MDR Article 52 · IVDR Article 48
Do I need a Notified Body?
The answer is usually one classification decision away.
Risk class opens the door, but sterile condition, measuring function, reuse and special pathways can change who must walk through it. Use the route checker, then see what the answer means in practice.
Check your route ↓Which Regulation?
MDR or IVDRWhich class?
I–III or A–DAny modifier?
Sterile · measuring · reusableManufacturer conformity assessment
Notified Body for defined aspects
Notified Body conformity assessment
The 30-second answer
Two narrow self-declaration lanes. Everything else turns toward a Notified Body.
Under the MDR, a standard Class I device can normally be self-declared. Class Is, Im and Ir devices need limited Notified Body involvement, while Classes IIa, IIb and III require Notified Body conformity assessment.
Under the IVDR, Class A devices can normally be self-declared. Class A sterile devices need limited Notified Body involvement, while Classes B, C and D require Notified Body conformity assessment.
Freeze the intended purpose, qualification and classification first. Otherwise, the price and timeline may describe the wrong regulatory route.
Interactive route checker
Choose the product family, then choose the class
This tool describes the ordinary route for a new device. Transitional devices and special pathways need a separate status review.
Select the MDR class or modifier
ResultSelf-declaration route
No Notified Body for the pre-market conformity assessment
The manufacturer draws up the technical documentation, performs the conformity assessment, issues the EU declaration of conformity and affixes the CE marking.
- Classification must be documented and defensible
- All applicable MDR obligations still apply
- Self-declaration is not an exemption from evidence, QMS or PMS
ResultLimited Notified Body scope
Yes, for the sterility aspects
The Notified Body involvement is limited to establishing, securing and maintaining sterile conditions. The rest of the Class I conformity assessment remains the manufacturer’s responsibility.
- Sterilisation validation and controls matter
- The QMS audit scope is correspondingly limited
- The certificate does not transfer product responsibility
ResultLimited Notified Body scope
Yes, for the metrological requirements
The Notified Body involvement is limited to the aspects concerning conformity with the measurement requirements. The manufacturer remains responsible for the complete MDR file.
- Define the measuring function precisely
- Validate accuracy, precision and claimed range
- Keep metrological controls traceable through production
ResultLimited Notified Body scope
Yes, for the aspects relating to reuse
The assessment focuses on cleaning, disinfection, sterilisation, maintenance, functional testing and the related instructions for use.
- Validate the complete reprocessing cycle
- Define the usable life and acceptance criteria
- Make the reuse instructions operational and testable
ResultNotified Body required
Yes, Class IIa requires conformity assessment by a Notified Body
The route normally combines QMS assessment with technical-documentation assessment for at least one representative device per category, or uses an applicable Annex XI alternative.
- Prepare the QMS and technical file as one system
- Define the device category and sampling rationale
- Plan clinical evidence and PMS before submission
ResultNotified Body required
Yes, Class IIb requires conformity assessment by a Notified Body
The ordinary Annex IX route includes QMS assessment and technical-documentation assessment for representative devices. Implantable Class IIb devices can be subject to device-by-device technical-documentation assessment, with specified exceptions.
- Confirm whether the device is implantable
- Map the chosen route to Annex IX or Annex X plus XI
- Expect closer scrutiny of clinical evidence and PMCF
ResultNotified Body required
Yes, Class III follows the highest-scrutiny route
The manufacturer uses Annex IX or Annex X coupled with Annex XI. Device-specific technical-documentation assessment and additional procedures may apply.
- Treat clinical strategy as an early design input
- Resolve consultation and implantable-device questions
- Build time for questions, sampling and certification decisions
Select the IVDR class or modifier
ResultSelf-declaration route
No Notified Body for the pre-market conformity assessment
The manufacturer prepares the technical documentation, declares conformity and affixes the CE marking after demonstrating compliance with the IVDR.
- Classification under Annex VIII remains essential
- Performance evaluation and PMS are still required
- Sterile Class A devices leave this self-declaration lane
ResultLimited Notified Body scope
Yes, for establishing, securing and maintaining sterile conditions
The product remains Class A, but sterile placement on the market triggers a limited Notified Body assessment under the current IVDR route.
- Document the sterile barrier and sterilisation process
- Validate maintenance of sterility through shelf life
- Keep the wider performance file under manufacturer control
ResultNotified Body required
Yes, Class B requires Notified Body conformity assessment
The ordinary route includes QMS assessment and assessment of technical documentation for at least one representative device per category.
- Define the device category coherently
- Integrate scientific validity and performance evidence
- Address self-testing or near-patient testing where applicable
ResultNotified Body required
Yes, Class C requires Notified Body conformity assessment
The Annex IX route includes QMS assessment and technical-documentation assessment for at least one representative device per generic device group. Annex X plus XI is an alternative route.
- Confirm the generic device group
- Prepare the performance evaluation for technical review
- Identify companion-diagnostic or testing-setting procedures
ResultNotified Body required
Yes, Class D follows the highest-scrutiny IVDR route
The route includes device-specific technical-documentation assessment. EU reference laboratory verification and, in defined circumstances, expert consultation can add further layers.
