EU Notified Body Selection and Change for Medical Devices: 2026 MDR Guide

How to select, evaluate, and change Notified Bodies under EU MDR and IVDR — capacity constraints, selection criteria, transfer process, 2026 implementing regulation, and timeline planning.

Why Notified Body Selection Matters More Than Ever in 2026

The choice of Notified Body has always been a consequential decision for medical device manufacturers targeting the European market. But in 2026, it has become a strategic variable with direct implications for market access, regulatory timelines, and commercial viability. The transition from the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC) to the Medical Device Regulation (MDR 2017/745) has compressed the Notified Body ecosystem, concentrated demand among fewer designated bodies, and extended review timelines to 13 to 18 months for a typical certification cycle.

Manufacturers who treated Notified Body selection as an afterthought under the MDD era are discovering that the decision now requires the same rigor applied to any major vendor or partner evaluation. The wrong choice can mean missed transition deadlines, delayed product launches, and in the worst case, loss of CE marking before a replacement Notified Body can complete its assessment.

This guide addresses two connected challenges that every medical device manufacturer operating under the MDR and IVDR must confront: how to select the right Notified Body in a constrained market, and how to execute a transfer from one Notified Body to another when circumstances demand it. Both processes are shaped by the 2026 regulatory landscape, including the European Commission's implementing regulation on Notified Body procedures, targeted MDR revisions that will reshape certificate management, and mandatory EUDAMED registration requirements taking effect May 28, 2026.

The 2026 Notified Body Landscape: Capacity, Constraints, and New Rules

Current Designation Numbers

As of early 2026, approximately 45 to 50 Notified Bodies hold designation under the MDR, compared to roughly 80 that operated under the MDD. For IVD manufacturers, the situation is tighter still: approximately 10 to 12 Notified Bodies are designated under the IVDR. This contraction was not accidental. The MDR's Annex VII designation criteria are substantially more demanding than the MDD's, and a significant number of former MDD Notified Bodies chose to withdraw from the market rather than invest in the infrastructure, personnel, and processes required to meet the new standard.

Metric	MDD Era (Pre-2021)	MDR (Early 2026)
Notified Bodies (medical devices)	~80	~45-50
Notified Bodies (IVDs)	~20 (under IVDD)	~10-12 (under IVDR)
Average certification timeline	6-12 months	13-18 months
Designation process for new NBs	~6 months	18-24 months

The Capacity Gap

The mathematics of the capacity problem are straightforward. Fewer Notified Bodies must absorb the workload previously distributed across a larger pool, and each individual assessment now requires substantially more effort under the MDR than it did under the MDD. Technical documentation reviews are deeper, clinical evidence expectations are higher, quality management system audits are more thorough, and post-market surveillance requirements are more extensive.

QbD Group, a regulatory consulting firm active in the EU medical device market, has summarized the situation plainly: "Manufacturers who delay submissions risk not being assessed in time." This is not marketing hyperbole. With the first MDR transition deadline for Class III devices approaching at the end of 2027, and the Class IIa/IIb deadline at the end of 2028, the queue for Notified Body assessment is lengthening. Manufacturers who submit applications in mid-2026 face realistic timelines of 13 to 18 months before certification is complete, assuming no significant nonconformities are found during the audit process. Complex devices -- implantables, combination products, software as a medical device -- can take even longer.

The practical consequence is that Notified Body selection in 2026 is not a matter of identifying the best partner from a list of equally available options. It is a matter of finding a Notified Body with the capacity, scope, and willingness to take on your devices within a timeframe that aligns with your regulatory deadlines.

Geographic and Structural Concentration

Designated MDR Notified Bodies are concentrated in a handful of EU member states. Germany, the Netherlands, Italy, and France account for the majority of designations. This geographic concentration has downstream effects on language capabilities, audit scheduling, and the availability of reviewers with expertise in specific device categories. Manufacturers based in other regions -- particularly those outside the EU -- may face additional complexity in finding a Notified Body with the linguistic and geographic reach to support their operations.

Notified Body Designation: Understanding Scope and How to Verify It

Before evaluating which Notified Body to approach, manufacturers must understand that Notified Bodies are not interchangeable. Each body is designated for a specific scope, and your device must fall within that scope for the Notified Body to perform your conformity assessment.

