MDCG 2025-9: Breakthrough devices (BtX), explained

Who this applies to

This guidance applies to medical devices and IVDs across technologies and risk classes where the manufacturer wants breakthrough technology (BtX) designation. It is written for manufacturers, EMA expert panels and notified bodies, with roles for competent authorities as well.

Custom-made devices, devices manufactured and used in-house under the health-institution route, and MDR Annex XVI products without an intended medical purpose are outside its scope. A device may qualify both as breakthrough and as an orphan medical device; MDCG 2025-9 and MDCG 2024-10 can then apply together.

The two breakthrough criteria

A device must meet both criteria:

1. High degree of novelty. The novelty can lie in the technology, material, design, manufacturing process, mechanism of action, biomarker or analyte, sample type, automation, AI, clinical procedure or application in practice. An incremental feature or routine iteration is unlikely to be enough.
2. Significant positive clinical impact. The device must be reasonably expected to produce a clinically meaningful improvement for a life-threatening or irreversibly debilitating disease or condition — either compared with available alternatives and the state of the art, or by addressing an unmet need where alternatives are absent or insufficient.

The comparison is clinical, not promotional. Faster workflow, lower cost, portability or scalability can support the case where they translate into better patient or public-health outcomes. Novel engineering without a meaningful health impact does not meet the test; a clinically useful device without a high degree of novelty does not meet it either.

A complete clinical data set is not required at designation. The manufacturer does need enough literature, scientific-validity evidence, pre-clinical data, preliminary clinical or performance data, and state-of-the-art analysis to make the expected impact credible.

Designation is not certification

The manufacturer requests an opinion on BtX status from an expert panel established under MDR Article 106. A request can be made at any stage of development once there is enough evidence to address both criteria. The panels aim to issue the opinion within 60 days and prioritise BtX applications.

A positive opinion gives the device breakthrough status and access to the supports described in the guidance. It does not:

• place the device on the market or replace CE marking;
• certify conformity with the MDR or IVDR;
• guarantee that a notified body will issue a certificate;
• grant market exclusivity; or
• prevent another device with the same intended purpose from receiving designation.

Once granted, status may remain valid as long as needed for the framework, even if a similar device reaches the market later. The practical request channel and availability of pilot expert-panel services should be checked with the Commission/EMA before planning submission dates.

What the pathway can change

The benefit is earlier and more coordinated regulatory interaction. Depending on the device and its stage, this can include:

• an expert-panel opinion on breakthrough status;
• early advice on clinical-development or performance-study strategy;
• MDR Article 61(2) advice for class III and certain class IIb active devices;
• advice for other device classes or IVDs under the pilot framework;
• coordination with the notified body and, where applicable, the Clinical Evaluation Consultation Procedure; and
• prioritised, structured conformity-assessment work by notified bodies.

The designation is therefore most valuable before the evidence plan hardens. Bring specific methodological questions — endpoints, comparators, study population, performance claims, residual uncertainty and PMCF/PMPF — rather than asking the panel to approve a finished strategy in the abstract.

Evidence can be staged, not skipped

MDCG 2025-9 allows a proportionate balance between pre-market and post-market evidence so patient access is not delayed unnecessarily. It does not lower the requirement for sufficient evidence of safety, performance and clinical benefit.

The technical and clinical programme still needs rigorous non-clinical verification and validation, usability, manufacturing validation, clinical evaluation or IVD performance evaluation, and a current state-of-the-art comparison. Where uncertainty remains at certification, the notified body may use specific certificate conditions or provisions: defined PMCF/PMPF studies, enhanced monitoring, milestone reporting, user information and more frequent review.

The CER or PER should explain why the device meets the breakthrough criteria, what advice was received and how it was considered, what pre-market evidence supports access, which uncertainty moves post-market, and when the report will be updated. Failure to complete binding post-market conditions can ultimately affect certificate validity.

What this means for you, practically

1. Write a two-part eligibility memo. Keep the novelty argument separate from the clinical-impact argument, and compare both against the current state of the art and alternatives.
2. Apply when advice can still change the plan. Assemble enough evidence to make the criteria credible, but approach the panel before pivotal study decisions become expensive to reverse.
3. Ask answerable questions. Define the endpoint, comparator, population, sample size, pre-market evidence threshold and post-market uncertainty on which you need input.
4. Pre-negotiate the evidence bridge. Show how PMCF/PMPF, registries, real-world data, milestones and stopping or escalation rules will confirm any claims not fully resolved pre-market.
5. Keep designation out of the marketing approval column. Track BtX opinion, notified-body conformity assessment, CE certificate, national study permissions and reimbursement as separate decisions with separate owners.