- Confirm whether an EU reference laboratory is designated
- Plan reference materials and performance claims early
- Allow for every external step in the certification timeline
Choose the situation that changes the ordinary class table
These routes cannot be reduced to a universal yes or no without more facts.
Custom-made medical device
Custom-made devices follow MDR Annex XIII rather than the ordinary CE-marking route. Class III custom-made implantable devices additionally require the conformity assessment specified in MDR Article 52(8).
Check device type and classHealth-institution in-house device
Qualifying in-house devices may rely on MDR or IVDR Article 5(5) rather than ordinary market placement. Every condition of that exemption must be met and national rules can add requirements.
Check every Article 5(5) conditionSystem or procedure pack
MDR Article 22 creates its own obligations. A person sterilising compliant systems or procedure packs for market placement must use a Notified Body for the aspects related to sterility.
Check components, compatibility and sterilisationInvestigational or performance-study device
A device used only in an MDR clinical investigation or IVDR performance study follows the applicable study provisions, not the ordinary commercial CE-marking route described above.
Check the study pathwayLegacy or transitional device
Extended transition periods do not turn a legacy device into a simple self-declared product. Certificate, application, agreement, surveillance and no-significant-change conditions need a dedicated assessment.
Check status and datesBorderline or combined product
Medicinal substances, human or animal tissues, machinery functions or uncertain qualification can trigger consultations or another legal framework. Resolve qualification before choosing an assessment body.
Check the regulatory identity firstImportantThis orientation tool cannot classify a product from its name alone. Intended purpose, users, patient population, operating principle, claims and foreseeable consequences of failure determine the route.
The complete map
A class table with the exceptions kept visible
The key is not simply low risk versus high risk. A modifier can create a defined third-party role without changing the underlying class.
Manufacturer route
Non-sterile, no measuring function and not a reusable surgical instrument.
No pre-market NBLimited NB route
Sterility, metrology or defined reuse aspects enter the assessment scope.
NB for specified aspectsNotified Body route
QMS and technical-documentation assessment follow the applicable Annex IX–XI route.
NB requiredManufacturer route
Class A device not placed on the market in sterile condition.
No pre-market NBLimited NB route
The assessment is limited to establishing, securing and maintaining sterile conditions.
NB for sterilityNotified Body route
QMS and technical-documentation assessment increase with class and device characteristics.
NB requiredWhat the answer changes
A Notified Body does not take ownership of conformity
It performs the third-party tasks assigned by the chosen conformity-assessment route. The manufacturer still owns the device, the claims, the evidence, the quality system and the continuing decision that the product conforms.
The certificate supports the manufacturer’s conformity assessment. The manufacturer issues the EU declaration of conformity and affixes the CE marking.
Quality management system
Audit of the organisation, processes, responsibilities, suppliers, production controls and lifecycle activities within the applicable scope.
Technical documentation
Assessment of device description, design, verification and validation, risk management, clinical or performance evidence, labelling and PMS documentation.
Additional procedures
Depending on the product, consultations, laboratory verification, sampling or device-specific assessment may extend beyond the core route.
Surveillance and changes
Certification starts an ongoing relationship involving surveillance, significant changes, certificate maintenance and continued regulatory oversight.
The Class I trap
Limited scope does not mean a lighter manufacturer file
The Notified Body looks at only the specified aspect, but the manufacturer must still demonstrate conformity of the complete device.
Can sterility be established and maintained?
Expect focus on sterilisation validation, bioburden and environmental controls, sterile barrier integrity, shelf life, outsourced processes and release controls.
Can the measurement be trusted?
Expect focus on metrological performance, calibration, traceability, tolerances, production controls and the consistency of measurement claims and labelling.
Can safe performance survive reuse?
Expect focus on cleaning, disinfection, sterilisation, maintenance, functional testing, use-life limitations and validated reprocessing instructions.
Can sterile condition remain controlled?
Expect focus on establishing, securing and maintaining sterility while the scientific-validity and performance file remains part of the manufacturer’s complete IVDR demonstration.
Selection is a scope exercise
The right Notified Body is the one legally and technically able to assess your device
Reputation matters, but designation, competence, capacity and a workable long-term relationship matter first.
- 01Regulation
Check MDR or IVDR designation
A body designated under one Regulation is not automatically designated under the other.
- 02Scope
Match the designation codes
Compare the device technology, intended purpose and special features with the body’s current NANDO scope and limitations.
- 03Competence
Test real product experience
Ask how the body allocates clinical, software, cybersecurity, sterilisation, biological or IVD expertise relevant to the file.
- 04Route
Confirm the application architecture
Align device groups, Basic UDI-DIs, sites, critical suppliers, certificates and the requested conformity-assessment route.
- 05Capacity
Make the timeline testable
Separate application acceptance, audit availability, technical review, questions, closure and certification instead of relying on one headline estimate.
