Product boundary · Risk class · Regulatory route
The right classification turns uncertainty into a workable market route
MDRC determines and documents the classification of medical devices, IVDs, software and accessories for selected markets—and translates the result into its conformity-assessment or submission consequences.
Intended purpose
Technology and use
Risk and impact
Target jurisdiction
Class · rule · rationale · regulatory pathway
The classification question
A class number is the conclusion, not the analysis
Classification must start with a controlled product definition. Small changes in intended purpose, duration, invasiveness, software function or the population affected can change the rule, class and route.
Product boundary
Determine what is being classified, including variants, configurations, accessories, software modules and combination elements.
Intended purpose
Control indications, users, patient or specimen population, use environment, operating principle and claimed clinical role.
Rule logic
Apply every potentially relevant rule, definition, implementing measure, special provision and market-specific interpretation.
Route consequences
Translate the conclusion into external review, QMS, evidence, submission, registration and post-market implications.
Commercial deliverable
Receive a position your team can use and defend
The output is proportionate to the decision. It can range from a focused classification opinion to a multi-market assessment covering a family of devices, variants, accessories and software functions.
Define the review scopeControlled product profile
The exact product facts and assumptions on which the conclusion depends.
Classification conclusion
The market-specific class, applicable rule or regulatory provision.
Documented rationale
A traceable explanation of the rules considered, selected and excluded.
Route implications
Expected review pathway, QMS, evidence, submission and surveillance impact.
Variants and accessories
A determination of what can share one rationale and what requires separate analysis.
Open-question register
Uncertainties, required evidence and any recommended authority or notified-body interaction.
Working method
Build the conclusion from product facts, not from resemblance
-
01
Frame
Define the decision and markets
Confirm which product, variants, functions and jurisdictions are within scope.
-
02
Qualify
Establish the regulatory perimeter
Determine whether the product is a device, IVD, accessory, software function, combination or borderline product.
-
03
Map
Extract the class-driving facts
Record purpose, users, duration, contact, invasiveness, energy, decisions, substances and other decisive characteristics.
-
04
Apply
Test all plausible rules and routes
Apply the EU rules or identify the FDA regulation, product code, controls, exemption status and likely premarket pathway.
-
05
Challenge
Check exceptions and edge cases
Evaluate special rules, implementing measures, accessories, mixed functions, variants and conflicting precedents.
-
06
Control
Document and connect the decision
Issue the rationale, define its assumptions and connect it to strategy, evidence, QMS and change control.
Three different systems
The same risk logic does not create the same classification method
EU MDR, EU IVDR and FDA each use a risk-based framework, but their rules, terminology, databases and route consequences are structurally different.
Medical devices
Classification follows Article 51 and Annex VIII of the MDR. The rules consider intended purpose, invasiveness, duration, anatomical site, active function, software impact and special characteristics.
- Class I is generally self-declared
- Notified-body involvement applies to relevant sterile, measuring and reusable-surgical aspects
- Classes IIa, IIb and III require notified-body involvement
In vitro diagnostics
Classification follows Article 47 and Annex VIII of the IVDR and reflects intended purpose, the significance of the information, individual risk and public-health risk.
- Class A is the lowest-risk class
- Class A sterile has limited notified-body involvement
- Classes B, C and D require notified-body involvement
FDA-regulated devices
Classification requires identification of the device type, classification regulation and product code, together with the applicable general and special controls and premarket pathway.
- Exemption must be checked with its limitations
- A predicate supports a 510(k) route but does not define every classification question
- De Novo may be available for certain novel low- to moderate-risk devices
Class-driving facts
The details that change the answer
A reliable review does not ask only what the product resembles. It asks what the product is intended to do, how it does it and what can happen when the resulting information or action is wrong.
Duration and contact
Transient, short-term or long-term use; body site; injured skin, mucosa, blood or central systems.
Invasiveness and implantation
Body-orifice, surgically invasive or implantable use and the anatomical structures involved.
