An IVD that is already registered in China, Japan, South Korea, Singapore or another Asian market does not start from zero when entering Europe. Existing technical documentation, analytical studies, clinical performance data, risk management files and quality records may all be valuable.
But an existing approval is not a regulatory passport.
Under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), the manufacturer must establish that the device, its intended purpose, claims, classification, technical documentation and performance evidence meet European requirements. The practical question is therefore not whether an Asian dossier can simply be submitted in Europe. It is which parts remain applicable, which require justification or adaptation, and which gaps must be closed before the European conformity assessment begins.
For Asian IVD manufacturers planning CE marking, answering that question early can prevent an established dossier from becoming an expensive source of regulatory rework.
A cross-border IVD case shows why dossier consistency matters
A case shared with MDx CRO by ElendiLabs, a Hong Kong-based CRO, illustrates the problem particularly well.
The manufacturer had an NMPA-approved Class C infectious-disease rapid immunoassay intended to support both professional use and self-testing. The existing NMPA approval was being used as the reference approval for a subsequent Hong Kong MDACS application.
The application did not achieve listing.
The central problem was not simply a missing certificate. Material inconsistencies existed across the regulatory package, including manufacturing addresses and QMS scope, product and model naming, the intended-use wording approved through the NMPA process, and the instructions provided for professional and lay users. The self-testing instructions also retained elements that depended on professional interpretation.
This was a Hong Kong MDACS case, not an EU IVDR assessment, so the regulatory pathways should not be equated.
The transferable lesson is broader: the existence of an approval does not compensate for a dossier that describes different versions of the product, its manufacturer, its users or its claims.
For a manufacturer moving from Asia into Europe, that is a useful place to start.
1. Define the European intended purpose before deciding what can be reused
One of the most common mistakes in cross-border regulatory planning is beginning with the existing dossier instead of beginning with the product that will actually be placed on the European market.
Before assessing evidence transferability, define the proposed EU intended purpose clearly:
- What analyte or marker is being detected or measured?
- What is the target population?
- What specimen types will be used?
- Who is the intended user?
- Where will the test be performed?
- Which indications and clinical claims will be made?
- Are there professional-use, near-patient or self-testing claims?
- Will the European version have the same models, accessories, software and workflow as the version already approved elsewhere?
Only then should the existing Asian dossier be mapped against the proposed European product.
A study may have been appropriate for the original intended purpose but insufficient for a broader EU claim. Conversely, existing evidence may remain highly valuable when the product configuration, population, specimen type, use environment and performance claims remain relevant.
This is why an EU market-entry assessment should start with claim and product definition, not document conversion.
2. Reassess classification under IVDR
An IVD manufacturer should not assume that a classification assigned in another regulatory system will translate directly into the same European class.
Classification under IVDR must be determined using the European classification rules and the device’s European intended purpose.
This matters because classification affects the conformity assessment route, Notified Body involvement and the regulatory planning needed before market entry. The European Commission published the latest revision of its IVD classification guidance, MDCG 2020-16 rev.5, in September 2026.
Self-testing is a good example of why this assessment should happen early. Under IVDR Rule 4, devices intended for self-testing are generally Class C, with specified exceptions.
A manufacturer therefore needs to establish the EU classification independently rather than treating an NMPA, PMDA, MFDS or other national classification as the starting conclusion.
For a complete overview of classification, conformity assessment and the CE-marking pathway, see our regulatory process for IVDs in Europe.
3. Build an evidence transferability matrix: reuse, justify, bridge or generate
Existing evidence should not automatically be discarded simply because it was generated for another market.
Nor should it automatically be accepted.
A more useful approach is to classify the existing evidence into four categories:
| Existing evidence | EU market-entry decision |
|---|---|
| Directly relevant to the proposed EU device and claims | Reuse and integrate into the IVDR evidence architecture |
| Relevant but with identifiable limitations or differences | Reuse with an explicit applicability or bridging justification |
| Potentially useful but insufficient for a specific EU claim or requirement | Identify the gap and supplement it |
| Not representative of the European device, intended purpose or evidence need | Generate new evidence |
Under Annex XIII of the IVDR, performance evaluation is a continuous process covering scientific validity, analytical performance and clinical performance for the device’s intended purpose. The performance evaluation plan must define how the necessary clinical evidence will be generated and assessed.