The Legal Framework for Designation

MDR Article 42 and Annex VII establish the designation framework. A conformity assessment body applies to the national competent authority in the EU member state where it is established. The competent authority evaluates the body's organizational structure, personnel qualifications, technical expertise, infrastructure, impartiality safeguards, and conflict-of-interest policies. The European Commission and representatives of other member states participate in a joint assessment, ensuring that designation standards are applied uniformly across the EU. If the body meets all requirements, the member state designates it, and the designation is recorded in the NANDO database.

This joint assessment process, absent under the MDD, is one of the reasons designation takes 18 to 24 months under the MDR. It is also the reason the number of designated bodies remains limited: the bar is higher, and the process is more thorough.

Scope of Designation: The Critical Detail

Each Notified Body's designation specifies:

Device types the body is authorized to assess (e.g., active implantable devices, non-active implantable devices, invasive devices, orthopedic devices, cardiovascular devices, IVD reagents)
Classification ranges (e.g., Class IIa, IIb, III)
Conformity assessment annexes the body can perform (e.g., Annex IX, Annex X, Annex XI Parts A and B)
Specific codes from the European Databank on Medical Devices nomenclature
Any restrictions or conditions on the designation

This scope is not abstract. If your device is a Class III active implantable pacemaker, the Notified Body you select must hold designation that specifically covers active implantable devices at the Class III level. A Notified Body designated only for Class IIa non-active devices cannot assess your product, regardless of how capable or available it may be.

The NANDO Information System

The NANDO (New Approach Notified and Designated Organizations) information system is the official EU database for verifying Notified Body designation status and scope. Maintained by the European Commission and publicly accessible online, NANDO is an essential tool for manufacturer research. It allows filtering by regulation (MDR or IVDR), member state, device type, and conformity assessment annex.

When using NANDO, pay close attention to the specific scope codes listed for each Notified Body. Two Notified Bodies may both be designated under the MDR, but one may cover implantable orthopedic devices while the other covers electromechanical patient monitoring equipment. The distinction matters.

When Classification Changes Affect Notified Body Scope

If your device is reclassified under the MDR to a higher risk class than it held under the MDD -- a common occurrence given the MDR's more conservative classification rules -- you must confirm that your current or prospective Notified Body holds designation for the new classification level. A manufacturer with a device that was Class IIb under the MDD but is now Class III under the MDR cannot rely on a Notified Body designated only for Class IIa and IIb devices. This scenario is one of the most common triggers for a Notified Body change.

How to Select a Notified Body: Detailed Criteria and Evaluation Process

Notified Body selection is a multi-factor decision that should be approached with the same discipline applied to any critical vendor qualification. The following criteria represent the factors that manufacturers should evaluate systematically.

1. Scope of Designation

This is the non-negotiable starting point. Verify in NANDO that the Notified Body holds designation for:

Your specific device type (using the relevant EUDAMED nomenclature codes)
Your device's classification level under MDR Annex VIII or IVDR classification rules
The conformity assessment annex applicable to your device class
Any specific regulatory pathways relevant to your device (e.g., the scrutiny procedure for Class III devices under Article 54)

If the Notified Body's scope does not cover your device, move on. There is no mechanism to obtain an exception.

2. Technical Expertise and Track Record

Beyond scope, evaluate whether the Notified Body has demonstrated expertise with devices similar to yours. This is a qualitative judgment, but an important one. Notified Bodies with deep experience in your device category will conduct more efficient reviews because their reviewers understand the technology, the risk profile, and the typical evidence pathways. A Notified Body encountering your device type for the first time may request additional information, extend review cycles, and ultimately take longer.

Ask potential Notified Bodies directly about their experience with devices in your category. Request information about the number of certificates they have issued for similar devices, the typical number of review cycles, and any specific challenges they have observed.

3. Capacity and Current Lead Times

In the 2026 market, this criterion may be the deciding factor. Contact potential Notified Bodies early and ask for current lead time estimates for new applications. Be specific: ask for the expected timeline from application submission to certification for a device in your classification and category. Some Notified Bodies maintain public dashboards or reports with current capacity metrics. Others will provide estimates on request.

When evaluating lead times, distinguish between:

Time to acknowledgment of application. How long before the Notified Body confirms receipt and assigns a project manager?
Time to first document review. When will technical documentation review begin?
Time to first audit. When can the initial QMS audit be scheduled?
Time to certificate issuance. What is the total elapsed time from application to certificate?

