Regulation (EU) 2017/746 · Article 48 · Visual route map
The IVDR CE-marking route
Classification chooses the gate. Evidence keeps it open.
CE marking is not one final certificate. It is the visible output of a connected system linking intended purpose, risk class, performance evidence, quality controls, regulatory roles and lifecycle surveillance.
Open the route map ↓Intended purpose locked
Market release + lifecycle loop
The first decision
The class changes the assessment route
No notified body for the standard route
Only the sterile-condition aspects
QMS and technical-documentation assessment
Laboratory, expert and batch mechanisms where applicable
The complete route
From product definition to a living CE system
Read from top to bottom. The centre rail shows the regulatory sequence. Parallel lanes show work that must mature together rather than wait for the previous box to finish.
Product identity gate
Lock the intended purpose before the route begins
Define the analyte or marker, specimen, target population, intended user, use environment, test function, claimed performance and clinical context. Qualification as an IVD and every later decision depend on this controlled statement.
Annex VIII gateway
Apply every relevant rule and record the highest class
IVDs fall into classes A, B, C or D according to intended purpose and inherent risk. Review all implementing rules, all seven classification rules and every applicable indent. Accessories are classified in their own right.
Three parallel workstreams
Build the organisation, evidence and dossier as one system
These lanes exchange inputs continuously. Treating them as independent document projects creates contradictions that surface during technical review or audit.
Quality and organisation
Article 10 quality management, design control, supplier control, production, corrective action and post-market processes.
- QMS proportionate to risk and device type
- PRRC coverage under Article 15
- EU authorised representative for a non-EU manufacturer
Performance evidence
Scientific validity, analytical performance and clinical performance joined in a performance evaluation.
- Performance evaluation plan and report
- Performance studies where required
- Post-market performance follow-up plan
Technical documentation
Annexes II and III connect product design, risk management, GSPR evidence, verification, labelling and surveillance.
- Device description and specifications
- Risk and GSPR traceability
- Manufacturing, verification and lifecycle records
Article 48 route gate
Send the product through its class-dependent assessment
The standard routes below apply to devices other than devices for performance studies. Special characteristics can add review steps without changing the underlying risk class.
Self-declaration unless supplied sterile
For a non-sterile class A IVD, the manufacturer draws up Annexes II and III technical documentation and issues the EU declaration of conformity without notified-body involvement.
Notified-body QMS route
Annex IX Chapters I and III apply, including assessment of technical documentation for at least one representative device per category.
Notified-body route with deeper technical review
Use Annex IX Chapters I and III with assessment of at least one representative device per generic device group, or Annex X coupled with Annex XI except Section 5.
Full notified-body route with added scrutiny
Use Annex IX Chapters I, II except Section 5, and III, or Annex X coupled with Annex XI. The notified body assesses the technical documentation for the device.
External assessment gate
Choose a designated notified body and close the findings
Where notified-body involvement is required, confirm that the body is designated under the IVDR for the relevant IVD codes. Align the application scope, device groups, sites and subcontractors before submission.
Class A non-sterile products bypass this external gate, but they do not bypass technical documentation, performance evaluation, risk management, registration or post-market obligations.
Market-release interlock
Complete the legal release sequence before applying CE
The certificate is an input, not the final action. The manufacturer remains responsible for the declaration, registrations, product information and release decision.
- 01Confirm economic-operator architecture
Manufacturer, authorised representative where required, importer and PRRC are defined and contractually aligned.
- 02Assign Basic UDI-DI and UDI
Connect identifiers to the device family, labels, records and registration dataset.
- 03Complete required EUDAMED registrations
Register actors and devices and maintain the information under the mandatory modules.
- 04Issue the EU declaration of conformity
The manufacturer formally declares conformity with the IVDR and other applicable Union legislation.
- 05Apply the CE marking
Add the notified-body identification number where the applicable conformity assessment involved a notified body.
Closed lifecycle loop
Keep the evidence, QMS and product aligned after launch
CE marking remains credible only while new information returns to risk management, performance evaluation, technical documentation and corrective-action systems.
PMS, complaints, scientific literature, user feedback and performance data
PMPF, trend detection, benefit-risk review and signal assessment
Vigilance, CAPA, field action, design or information changes
PMS report for A and B, annual PSUR for C and D, dossier and QMS
Route modifiers
Five switches can add another control layer
Check these characteristics early. Discovering one after the assessment strategy is fixed can reopen the route.
Technical-documentation assessment addresses lay use, result interpretation and risk controls.
Additional technical-documentation procedures apply for classes B, C and D.
The notified body consults the relevant competent authority or EMA on suitability with the medicinal product.
EU reference laboratory and expert-panel mechanisms apply under the conditions set by Article 48.
A written mandate and EU regulatory interface must be in place before market access.
System status · 28 May 2026
The first four EUDAMED modules are mandatory
Actor registration, UDI and device registration, notified bodies and certificates, and market surveillance moved into mandatory use. Build registration data as controlled regulatory data, not as a final clerical upload.
Release checkpoint
The CE mark is the output, not the project
A release decision is defensible only when the product identity, class, evidence, QMS, assessment route, registrations and post-market system tell the same story.
Official sources
From map to market plan