A robust IVDR Performance Evaluation Plan should be built as a single, integrated lifecycle framework that connects Scientific Validity, Analytical Performance and Clinical Performance.
Catarina Sepúlveda, IVD Director, MDx CRO
This is consistent with the evidence architecture used by MDx CRO’s IVD specialists: begin with the intended purpose and claims, then map each claim to the evidence required to support it.
For an Asian manufacturer, the key question is therefore not:
“Can we use our Chinese clinical performance study in Europe?”
It is:
“Which European claim does this study support, for which device configuration, population and specimen type, and what uncertainty remains after we use it?”
That distinction determines whether an existing study saves substantial work or creates a false sense of submission readiness.
4. Run a consistency audit across manufacturer, QMS, sites and product identity
The ElendiLabs case also illustrates a problem that can look administrative until it blocks an assessment: the same device must remain identifiable throughout the regulatory package.
Before an EU submission progresses, manufacturers should reconcile at least:
- legal manufacturer name;
- registered addresses;
- manufacturing sites;
- QMS scope;
- model and catalogue numbers;
- device variants;
- product names;
- certificates;
- technical documentation references;
- labels and packaging;
- instructions for use;
- intended purpose and claims.
The objective is not merely to make names look similar.
The objective is to demonstrate traceability between who manufactures the device, where it is manufactured, which device is being assessed, what configuration is being marketed and which evidence applies to that configuration.
Build your dossier so a Notified Body reviewer can follow the logic for each claim and see how the supporting evidence fits together.
Carlos Galamba, CEO & Head of IVD, MDx CRO
This is particularly important when documentation has accumulated over several years, multiple distributors or regulatory submissions, or when different versions of product names and addresses have been translated between languages.
An EU regulatory gap assessment should identify these inconsistencies before the technical documentation reaches the Notified Body.
We provide regulatory affairs and technical documentation support, including gap assessment, dossier remediation and planning for IVDR submissions.
5. Treat self-testing as a product and evidence decision, not an IFU edit
For an IVD originally designed for professional users, adding a self-testing or lay-user claim can change much more than the wording on the label. The user, use environment and workflow have changed.
A lay user may need to collect the specimen, prepare the test, perform each step correctly, recognise invalid results and interpret the final result without the assumptions that can reasonably be made for a trained healthcare or laboratory professional.
The Hong Kong case is a useful warning. The home-use instructions still depended on professional interpretation, undermining the logic of the self-testing claim.
For European planning, the intended user and use environment should therefore be incorporated into product development, risk management, labelling and usability activities from the beginning.
Our’s usability engineering services cover home-use, self-testing and point-of-care IVDs, including lay-user evaluation, use specification, formative work, summative validation and IFU assessment.
The commercial implication for manufacturers is straightforward: decide whether self-testing belongs in the European intended purpose before the evidence programme and submission strategy are fixed.
6. Map the European regulatory actors early
Market entry is not only a technical-documentation exercise.
A manufacturer established outside the European Union must also define the relevant European economic-operator structure. Under Article 11 of the IVDR, a manufacturer that is not established in an EU Member State must designate a sole authorised representative before the device can be placed on the Union market.
Depending on the programme, the manufacturer may also need to coordinate with a Notified Body, importer, distributors and, where performance studies are planned, the relevant study stakeholders and authorities.
These roles should be mapped early because they affect responsibilities, documentation and the practical sequence of the European programme.
An Asian local representative or regulatory agent should not be assumed to fulfil the European Authorised Representative role automatically.
We provide EU Authorised Representative and representative services alongside regulatory and clinical support, allowing the economic-operator strategy to be considered together with the broader EU market-entry plan.
7. Involve the European regulatory and CRO team before the evidence plan is frozen
For manufacturers with an established product and existing evidence, the highest-value regulatory work often takes place before a new European study is commissioned.
At that stage, the team can still ask:
- Can this existing analytical study support the proposed European claims?
- Are the clinical performance data applicable to the intended EU population and workflow?
- Is an additional study necessary, or would a focused gap-closing strategy be sufficient?
- Should professional-use and self-testing ambitions be handled differently?
- Is the proposed European classification correct?
- Does the existing technical documentation describe the same commercial configuration?
- Are the proposed claims broader than the available evidence?
- Which decisions could invalidate existing evidence if they change later?