- 06Lifecycle
Look beyond the first certificate
Understand surveillance, change notification, additional reviews, certificate transfer, fees and communication after market entry.
Verify designation before commercial comparison
The European Commission’s NANDO system is the authoritative starting point for the current designation and scope. A company website or sales presentation is not a substitute.
Open NANDO ↗Before the application
Six answers that should already be stable
A premature application can lock the project into avoidable clarification cycles, scope changes and new quotations.
What exactly is the intended purpose?
Medical purpose, users, patients, use environment, indications, contraindications and operating principle.
Why is it a device or IVD?
Qualification rationale, mode of action, specimen relationship and any borderline considerations.
Which rule produces the class?
Every applicable classification rule, the decisive rule and the rationale for special modifiers.
What belongs in the application?
Device families, groups, Basic UDI-DIs, variants, accessories, sites and critical suppliers.
Where is the evidence risk?
Clinical or performance gaps, novel technology, cybersecurity, biocompatibility, sterilisation and unresolved standards.
Which conformity route fits?
Annex route, QMS scope, technical-documentation sampling and any product-specific additional procedure.
Expensive shortcuts
Seven ways the simple question becomes a long delay
Most delays begin before the Notified Body sees the file. They begin when product identity and submission scope remain fluid.
- 01
Treating every Class I device as self-declared and overlooking Is, Im or Ir status.
- 02
Assuming the Notified Body will select the classification rule and design the compliance strategy.
- 03
Choosing a body from brand recognition without checking the precise NANDO designation scope.
- 04
Requesting a quotation while intended purpose, variants, sites or device groups are still changing.
- 05
Believing an ISO 13485 certificate replaces MDR or IVDR conformity assessment.
- 06
Planning only for the initial audit and forgetting technical review, questions, closure and surveillance.
- 07
Applying the ordinary class table to a legacy, custom-made, in-house or study device without checking its special route.
Practical questions
Notified Body FAQ
Open the question that changes the next step in your project.
Can a standard Class I medical device be self-declared?+
Yes, provided it is genuinely Class I and is not placed on the market in sterile condition, does not have a measuring function and is not a reusable surgical instrument. The manufacturer still has to satisfy all applicable MDR requirements, prepare the technical documentation, operate the required quality management processes, perform clinical evaluation and PMS, issue the EU declaration of conformity and register as required.
Does the Notified Body determine my device classification?+
The manufacturer is responsible for classifying the device from its intended purpose and the applicable rules. When a Notified Body is involved, it reviews the classification and may challenge it. A disagreement is not solved by simply choosing another body; the competent-authority procedure in the Regulation may become relevant.
Does ISO 13485 certification remove the need for a Notified Body?+
No. ISO 13485 certification and regulatory conformity assessment are not interchangeable. If the MDR or IVDR requires Notified Body involvement, a separate ISO certificate does not replace it. Conversely, a self-declared device still needs an effective regulatory quality management system even though no Notified Body performs the pre-market conformity assessment.
Does every medical device software product require a Notified Body?+
No, but many medical software products are Class IIa or higher under MDR Rule 11 and therefore do. Software that is correctly classified as standard Class I may follow self-declaration. The intended purpose, significance of the information and possible impact of an incorrect decision must be assessed before deciding.
Is limited-scope involvement for Class Is, Im or Ir optional?+
No. The involvement is mandatory, but its scope is limited. For Class Is it concerns sterility, for Class Im the metrological requirements, and for Class Ir the aspects connected with reuse, including cleaning, disinfection, sterilisation, maintenance, functional testing and the related instructions.
Can any medical-device Notified Body assess my product?+
No. The body must be designated under the applicable Regulation and for conformity-assessment activities covering the relevant types of devices. Check its current NANDO entry, designation codes, limitations and product competence before treating it as a viable candidate.
Can a Notified Body design my compliance strategy?+
A Notified Body must preserve independence and impartiality. It can explain its application process and expectations, but it cannot become the consultant that creates the system it will later assess. The manufacturer should develop and defend its own regulatory strategy and documentation.
Do transitional or legacy devices follow this simple class table?+
Not always. Transitional provisions can affect deadlines, certificate status, surveillance arrangements and the timing of an MDR or IVDR application. The decision tool on this page describes the ordinary route for a new device; legacy status should be analysed separately against the current transitional conditions.
Primary regulatory sources
Check the legal route against the current source
Classification guidance supports application of the Regulations but does not replace the legal text or a product-specific assessment.
Regulation (EU) 2017/745
Articles 51–53 and Annexes VIII–XI
Regulation (EU) 2017/746
Articles 47–49 and Annexes VIII–XI
European Commission
Notified Bodies, designation and current resources
NANDO
Current designation and scope information
Medical-device classification
European Commission classification overview
MDCG guidance index
Current classification and conformity-assessment guidance
Make the first submission the right submission
Need to confirm the class, route and Notified Body scope?
MDRC can document the classification rationale, map the conformity-assessment route, identify suitable Notified Bodies and prepare the QMS and technical documentation for assessment.
