest of public health when no substitutes exist, Article 97 is designed as a mechanism for handling "other non-compliance" where there is no unacceptable risk, allowing the manufacturer a defined grace period to achieve compliance under the supervision of a Competent Authority.

This guide provides a comprehensive examination of Article 97, covering its legal basis, the role of the Medical Device Coordination Group (MDCG) 2022-18 guidance, the impact of Regulation (EU) 2023/607 and Addendum 1, national competent authority procedures, and a manufacturer's contingency playbook.

The role of MDCG 2022-18: Harmonizing non-compliance measures

To prevent divergent approaches among Member State Competent Authorities and to avert imminent risk of shortages of essential medical devices, the MDCG issued MDCG 2022-18 in December 2022. This position paper established a harmonized framework for applying Article 97(1) to legacy devices during the transition to the MDR.

The guidance was originally developed to address the potential supply shortages of legacy devices whose certificates were set to expire before the manufacturer could obtain an MDR certificate. It provided a harmonized approach for CAs to allow these devices to remain on the market temporarily, even if they were not yet fully MDR-compliant.

Under MDCG 2022-18, the application of Article 97(1) is governed by several core principles:

Case-by-Case Assessment: Competent Authorities must evaluate each request individually, considering the specific device, its clinical benefit, its safety history, and the reasons for the compliance gap.
Temporal Limitations: The non-compliance period must be reasonable and clearly defined. The guidance recommends that the period granted should not exceed 12 months, although extensions may be considered in justified cases at the CA's discretion.
No Unacceptable Risk: The primary prerequisite is that the device does not pose an unacceptable risk to the health or safety of patients, users, or public health. The manufacturer must present robust safety data, including post-market surveillance (PMS) and vigilance records, to support this claim.
Active Transition Efforts: The manufacturer must demonstrate that they have undertaken reasonable efforts to transition their device to the MDR. This includes adapting their Quality Management System (QMS) and submitting an application for conformity assessment to a Notified Body.

Scope limits: when Article 97 does not apply

MDCG 2022-18 (Section II) draws the boundary narrowly, and manufacturers should confirm these exclusions before investing in an Article 97 dossier:

Suspended or withdrawn certificates. Article 97 applies only where the MDD/AIMDD certificate was valid at the date of its expiry. If the Notified Body suspended or withdrew the certificate, Article 97 is off the table — the device is no longer a qualifying "legacy device."
Significant changes. A device that underwent a significant change in design or intended purpose (within the meaning of Article 120(3) MDR, as explained in MDCG 2020-3) falls outside the legacy-device transition and therefore outside this Article 97 pathway.
The signed-contract condition — and the narrow SME waiver. Under MDCG 2022-18 (Section IV), the manufacturer's MDR conformity-assessment application should already have been accepted by a Notified Body and a written agreement signed (Annex VII, section 4.3 MDR) before Article 97 is granted. This is the single most important eligibility test, and it is the one most likely to be missed. The CA may waive it, but only in a tightly defined case: the manufacturer is an SME, the MDD/AIMDD certificate had been issued by a Notified Body not yet designated under the MDR, and the SME can show it applied to a considerable number of relevant Notified Bodies and was rejected due to limited NB capacity (with rejection letters on file). A manufacturer that simply never applied, or that let its contract lapse, does not meet this waiver.

How Regulation (EU) 2023/607 and Addendum 1 restricted Article 97

The regulatory landscape shifted significantly in March 2023 with the adoption of Regulation (EU) 2023/607. This amendment extended the MDR transition periods for legacy devices (up to December 2027 for high-risk Class III and Class IIb implantable devices, and up to December 2028 for medium and low-risk Class IIb, Class IIa, and Class I sterile/measuring devices), provided that specific conditions were met:

The device continues to comply with the MDD or AIMDD.
There are no significant changes in the design or intended purpose of the device.
The device does not present an unacceptable risk to health or safety.
The manufacturer has established an MDR-compliant QMS by May 26, 2024.
The manufacturer has submitted a formal application for MDR conformity assessment to a Notified Body by May 26, 2024.
The manufacturer and the Notified Body have signed a written agreement (contract) by September 26, 2024.

For legacy devices that meet these conditions, the extension is automatic and statutory. However, what about devices that fail to meet these transition conditions—for instance, if the manufacturer missed the May 2024 application deadline or was unable to secure a Notified Body contract by September 2024?

In response to Regulation (EU) 2023/607, the MDCG published Addendum 1 to MDCG 2022-18 in June 2023. The addendum clarifies that because the transition deadlines have been extended by law, the reliance on Article 97 as a mechanism for legacy devices should be significantly curtailed.