The total figure is what matters for your planning, but the intermediate milestones reveal where delays are concentrated.

4. Fee Structure and Pricing Transparency

Notified Body fees vary significantly and are not standardized. Most Notified Bodies charge based on a combination of:

Application fees (fixed, paid at submission)
Audit fees (daily rates for on-site or remote auditing, including auditor travel expenses)
Technical documentation review fees (per-device or per-file charges)
Surveillance fees (annual fees for ongoing surveillance audits)
Certificate issuance and renewal fees

Request a detailed fee proposal before committing. Understand what is included and what triggers additional charges (e.g., additional audit days due to nonconformities, supplementary reviews for design changes). Transparency in fee structures is itself a positive signal: Notified Bodies that provide clear, itemized pricing tend to be more professional in other aspects of the relationship as well.

5. Geographic Coverage and Language Capabilities

If your manufacturing sites are located in multiple countries, confirm that the Notified Body can conduct audits at all relevant locations. If your technical documentation is prepared in a language other than the Notified Body's working language, determine whether translation will be required and at whose expense. Language barriers can introduce delays, misinterpretation risks, and additional costs that compound over the life of the certification.

6. Communication Quality and Accessibility

The Notified Body relationship spans years, not months. After initial certification, you will interact with the Notified Body regularly for surveillance audits, design change notifications, periodic safety update report reviews, and certificate renewals. The quality and responsiveness of communication during the initial engagement phase is a reasonable proxy for the ongoing relationship.

Evaluate how quickly the Notified Body responds to inquiries, whether a dedicated contact person is assigned, whether communication is clear and constructive, and whether the body demonstrates a willingness to engage in pre-submission dialogue. Notified Bodies that are communicative and transparent during the selection phase tend to maintain those qualities throughout the certification lifecycle.

7. References and Industry Reputation

Contact other manufacturers in your industry sector -- through trade associations, professional networks, or industry events -- and ask about their experiences with specific Notified Bodies. No Notified Body is perfect, but patterns emerge: some are consistently described as thorough but fair, others as slow but methodical, and still others as unpredictable or difficult to work with.

Industry reputation is not a formal selection criterion, but it is a data point that can help differentiate between otherwise similar Notified Bodies. MedTech Europe and national trade associations sometimes publish position papers or surveys that include manufacturer feedback on Notified Body performance.

Structuring the Selection Process

A structured selection process should follow these steps:

Define your requirements. Document your device classification, applicable conformity assessment annex, timeline constraints, budget parameters, and any special requirements (multiple manufacturing sites, specific language needs, etc.).
Screen candidates using NANDO. Identify all Notified Bodies whose designation scope covers your device. Create a shortlist.
Issue a request for proposal or information. Send your requirements document to shortlisted Notified Bodies. Request detailed proposals including scope confirmation, timeline estimates, fee structures, and references.
Evaluate proposals against weighted criteria. Score each Notified Body against the criteria above, weighting each factor according to your priorities. If timeline is critical, weight capacity and lead times heavily. If cost is the primary constraint, weight fees more heavily.
Conduct interviews or pre-submission meetings. Meet with the top two or three candidates. Assess communication quality, technical understanding, and cultural fit. This is also the opportunity to clarify any ambiguities in their proposals.
Check references. Contact manufacturers who have certified similar devices with the Notified Body. Ask about timeline adherence, communication quality, fairness of findings, and responsiveness to questions.
Make a decision and begin the application process promptly. In the 2026 market, delays in application submission translate directly to delays in certification.

The Conformity Assessment Routes: Which Pathway Applies to Your Device

The conformity assessment procedure your device must follow is determined by its classification under MDR Annex VIII. The MDR provides several assessment annexes, and the applicable routes differ by device class. Understanding which route applies to your device is essential before engaging a Notified Body, because the route determines the scope of assessment, the documentation requirements, the audit structure, and the timeline.

Full Quality Assurance System (Annex IX)

This is the most commonly used conformity assessment route and is available for all device classes that require Notified Body involvement. Under Annex IX, the Notified Body assesses both the manufacturer's quality management system (Chapter I) and the technical documentation for representative devices (Chapter II), with ongoing surveillance under Chapter III.