Active function and software
Energy, monitoring, diagnosis, therapy and the consequences of software-provided information.
Substances and biological action
Absorption, biological effect, medicinal substances, tissues, cells and chemical change in the body.
Special product characteristics
Sterility, measuring function, reusable surgical use, nanomaterials and disinfection purpose.
IVD information and public-health impact
Purpose of the test, specimen, target condition, decision significance and risk of an incorrect result.
Common failure modes
Classification fails when the rationale is built backwards
A preferred commercial route is not evidence for a class. The route must follow from the controlled product facts and the applicable system.
Starting from a competitor’s class
Similar appearance does not establish the same intended purpose, technology or risk profile.
Writing the intended purpose after choosing the class
The product definition becomes commercially convenient but technically inconsistent.
Applying only the first plausible rule
Special rules, exceptions or a higher applicable class can be missed.
Assuming an accessory inherits the parent class
Accessories require their own classification analysis under the applicable jurisdiction.
Treating EU and US classes as equivalents
Shared class numbers do not mean shared rules, controls or market pathways.
Lifecycle control
Review the classification when the product or its context changes
Concept
Before development plans and commercial claims become fixed.
Design baseline
When technology, variants, accessories and software functions are defined.
Submission readiness
Before the dossier, application or conformity-assessment scope is finalised.
Change control
Whenever purpose, design, users, use environment, claims or markets change.
Connected work
Use the classification to drive the next regulatory decision
Classification has value only when it controls the strategy, evidence, dossier structure and external-review route that follow.
Regulatory strategy
Connect the class to markets, evidence, QMS work, timing and decision gates.
Build the strategy 02Medical devices and equipment
Translate technology, intended purpose and risk into a product-specific route.
Explore product support 03In vitro diagnostics
Apply the IVDR classification system and performance-evidence consequences.
Explore IVD support 04Medical software
Define software boundaries, medical purpose, decision impact and lifecycle controls.
Explore software supportPrimary sources
Classify against the current legal and regulatory source
Guidance, databases and classification regulations change. Confirm the current source and product facts before relying on an earlier decision.
Regulation (EU) 2017/745
Article 51 and Annex VIII for medical device classification
Regulation (EU) 2017/746
Article 47 and Annex VIII for IVD classification
Classify your medical device
FDA overview of class, product codes, databases and submission implications
Regulatory controls
FDA explanation of class I, II and III controls
Medical device classification product codes
FDA guidance on how product codes are used
Frequently asked questions
Medical device classification in practice
What information is needed to classify a medical device?
We normally need a controlled intended-purpose statement, indications, users, patient or specimen population, operating principle, technology, duration and site of contact, invasiveness, active functions, software role, medicinal or biological components, sterility, measuring function, variants, accessories and target markets.
Does one classification apply in every market?
No. Jurisdictions use different legal definitions, classification rules, databases and control systems. The same product can therefore have different class designations and regulatory routes in different markets.
Who determines the class of a medical device in the EU?
The manufacturer applies the MDR or IVDR classification rules and documents the rationale. Where a notified body is involved, it reviews the classification within the conformity-assessment process. Disagreements are handled through the procedures in the applicable Regulation.
Can every EU class I device be self-declared without a notified body?
No. Although class I devices are generally self-declared, notified-body involvement is required for the relevant sterile, measuring or reusable-surgical aspects. Other special procedures or product-specific requirements may also apply.
Does every FDA class II device require a 510(k)?
No. Many class II devices require a 510(k), but some are exempt subject to the applicable regulation and limitations of exemption. Novel low- to moderate-risk devices without a suitable predicate may be candidates for De Novo classification.
When should classification be reviewed again?
Reassess it when the intended purpose, indications, users, technology, software functions, duration or site of contact, variants, accessories or target markets change, or when authority feedback or new requirements affect the original rationale.
Start with the product facts
Know the class before committing to the route
Send us the intended purpose, product description, technology, variants and target markets. We will define the review scope and the classification questions that must be resolved.