Specifically, the addendum advises that:

The use of Article 97(1) for legacy devices is now limited to "very exceptional situations".
CAs should generally not apply Article 97(1) to devices where the manufacturer has not made reasonable efforts to transition to the MDR within the statutory deadlines of Regulation (EU) 2023/607.
Article 97 is not a workaround for manufacturers who failed to implement a compliant QMS or secure a Notified Body contract in time.

As a result, obtaining an Article 97 derogation in 2026 is far more difficult than it was in early 2023. Addendum 1 gives a concrete example of what counts as a "very exceptional situation": a case where the competent authority had already received information justifying the application of Article 97 before 20 March 2023 — the date Regulation (EU) 2023/607 entered into force. The reason this matters is spelled out in the addendum: where, after 20 March 2023, a CA requires a manufacturer to carry out the conformity assessment procedure under Article 97, the condition in Article 120(2) MDR (a signed written agreement with a Notified Body) is treated as not met, so the expired certificate is not considered valid and the extended transition period under Article 120(3a) MDR does not apply. In other words, for a device that does not already qualify for the statutory extension, voluntarily pulling the Article 97 lever in 2026 is a narrow, case-by-case exception — not a planning tool, and not a clean substitute for missing the 2023/607 milestones.

Qualifying criteria: 'Unacceptable risk' and 'reasonable transition efforts'

For a manufacturer seeking to navigate the Article 97 pathway in an exceptional situation, two key criteria must be satisfied and documented in detail:

1. Demonstration of No Unacceptable Risk

The manufacturer must prove that the device is safe and performs as intended, and that its continued availability does not present an unacceptable risk to patients or users. This evaluation is based on:

Historical Safety Data: A review of the device's market history, including total units distributed and the rate of adverse events.
Vigilance and Recalls: Evidence that the device is not subject to active safety alerts, field safety corrective actions (FSCAs), or recalls.
PMS Data: Analysis of recent post-market surveillance data, including feedback from clinical users and patient registry data.
Benefit-Risk Analysis: A documented benefit-risk assessment showing that the clinical benefit of the device remaining on the market outweighs the risk associated with its temporary non-compliance.

2. Evidence of Reasonable Transition Efforts

The manufacturer must demonstrate that they have taken active, verifiable steps to transition the device to the MDR, and that the compliance gap was not due to neglect. Verifiable evidence includes:

Notified Body Communications: Correspondence with Notified Bodies demonstrating active engagement, contract negotiations, or scheduling of audits.
MDR Application Status: Evidence of a submitted application, even if it was rejected or delayed due to capacity bottlenecks.
QMS Compliance: Verification that the manufacturer's quality management system has been updated to meet MDR requirements (including ISO 13485 alignment), even if the product-specific technical documentation is still under review.
Project Plan: A detailed, milestone-driven transition project plan showing a clear path to full MDR compliance within the requested grace period.

Step-by-step application playbook for competent authorities (BfArM, ANSM, HPRA)

While Article 97 is a regulatory procedure rather than a standard application process, manufacturers facing transition gaps must proactively engage with national Competent Authorities to initiate the procedure. This process varies significantly by Member State, particularly regarding documentation requirements, review timelines, and administrative fees.

Here is the step-by-step playbook for navigating the process with key European CAs:

Step 1: Pre-Submission Engagement and Scientific Advice

Before submitting a formal request, manufacturers should proactively contact the Competent Authority in the country where they or their Authorized Representative is established. Many CAs, such as Germany's BfArM (Federal Institute for Drugs and Medical Devices) or France's ANSM (National Agency for the Safety of Medicines and Health Products), offer formal scientific advice or pre-submission consultations. This allows the manufacturer to present their case, evaluate whether the CA is open to initiating an Article 97 procedure, and clarify the specific dossier requirements.

Step 2: Dossier Preparation

The manufacturer must compile a comprehensive dossier supporting the Article 97 request. The dossier should include:

A formal request letter outlining the non-compliance (e.g., certificate expiry) and the requested rectification period (typically up to 12 months).
Verifiable evidence of transition efforts, including Notified Body correspondence and QMS audit status.
A detailed transition project plan with specific milestones and timelines.
A comprehensive safety and performance dossier, including recent PMS reports, vigilance data, and a benefit-risk analysis.
Justification of clinical need and public health impact, demonstrating the potential for supply shortages or patient harm if the device is withdrawn.
The MDCG 2022-18 self-assessment checklist (if required by the specific CA).

Step 3: Formal Submission and CA Evaluation

The dossier is submitted to the CA via their national portal (e.g., the BfArM portal in Germany or the HPRA portal in Ireland). The CA evaluates the submission on a case-by-case basis, consulting with other Member States and the Commission where appropriate. The CA may request additional information or audit reports during this evaluation period, which can take several weeks or months.