Annex IX is the default route for most manufacturers because it provides a single, integrated assessment framework. The Notified Body issues a single EU quality management system certificate that covers the QMS and the assessed device types.

EU Type Examination Plus Quality Assurance (Annex X + Annex XI Part A)

This two-part route is available as an alternative to Annex IX for Class IIb and Class III devices. Under Annex X, the Notified Body conducts an EU type examination -- a review of the device's design and technical documentation to verify conformity with the MDR's General Safety and Performance Requirements. Under Annex XI Part A, the Notified Body assesses the manufacturer's production quality assurance system.

The Annex X + XI Part A route separates the design assessment from the production assessment, which can be advantageous for manufacturers who produce at multiple sites or who want to decouple design approval from ongoing production quality verification. It also results in two certificates: an EU type-examination certificate and an EU product quality assurance certificate.

Product Quality Assurance (Annex XI Part A)

For Class IIa and certain Class IIb devices, Annex XI Part A may be used as a standalone or combined route. The focus is on the manufacturer's production quality assurance system, with the Notified Body verifying that the production processes consistently produce devices that meet the approved design specifications.

Choosing the Right Route

For most manufacturers, the decision is straightforward. Annex IX is the standard route and is understood by all designated Notified Bodies. The Annex X + XI Part A route is useful in specific circumstances:

The manufacturer produces the same device type at multiple manufacturing sites and wants to centralize design approval while distributing production assessments
The manufacturer's design processes and production processes are managed by different organizational units with distinct quality systems
The manufacturer has existing type examination certificates under the MDD that it wants to transition to MDR type examination certificates without a full QMS reassessment

Discuss the route selection with your prospective Notified Body during the pre-application phase. Some Notified Bodies have preferences or greater experience with specific routes, and their input can help you make the right choice.

The Scrutiny Procedure (Article 54)

For Class III and certain Class IIb implantable devices, the MDR introduces an additional layer: the clinical evaluation consultation procedure, commonly known as the scrutiny procedure. Under Article 54, the Notified Body must consult an expert panel before issuing a certificate for certain high-risk devices. The expert panel reviews the Notified Body's clinical evaluation assessment report and may provide an opinion that the Notified Body must "duly consider" -- meaning it carries significant weight.

The scrutiny procedure adds time to the certification process, typically 60 to 120 days, depending on whether the expert panel identifies concerns. Manufacturers of Class III and implantable devices should factor this additional time into their planning.

Timeline Expectations: Realistic Planning for 2026-2027

Understanding the typical timeline for Notified Body engagement is essential for regulatory planning. The following timeline reflects current market conditions in 2026 and assumes a manufacturer pursuing certification under Annex IX for a Class IIa or IIb device with no major nonconformities.

Phase	Duration	Description
Initial inquiry and scope confirmation	2-4 weeks	Manufacturer contacts NB, confirms scope coverage, receives preliminary information
Quote and contract negotiation	4-8 weeks	NB reviews application documents, provides fee proposal, parties negotiate and sign agreement
Stage 1 audit (documentation review)	2-4 months	NB reviews QMS documentation, technical documentation structure, identifies gaps
Stage 2 audit (on-site or remote)	3-6 months after Stage 1	Full QMS audit at manufacturing site(s), process observations, interviews
Technical documentation review	6-12 months (parallel with audits)	NB reviews technical files for representative devices, may request additional information
Nonconformity resolution	2-6 months	Manufacturer addresses findings, submits corrective actions, NB verifies closures
Certificate issuance	2-4 weeks after successful completion	NB issues EU quality management system certificate
Total (typical)	13-18 months	From signed agreement to issued certificate

Factors That Extend Timelines

Several factors can push the total timeline beyond 18 months:

Major nonconformities. If the audit or documentation review reveals significant gaps in the QMS or technical files, resolving them can add months. A single major nonconformity in clinical evidence, for example, may require the manufacturer to conduct additional literature searches, update the clinical evaluation report, and potentially initiate post-market clinical follow-up activities -- all before the Notified Body will close the finding.
Complex device types. Implantable devices, combination products, devices incorporating medicinal substances, and software as a medical device typically face longer review cycles because the technical documentation is more extensive and the clinical evidence requirements are more demanding.
Scrutiny procedure. Devices subject to Article 54 scrutiny face an additional 60 to 120 days for expert panel consultation.
Notified Body capacity. If the Notified Body is experiencing a surge in applications -- which many are in 2026 -- internal review queues may extend timelines regardless of the manufacturer's readiness.
Multiple manufacturing sites. Devices manufactured across multiple sites require audits at each location, which complicates scheduling and extends the audit phase.