Once a protocol has been finalised, sites contracted, specimens collected or a pivotal study completed, correcting a strategic mismatch becomes much more difficult.
My advice is not to wait for formal enforcement language. If the direction is clear, start aligning your evidence strategy now.
Carlos Galamba, CEO & Head of IVD, MDx CRO
The objective of involving a European IVD CRO early is therefore not to reproduce an Asian dossier in a European format. It is to develop a single coherent product and evidence strategy with the necessary jurisdiction-specific regulatory adaptations.
For manufacturers that need clinical or performance evidence in Europe, we combine IVD regulatory strategy, analytical and clinical performance studies, medical writing and technical documentation support within one IVD-focused CRO team.
EU readiness checklist for Asian IVD manufacturers
Before committing to an IVDR submission or new European evidence-generation programme, review the following:
| Area | Question to answer |
|---|---|
| Intended purpose | Is the proposed EU intended purpose final and clearly defined? |
| Claims | Does each EU claim have identifiable supporting evidence? |
| Classification | Has the device been independently classified under IVDR? |
| Product configuration | Are the EU models, variants, software and accessories clearly defined? |
| Existing evidence | Has each study been assessed for relevance to the EU device and intended purpose? |
| Performance evaluation | Are scientific validity, analytical performance and clinical performance connected to the claims? |
| Manufacturer and sites | Do legal manufacturer, manufacturing sites and QMS documentation align? |
| Labelling and IFU | Do the labels and instructions accurately reflect the European device and intended users? |
| Usability | Have professional, near-patient and lay-user requirements been assessed separately where relevant? |
| Economic operators | Is the EU Authorised Representative and broader operator strategy defined? |
| Evidence gaps | Is there a documented plan for evidence that must be bridged or generated? |
| Submission strategy | Are regulatory, clinical and operational dependencies mapped before major commitments are made? |
What should an Asian IVD manufacturer do first?
If your company already holds an NMPA, PMDA, MFDS, HSA or another market approval, do not begin European planning by rewriting the dossier.
Begin by comparing the approved product and existing evidence package with the exact IVD you intend to place on the European market.
That gap assessment should identify what can be retained, what requires an EU-specific justification, what must be adapted and which unresolved questions could require additional analytical or clinical performance evidence.
From there, the manufacturer can build a realistic IVDR pathway rather than discovering fundamental inconsistencies during conformity assessment.
We support IVD manufacturers with EU regulatory strategy, IVDR technical documentation, performance evaluation, analytical and clinical performance studies, usability engineering and representative services.
Planning European market entry with an existing Asian IVD dossier?
Talk to our experts about an EU regulatory and evidence-readiness assessment before your submission or study strategy is fixed.
Frequently asked questions
An NMPA approval does not replace the conformity assessment required under EU IVDR. However, the documentation and evidence developed for an NMPA submission may still be useful if it is relevant to the device, intended purpose, claims, users, specimens and configuration proposed for Europe.
The appropriate approach is to assess the existing dossier against IVDR requirements and determine what can be reused, what requires justification or adaptation, and what additional evidence is needed.
Potentially, yes. The geographical origin of a study does not by itself determine whether the data are useful.
The manufacturer needs to assess whether the study design, population, device configuration, specimen type, methods, endpoints and results are relevant to the European intended purpose and claims. Any limitations in applicability need to be addressed transparently. Additional evidence may be necessary where clinically relevant uncertainties remain.
Not necessarily. Classification must be established independently under the IVDR classification rules using the European intended purpose of the device. The latest European Commission guidance on IVDR classification is MDCG 2020-16 rev.5, published in September 2026.
Yes. Under Article 11 of the IVDR, where the manufacturer is not established in an EU Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
They can materially affect classification, usability planning, risk management, labelling and the evidence needed to support the intended use. For this reason, self-testing should be defined as part of the intended-purpose and product strategy rather than introduced as a late labelling change.
Ideally, before the European claims, evidence plan and any new performance studies are fixed. Early assessment allows existing evidence to be evaluated before additional testing or clinical work is commissioned and can identify regulatory and operational dependencies while they are still relatively easy to address.
A useful starting package normally includes the intended purpose, current product configuration and variants, existing regulatory approvals, technical documentation, QMS and manufacturing information, risk management documentation, analytical and clinical performance evidence, labelling and IFU, usability evidence where applicable, and the intended European launch strategy.