Step 4: Issuance of National Measure and Notifications

If the CA is satisfied that the criteria are met, it will issue a formal national measure under Article 97(1), permitting the device to remain on the market for a defined period subject to specific conditions (such as regular progress reporting).

Crucially, under MDCG 2022-18, the CA must notify the Commission and the competent authorities of the other Member States of the measure. The manufacturer must also notify their Notified Body of the Article 97(1) derogation.

Step 5: Monitoring and Milestone Compliance

During the grace period, the manufacturer must strictly adhere to the milestones and conditions set by the CA. Under MDCG 2022-18 this includes a commitment to inform the CA immediately of any circumstance that could delay the conformity assessment, plus regular progress reporting against the agreed plan of action; the precise cadence is set by the CA case-by-case rather than by the guidance. Failure to meet milestones or the emergence of new safety risks can lead the CA to terminate the Article 97 measure and escalate under Article 95 MDR.

Which Competent Authority Handles Article 97, and What to Expect

A point that is easy to get wrong: Article 97 is a discretionary, ex officio market-surveillance remedy, not a fee-bearing licensing application. Unlike a CE conformity-assessment application, which a Notified Body prices against a published fee schedule, Article 97 is triggered by the competent authority (CA) after it performs an evaluation under Article 94 MDR and concludes that the device is non-compliant but presents no unacceptable risk. You do not "apply and pay" the way you would for a clinical-investigation authorisation; you make a proactive notification, supply a dossier, and the CA decides whether and on what conditions to grant a rectification period.

MDCG 2022-18 (Section V) also fixes the jurisdictional question: the CA that acts is the CA of the Member State where the manufacturer — or, for non-EU manufacturers, its authorised representative — has its registered place of business. That CA's written communication can then be used as evidence with the CAs of other Member States and with customs, and the leading CA must inform the other Member States' CAs of the measure. It does not, however, prevent another Member State's CA from taking its own duly justified national measures.

The table below summarises the national authorities most device teams encounter and how each implements Article 97. None of these authorities publishes a standardised Article 97 fee schedule or a statutory decision timeline; handling is case-by-case, and the figures sometimes quoted elsewhere for "Article 97 fees" are not drawn from an official schedule. Treat engagement as a scientific-dialogue and dossier-iteration process rather than a fixed-cost, fixed-time transaction.

Competent Authority	Country	National implementation and published handling of Article 97
BfArM / the Länder	Germany	Article 97 is transposed into national law by §97 of the Medizinprodukterecht-Durchführungsgesetz (MPDG). Market surveillance — including Article 97 non-compliance procedures — is carried out by the competent German authorities (principally the authorities of the federal states, with BfArM responsible for specific device categories in its remit). Engage the authority where your establishment is registered.
ANSM	France	The Agence nationale de sécurité du médicament et des produits de santé is the national competent authority for medical devices and handles Article 97 through its market-surveillance function, following MDCG 2022-18.
HPRA	Ireland	The Health Products Regulatory Authority is the national competent authority and applies MDCG 2022-18 through its market-surveillance procedures.

A practical implication of the case-by-case design: a manufacturer that needs coverage in several Member States should still initiate the dialogue with its lead CA first (the one where it is established), because that CA's Article 97 decision is the document that unlocks recognition elsewhere. Expecting identical handling, identical fees, or identical timelines across BfArM, ANSM, and HPRA misunderstands the mechanism.

EU MDR Article 97 vs. Article 59: Key differences and when to use which

Manufacturers often confuse Article 97 and Article 59 national derogations, as both allow non-CE-marked devices to be placed on the market. However, they are distinct legal mechanisms with different criteria, processes, and strategic purposes.

Article 59 National Derogation

Legal Basis: Article 59(1) MDR.
Primary Trigger: Public health interest or patient safety/health necessity.
Key Requirement: Demonstration that the device is critical and that no CE-marked substitutes exist on the market.
Applicability: Applies to individual patients or specific groups of patients where there is an unmet clinical need.
Conformity Assessment Status: The device may not have even started conformity assessment; it may be an innovative device or a customized solution.

Article 97 Non-Compliance Derogation

Legal Basis: Article 97(1) MDR.
Primary Trigger: "Other non-compliance" of an existing device (such as certificate expiry during transition).
Key Requirement: Demonstration that the device does not present an unacceptable risk to health or safety.
Applicability: Applies to established devices transitioning to the MDR that face temporary certification gaps.
Conformity Assessment Status: The manufacturer must be actively pursuing MDR conformity assessment and have made reasonable efforts to transition.