Planning Recommendations

For manufacturers targeting the December 31, 2027 deadline for Class III devices or the December 31, 2028 deadline for Class IIa/IIb devices, the planning arithmetic is stark. Count backward from the deadline:

Class III (December 2027): Certificate needed by approximately June 2027 to allow time for CE marking updates, EUDAMED registration, and any market transition activities. With a 15-18 month assessment timeline, the application should be submitted by approximately December 2025 to March 2026.
Class IIa/IIb (December 2028): Certificate needed by approximately June 2028. With a 13-18 month assessment timeline, the application should be submitted by approximately December 2026 to June 2027.

Manufacturers who have not yet submitted applications for devices with a 2027 deadline should treat the situation with urgency. Those targeting the 2028 deadline have somewhat more runway, but should not assume that Notified Body capacity will improve -- demand is expected to increase as the deadline approaches.

Changing Notified Bodies: When and How to Transfer

Circumstances arise that require a manufacturer to change Notified Bodies. The most common triggers include:

The current Notified Body withdraws from MDR designation or has its designation restricted
The current Notified Body's scope no longer covers the manufacturer's devices (e.g., due to reclassification)
Persistent quality or communication problems with the current Notified Body
Unsustainable lead times or capacity constraints
A merger or acquisition that brings the manufacturer's devices under a different organizational structure
Geographic expansion that requires a Notified Body with broader coverage

MDR Article 43 permits manufacturers to change Notified Bodies, but the process is not simple and requires careful planning to avoid gaps in certification.

Legal Requirements for Notified Body Change

Under MDR Article 43:

The manufacturer must submit a new application to the prospective Notified Body
The new Notified Body must perform a conformity assessment in accordance with the applicable annex -- this is not a paperwork transfer
The manufacturer must inform the competent authority of the member state where the device is registered of the change
The old Notified Body is required to cooperate with the transfer of relevant documentation to the new Notified Body
There must be no gap in conformity assessment coverage -- at any point where the device is on the market, it must be covered by a valid certificate or a valid transition arrangement

The Transfer Process in Practice

A Notified Body transfer typically follows these phases:

Phase 1: Preparation (2-4 months)

Identify the reasons for the change and document them. Research potential replacement Notified Bodies using NANDO and the selection criteria described in this guide. Issue requests for proposal to shortlisted candidates. Evaluate proposals and select the new Notified Body.

Phase 2: Application and Contract (2-3 months)

Submit a formal application to the new Notified Body, including technical documentation, current QMS certification status, existing certificates, and a summary of any outstanding nonconformities or open findings from the current Notified Body. Negotiate and sign the conformity assessment agreement.

Phase 3: Assessment by the New Notified Body (6-12 months)

The new Notified Body must perform its own conformity assessment. This does not mean starting from zero -- the manufacturer's existing technical documentation, QMS certification, and compliance history provide a foundation -- but the new Notified Body must independently verify conformity. The assessment typically includes:

Review of the technical documentation for all devices covered by the transfer
A QMS audit (which may be abbreviated if the manufacturer holds a current ISO 13485 certificate from a reputable certification body, but the Notified Body must still conduct its own assessment)
Review of post-market surveillance data, vigilance history, and any open corrective actions
Verification that the manufacturer's QMS meets the specific MDR requirements, not just ISO 13485

Phase 4: Transition and Certificate Issuance (2-4 months)

Once the new Notified Body completes its assessment and is satisfied, it issues new certificates. The timing of the transition must be coordinated so that the new certificates take effect before or simultaneously with the expiration or withdrawal of the old certificates. The manufacturer must update EUDAMED records, CE marking documentation, and any labeling that references the old Notified Body number.

Phase 5: Notification and Record Updates (1-2 months)

Inform the competent authority of the change. Update EUDAMED. Update the EU Declaration of Conformity to reference the new Notified Body. Notify authorized representatives, distributors, and importers as appropriate.

Total Transfer Timeline

A Notified Body transfer typically takes 12 to 18 months from the decision to change to the issuance of new certificates. This timeline mirrors the initial certification timeline because the new Notified Body must conduct a full assessment, even when the manufacturer has an established compliance history.

