IVDR · FDA · performance evidence · lifecycle compliance
Build the IVD pathway around the clinical decision it supports
Intended purpose determines what the product is, how it is classified and which evidence must support it. MDRC turns that definition into a controlled regulatory plan for the European Union or United States.
Regulatory starting point
Start with the information the test is intended to provide
An IVD is not defined merely by being used in a laboratory. The product’s claims, specimen, analyte or measurand, target population, user, setting and role in a medical decision establish its regulatory identity.
Define the claim
State what is detected or measured, for whom, from which specimen, by whom and for which screening, diagnosis, prediction, monitoring or treatment-selection purpose.
Map the system
Identify reagents, calibrators, controls, instruments, specimen receptacles, software, accessories and configurations that together deliver the claimed result.
Set the boundary
Distinguish an IVD from a general laboratory product, research-use-only product, medical device, medicinal product or non-medical software.
The IVDR definition covers reagents, kits, calibrators, control materials, instruments, equipment, software and systems intended for in vitro examination of human-derived specimens. Specimen receptacles are also IVDs.
EU classification
Apply the IVDR rules to the intended purpose, not the product name
Annex VIII places IVDs in classes A, B, C or D according to the consequences of an incorrect result for the individual and public. The rule rationale must be documented for the actual marketed claims.
Lower risk
Examples may include general laboratory instruments and certain reagents or specimen receptacles, where the specific rule conditions are met.
Moderate individual or low public risk
The residual class for IVDs not covered by another rule and specific devices captured by the class B provisions.
High individual or moderate public risk
May include many infectious-disease tests, companion diagnostics, genetic tests, self-tests and near-patient tests, depending on intended purpose.
High public and individual risk
Includes specified high-risk applications such as certain transmissible-agent testing for blood, cells, tissues and organs.
These are orientation points, not a substitute for applying every relevant Annex VIII rule. Accessories are classified separately in their own right, and IVD software follows the same classification rules.
Regulatory execution
Turn the route into a controlled work programme
MDRC can take responsibility for a defined workstream or coordinate the complete programme from initial product definition to market entry.
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01
Qualification and intended purpose
Product boundary, claims, specimen, analyte, users, setting, population and configurations.
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02
Classification and pathway
IVDR rule rationale or FDA device identification, controls and premarket route.
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03
Gap and evidence strategy
Existing data, missing studies, standards, dependencies, sequence, budget and decision points.
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04
QMS and technical documentation
Design control, risk management, manufacturing information, GSPR evidence and controlled records.
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05
Performance and validation
Scientific validity, analytical and clinical performance, usability, stability, software and cybersecurity.
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06
Review, registration and lifecycle
Notified-body or FDA interaction, market-entry obligations, PMS, vigilance and controlled change.
Check the structure of your IVDR technical documentation
Use the interactive checklist to identify available evidence and open documentation items.
Performance evidence
Make every claim traceable to the right evidence
The performance evaluation is a living assessment. It must connect the intended purpose to scientific validity, analytical performance and clinical performance, then remain aligned with risk management and post-market information.
Scientific validity
Association of the analyte or marker with the clinical condition or physiological state.
Analytical performance
Ability of the device to correctly detect or measure the analyte under the defined conditions of use.
Clinical performance
Ability of the result to correlate with the relevant clinical condition, process or state for the intended population.
Claims · benefits · risks · limitations · evidence gaps · lifecycle updates
Analytical validation
Accuracy, precision, analytical sensitivity and specificity, measuring range, interference, cross-reactivity and specimen handling as applicable.
Clinical evidence
Study design, representative specimens and populations, comparator, acceptance criteria, statistical analysis and clinically meaningful interpretation.
System verification
Instrument, reagent, calibrator, control, software, usability, interoperability, transport and stability evidence for the marketed system.
Lifecycle control
Post-market performance follow-up, PMS, vigilance, trend reporting, change assessment and periodic evidence updates.
How we can help
Use focused expertise or an integrated regulatory team
Strategy and readiness
- Qualification and classification opinions
- EU and US pathway assessment
- Gap analysis and remediation plan
- Notified-body and FDA interaction strategy
Documentation and QMS
- IVDR technical documentation
- Quality-system procedures and records
- Risk management and GSPR evidence
- Labels, IFU and market-entry documentation
Performance evidence
- Performance evaluation planning and reports
- Analytical and clinical study strategy
- Literature review and scientific validity
- PMPF, PMS and evidence maintenance
EU presence and oversight
- EU authorised representative services
- External PRRC services
- EUDAMED and economic-operator coordination
- Lifecycle compliance and change review
EU and US planning
Reuse the evidence where justified, but determine each legal route separately
A common product and evidence architecture can improve efficiency. It does not make EU classification, FDA authorization or laboratory obligations interchangeable.
IVDR conformity route
Apply the IVDR definition and Annex VIII rules. Class A non-sterile devices may generally be self-declared; class A sterile and classes B, C and D require notified-body involvement at the applicable depth.
Core workstreamsClassification · QMS · technical documentation · performance evaluation · CE marking · EUDAMED · PMS and PMPF
FDA device-specific route
Identify the device type, classification regulation, product code, controls and predicate landscape. Depending on the device, the route may be exempt, 510(k), De Novo or PMA. CLIA categorization is a separate determination.
Core workstreamsRegulatory assessment · pre-submission strategy · analytical and clinical evidence · submission · establishment and post-market obligations
Primary sources
Confirm the route against current legislation and authority guidance
Regulation (EU) 2017/746
Official IVDR text on EUR-Lex
MDCG-endorsed guidance
European Commission guidance arranged by subject
FDA in vitro diagnostics
Official FDA resources, databases and regulatory links
IVDR technical documentation structure
MDRC one-page PDF overview of Annexes II and III
Frequently asked questions
Practical IVD distinctions
The final answer depends on the exact intended purpose, marketed configuration and jurisdiction. These distinctions prevent common early-stage pathway errors.
What makes a product an IVD in the European Union?
The intended purpose, examination of specimens derived from the human body and information provided are decisive. The definition covers reagents, kits, calibrators, controls, instruments, software and systems, as well as specimen receptacles.
Does every IVD require a notified body?
No. Class A non-sterile devices generally follow self-declaration. Class A sterile devices require notified-body involvement for the sterility aspects, while classes B, C and D require notified-body assessment.
What does an IVDR performance evaluation include?
It establishes scientific validity, analytical performance and clinical performance for the intended purpose. The three elements are assessed together and maintained throughout the device lifecycle.
Can the EU IVD class be reused for the United States?
No. IVDR classification and FDA classification are separate legal determinations. The US route depends on the device type, classification regulation, product code, controls and predicate landscape.
Is CLIA categorization the same as FDA authorization?
No. FDA authorization determines whether the device may be marketed, while CLIA categorization concerns the complexity of laboratory testing. The two processes address different regulatory questions.
Your next decision
Define the shortest defensible route from test concept to market
Tell us the claimed purpose, specimen, technology, development stage and target market. We will identify the critical pathway decisions and propose a practical scope of work.
Map your IVD project