The table below summarizes the key operational differences between the two pathways:

Feature	Article 59 Derogation	Article 97 Derogation
Primary Focus	Unmet clinical need (no substitutes exist)	Rectifying temporary non-compliance (gap transition)
Required Proof	Device is essential; substitutes are unavailable	Device does not pose an unacceptable risk to health/safety
Target Audience	Individual patients or narrow critical populations	Established user base for transitioning legacy devices
NB Contract Needed?	No	Yes (highly recommended/required under Addendum 1)
Duration	Temporary (often project/patient-specific)	Defined grace period (typically up to 12 months)
Territorial Scope	Strictly national territory	Strictly national (but with EU-wide CA notification)

For a detailed analysis of Article 59 national derogations, consult our dedicated EU MDR Article 59 national derogation guide.

A manufacturer's contingency playbook for certification gaps

If your medical device is facing a certification gap and you do not qualify for the automatic Regulation (EU) 2023/607 transition extension, you must act quickly to implement a contingency playbook:

graph TD
    A[Identify Certification Gap] --> B{Qualify for EU 2023/607 Extension?}
    B -- Yes --> C[Utilize Statutory Extension]
    B -- No --> D{NB Contract Signed?}
    D -- Yes --> E[Proactively Contact Competent Authority]
    D -- No --> F{Critical Public Health Need?}
    F -- Yes --> E
    F -- No --> G[Consider Market Withdrawal or Alternative Regions]
    E --> H[Prepare Article 97 Dossier]
    H --> I[Submit to Competent Authority]
    I --> J{Approved?}
    J -- Yes --> K[Execute Rectification Plan & Meet Milestones]
    J -- No --> G

Playbook Step 1: Conduct an Immediate Gap Assessment

Verify the exact expiry dates of all current MDD/AIMDD certificates and cross-reference them with your Notified Body's audit schedule. Assess whether you satisfy all transition conditions of Regulation (EU) 2023/607. If you identify a gap (e.g., your certificate expires in 3 months and the Notified Body's final report is scheduled in 9 months), immediately evaluate whether you qualify for the Article 97 pathway.

For further background on how these transition timelines are structured, see our guide on EU MDR transition timelines for legacy devices.

Playbook Step 2: Proactively Engage Your Notified Body

Secure a formal statement from your Notified Body confirming the status of your MDR conformity assessment, the signed written agreement, and the estimated date of certificate issuance. This statement is the single most critical piece of evidence for proving "reasonable transition efforts" to a Competent Authority.

For strategies on managing this relationship and avoiding common bottlenecks, consult our guide on EU MDR Notified Body certificate expiry cliff.

Playbook Step 3: Compile the Safety Dossier

Gather all PMS reports, clinical evaluation reports (CER), vigilance data, and risk files. Conduct a rigorous, documented review of the device's safety history to demonstrate that it poses no unacceptable risk. If the device has any outstanding CAPAs or active safety notices, address them immediately, as any open safety issues will lead to an immediate rejection of your Article 97 request.

Playbook Step 4: Formulate a Realistic Rectification Plan

Develop a detailed project plan with your regulatory and engineering teams showing how you will bring the device into full MDR compliance within a maximum of 12 months. Ensure that the milestones are realistic and that you have allocated sufficient budget and personnel to execute the plan.

If you miss these critical deadlines, you may need to consult our MDR missed deadline emergency exit guide to understand your alternative options, such as temporary market withdrawal or relocating inventory to other jurisdictions.

Frequently Asked Questions

Is Article 97 MDR a standard market access pathway?

No. Article 97 is an administrative enforcement mechanism used by competent authorities to manage non-compliance. It is designed as an exceptional "safety valve" to prevent patient harm from device shortages, not as a standard or planning-friendly regulatory pathway.

How long does an Article 97 non-compliance grace period last?

The duration of the grace period is at the sole discretion of the national Competent Authority. However, MDCG 2022-18 recommends that the period granted to bring the device into compliance should be reasonable and clearly defined, typically not exceeding 12 months.

Does an Article 97 authorization apply EU-wide?

No. Any measure taken by a Competent Authority under Article 97(1) applies only within the territory of the Member State that issued it. If you obtain an Article 97 agreement from Germany's BfArM, that agreement only permits marketing within Germany. You must proactively contact the CAs of other Member States where you wish to sell the device, though the notification under MDCG 2022-18 facilitates this process.

Can I apply for Article 97 if I do not have a signed contract with a Notified Body?

While not technically prohibited by the MDR text, MDCG 2022-18 Addendum 1 makes it clear that Article 97 should be restricted to "very exceptional situations" for devices that do not qualify for the Regulation (EU) 2023/607 extension. In practice, competent authorities are highly unlikely to grant a derogation if you cannot demonstrate active engagement and contract negotiations with a Notified Body.

What is the difference between Article 97 and Article 59 national derogations?

Article 59 is used in the interest of public health when no CE-marked alternatives exist to serve patients with critical unmet clinical needs. Article 97 is used to rectify administrative or transition non-compliance for established legacy devices that are safe but face temporary certification gaps.