Critical Planning Principles for Transfers

Start early. Begin the transfer process at least 12 to 18 months before the current certificate expires. If the current Notified Body has signaled financial difficulties, staffing problems, or potential withdrawal from designation, start even earlier.

Maintain the current certification during the transfer. Do not allow the current certificate to lapse before the new certificate is in hand. This may require continuing surveillance audits and paying fees to the current Notified Body during the transfer process, which is an unwelcome additional cost but a necessary one.

Document everything. The new Notified Body will need access to technical documentation, audit reports, nonconformity records, corrective action histories, post-market surveillance data, and any correspondence with the old Notified Body related to the devices being transferred. Ensure that your document management system can provide this information promptly.

Coordinate the overlap. There will be a period during which you are engaged with both the old and new Notified Bodies simultaneously. Plan the resource allocation for this overlap period -- you will need regulatory affairs and quality personnel to support both the ongoing surveillance relationship with the current NB and the application process with the new NB.

The 2026 Implementing Regulation: Standardizing Notified Body Procedures

On December 12, 2025, the European Commission published a draft implementing regulation establishing uniform administrative and technical requirements for Notified Bodies under the MDR and IVDR. This regulation represents the most significant intervention in Notified Body standardization since the MDR came into force.

What the Implementing Regulation Addresses

The regulation standardizes quality management and procedural protocols for Notified Bodies, addressing a long-standing complaint from manufacturers: that different Notified Bodies apply different timelines, procedures, and evidentiary standards, creating unpredictability and inconsistency. The key provisions include:

Proposed review clocks. Mandatory maximum timelines for Notified Body activities, including 60 days for initial document review. Different clocks apply to initial certification versus changes, with defined "clock-stops" for periods when the manufacturer is preparing responses.
Certificate issuance timelines. 15 days for a Notified Body to issue a renewed certificate after a successful reassessment, provided no material changes have occurred.
Standardized procedural requirements. Uniform requirements for how Notified Bodies handle applications, conduct assessments, manage nonconformities, and communicate with manufacturers.
Quality management requirements for Notified Bodies themselves. The regulation specifies the internal QMS standards that Notified Bodies must maintain, including document control, personnel management, and record keeping.

Industry Reaction

The reaction from Notified Bodies has been mixed. Team-NB, the European association of Notified Bodies for medical devices, has expressed concerns that the proposed timelines -- particularly the 60-day review clock -- are unrealistic given current staffing levels and the complexity of MDR assessments. They have argued that the regulation does not address the fundamental capacity problem and risks creating a framework where Notified Bodies are held to deadlines they cannot meet without compromising assessment quality.

MedTech Europe, the European trade association for the medical technology industry, has taken a more supportive position. In February 2026, MedTech Europe described the implementing act as a "pragmatic first step to restore predictability" in the Notified Body process, while calling for more fundamental reforms to address capacity constraints.

The consultation period on the draft regulation ended January 23, 2026. The regulation is expected to be adopted in early 2026 after the European Commission considers feedback and potentially modifies the timelines. If adopted in its current or near-current form, it could materially improve predictability for manufacturers by establishing enforceable timelines and standardized procedures.

What This Means for Manufacturers

If the implementing regulation is adopted, manufacturers should expect:

More predictable timelines for Notified Body review stages, making project planning more reliable
Standardized communication formats and requirements, reducing the variation between Notified Bodies
Potentially faster turnaround on certificate renewals and routine assessments
The possibility that some Notified Bodies will initially struggle to meet the mandated timelines, particularly those already operating at capacity

Manufacturers should monitor the adoption status of this regulation closely. If it enters into force, update your regulatory project plans to reflect the standardized timelines and adjust expectations accordingly.

MDR Targeted Revisions: How Certificate Management Is Evolving

On December 16, 2025, the European Commission released its targeted revision of the MDR (document COM(2025)1023 final, spanning approximately 170 pages). This revision package proposes several changes that will directly affect how manufacturers interact with Notified Bodies and manage certificates.

End of Fixed Five-Year Certificate Validity

Under the current MDR, Notified Body certificates are valid for a maximum of five years, after which a full reassessment is required. The targeted revision proposes replacing this fixed validity period with an ongoing system of periodic reviews that are proportionate to device risk. Under the proposed framework:

Lower-risk devices (Class IIa) would face less frequent and less intensive periodic reviews
Higher-risk devices (Class III, implantable) would continue to face rigorous periodic assessments
The binary nature of certificate expiration -- where a certificate is valid for five years and then expires if not renewed -- would be replaced by a continuous compliance framework

This change, if adopted, would reduce the administrative burden of certificate renewals for lower-risk devices and allow Notified Bodies to allocate their limited resources toward higher-risk products that warrant greater scrutiny.

Predetermined Change Control Plans

The revision introduces the concept of predetermined change control plans agreed between the manufacturer and the Notified Body. Under this framework, manufacturers and Notified Bodies would agree in advance on which types of device changes can be implemented without prior Notified Body approval, which require notification, and which require a formal supplementary assessment. This is intended to streamline the management of device modifications and reduce the time Notified Bodies spend reviewing minor changes.

Risk-Based Surveillance

The revision proposes a shift toward risk-based surveillance, where the intensity and frequency of Notified Body oversight are calibrated to the risk profile of the device. This could mean less frequent on-site audits for manufacturers of lower-risk devices with strong compliance histories, and more intensive surveillance for higher-risk devices or manufacturers with compliance concerns.

Projected Cost Savings and Industry Debate

The European Commission has projected that the targeted revisions could generate industry cost savings of approximately 3.3 billion euros per year. This figure has been disputed by Team-NB, which argues that the savings are overstated and that the revisions do not adequately account for the costs of implementing the new framework.

Regardless of the precise savings figure, the direction of travel is clear: the Commission wants to make the MDR system more proportionate, more efficient, and less burdensome for both manufacturers and Notified Bodies, while maintaining -- or in some cases strengthening -- the safety and performance standards that motivated the MDR in the first place.

Timeline for Adoption

The targeted revision was released in December 2025 and will need to work its way through the European Parliament and Council. Realistically, adoption is not expected before late 2026 or early 2027, with implementation following after a transition period. Manufacturers should track the legislative progress but should not make current plans contingent on these changes being in force.

EUDAMED and Notified Body Transparency: Mandatory Registration from May 2026

The EUDAMED database has been under development since the MDR was adopted in 2017. As of May 28, 2026, the Notified Body module of EUDAMED becomes mandatory, with significant implications for manufacturers and Notified Bodies alike.

What Mandatory EUDAMED Registration Means for Notified Body Certificates

After May 28, 2026, all Notified Body certificates issued under the MDR and IVDR must be registered in EUDAMED. This includes new certificates, renewed certificates, and any changes to existing certificates (restrictions, suspensions, withdrawals). The registration requirement creates a real-time, centralized record of every Notified Body certificate in the EU medical device ecosystem.

Transparency Implications

Mandatory EUDAMED registration will increase transparency in several ways:

Certificate verification. Competent authorities, other Notified Bodies, and eventually the public will be able to verify the status of any Notified Body certificate. This makes it harder for manufacturers to claim certification that has expired, been suspended, or been withdrawn.
Cross-referencing device data. EUDAMED will cross-reference device registration data against Notified Body certificates, enabling automated checks that a device listed on the market is actually covered by a valid certificate.
Notified Body capacity visibility. The aggregated certificate data in EUDAMED will provide a clearer picture of each Notified Body's active portfolio, which may inform manufacturer selection decisions and competent authority oversight.

What Manufacturers Should Do

Before May 28, 2026:

Confirm that your Notified Body is prepared to register your certificates in EUDAMED. Most designated Notified Bodies have been preparing for this requirement, but verify rather than assume.
Ensure your Actor registration in EUDAMED is complete and accurate. Manufacturers must be registered as economic operators before certificates can be linked to their devices.
Verify that the device data in EUDAMED (UDI-DI records, Basic UDI-DI records) is consistent with the information in your Notified Body certificates. Discrepancies between EUDAMED device records and certificate data will create compliance problems.

After May 28, 2026:

Treat EUDAMED certificate registration as a compliance checkpoint. When your Notified Body issues a new certificate or renews an existing one, confirm that it has been registered in EUDAMED within the required timeframe.
If you change Notified Bodies, ensure that the transition is reflected accurately in EUDAMED -- old certificates are marked as superseded or withdrawn, and new certificates are properly linked to the relevant device records.

Practical Recommendations for Manufacturers in 2026

The regulatory environment for Notified Body engagement in 2026 is characterized by constrained capacity, evolving rules, and pressing deadlines. The following recommendations are actionable steps that manufacturers should take now.

For Manufacturers Selecting a Notified Body

Submit applications to multiple Notified Bodies simultaneously. There is no regulatory prohibition on submitting applications to more than one Notified Body, provided you ultimately sign a conformity assessment agreement with only one. In a market where some Notified Bodies have waiting lists, submitting to two or three candidates -- and proceeding with whichever can offer the earliest timeline -- is a pragmatic strategy.

Prioritize timeline over price. In the current market, the cost difference between Notified Bodies is less significant than the timeline difference. A Notified Body that is 20 percent more expensive but can begin your assessment six months sooner is likely the better choice, given the regulatory deadlines approaching in 2027 and 2028.

Engage in pre-submission dialogue. Most Notified Bodies offer pre-submission meetings or consultations. Use these to confirm scope coverage, understand documentation expectations, identify potential issues early, and establish a working relationship before the formal assessment begins.

Prepare your documentation to MDR standards before submitting. The most common cause of extended timelines is incomplete or inadequate technical documentation. Invest in thorough clinical evaluation reports, comprehensive risk management files, and complete post-market surveillance documentation before you submit. A well-prepared submission reduces the number of review cycles and shortens the overall timeline.

Do not wait for regulatory reforms. The implementing regulation and targeted revisions described in this guide may improve the system over time, but they are not yet in force and should not be factored into current planning. Submit your application under the current rules and adjust if reforms take effect.

For Manufacturers Considering a Notified Body Change

Assess whether a change is truly necessary. A Notified Body change is a significant undertaking that consumes regulatory and quality resources for 12 to 18 months. Before initiating a transfer, confirm that the problems with the current Notified Body are systemic and unlikely to improve, rather than temporary issues related to staffing, scheduling, or specific reviewer dynamics.

Begin the transfer at least 12 to 18 months before your current certificate expires. This is the minimum lead time. If your certificate expires in December 2027, you should be initiating the transfer process by mid-2026 at the latest.

Maintain full compliance with the current Notified Body during the transfer. Continue surveillance audits, submit required documentation, and pay required fees. A lapse in your current certification during the transfer creates a gap in market access that cannot be retroactively filled.

Coordinate the transition timeline carefully. The goal is for the new Notified Body's certificate to take effect before the old certificate expires or is surrendered. This requires close coordination between the manufacturer, the old Notified Body, and the new Notified Body.

Document the transfer rationale and process. Competent authorities may ask about the reason for the change. Maintain clear records of the decision-making process, the timeline, and the steps taken to ensure continuity of certification.

For All Manufacturers

Monitor the NANDO database regularly. Notified Body designation scopes change. A Notified Body that covers your device type today may have its scope restricted tomorrow. Check NANDO periodically to confirm that your Notified Body's designation remains valid for your devices.

Prepare for EUDAMED mandatory registration by May 28, 2026. Ensure your actor registration is complete, your UDI-DI records are accurate, and your Notified Body is prepared to register your certificates.

Track the implementing regulation and targeted MDR revisions. These regulatory changes have the potential to improve predictability, reduce administrative burden, and reshape certificate management. Stay informed through the European Commission's health policy updates, MedTech Europe communications, and your Notified Body's own guidance.

Build regulatory resilience. The current Notified Body market is volatile. Notified Bodies can lose designation, restrict their scope, or experience capacity crises. Maintain your technical documentation in a state of continuous readiness, ensure your QMS is robust and audit-ready at all times, and cultivate relationships with more than one Notified Body so that you have options if circumstances change.

Invest in internal regulatory capability. Manufacturers who rely entirely on external consultants for Notified Body management are at a disadvantage in the current environment. The ability to prepare high-quality technical documentation, manage the audit process, respond to nonconformities, and coordinate EUDAMED registration internally -- or through a trusted regulatory affairs partner with deep expertise -- is a competitive advantage that directly translates to faster certification timelines.

The European medical device regulatory landscape in 2026 is demanding, but it is navigable for manufacturers who approach Notified Body selection and management with the rigor, preparation, and strategic thinking that the current environment requires.