Qualification
Does the product have an individual or public-health medical purpose under the MDR, and what is the device boundary?
European Union regulatory market
EU MDR and CE marking for medical device software.
We help medical device software teams define their MDR route, build Annex II and III documentation, plan clinical evidence and prepare for conformity assessment.
Discuss your market plan →Pathways and services
Regulatory support for European Union.
Market access
EU MDR CE marking
Qualification, Rule 11 classification, conformity-assessment planning and technical documentation.
View service →EvidenceClinical evidence
Clinical evaluation strategy, literature methods, evidence-gap analysis and PMCF planning.
View service →Use safetyHuman factors and usability
Use specification, use-related risk analysis and IEC 62366-1 lifecycle evidence.
View service →LifecyclePost-market surveillance
PMS plans and reports, PMCF interfaces, vigilance support and PSUR structures where applicable.
View service →What we need to determine
The decisions that shape your application.
Classification
How do Rule 11 and other applicable rules map to the information supplied by the software and the clinical consequence of decisions?
Conformity assessment
Can the manufacturer self-declare, or is a notified body needed for the class and route?
Evidence strategy
How will clinical, performance, usability and software evidence demonstrate each applicable safety and performance requirement?
How we work
From classification to market entry.
- 1
Qualify and classify
Document medical purpose, software boundary, class, rationale and economic-operator model.
- 2
Plan conformity
Map GSPRs, standards, evidence, QMS work and notified-body dependencies.
- 3
Build the file
Develop controlled Annex II and III technical documentation with the required cross-references.
- 4
Assess and maintain
Support conformity assessment and establish registrations, PMS, vigilance and change control.
Core regulations, standards and guidance
Regulation (EU) 2017/745MDR Annexes I–IIIMDR Rule 11MDCG 2019-11 rev.1MDCG 2020-1ISO 13485:2016ISO 14971IEC 62304IEC 62366-1
FAQ
Common questions about European Union.
MDR classification, notified-body scope, transitional provisions and EUDAMED duties can change with product facts and implementation dates. Confirm the current legal and authority position for each market action.
Is all health software a medical device under the MDR?+
No. Qualification depends on intended purpose and whether the software performs an action on data for the benefit of individual patients beyond storage, communication or simple search. Wellness and administrative products may fall outside the MDR, but the reasoning should be documented.
Does Rule 11 automatically make software class IIa?+
No. Rule 11 can lead to class IIa, IIb or III depending on the significance and consequences of the information supplied for diagnostic or therapeutic decisions; other software may be class I. The exact intended purpose and foreseeable clinical scenario control the analysis.
Does a harmonized standard guarantee conformity?+
No. Correct use of a harmonized standard can provide a presumption of conformity for covered requirements, but the manufacturer remains responsible for all applicable GSPRs and for justifying alternatives or gaps.
Is EUDAMED fully mandatory now?+
No. Four modules became mandatory on 28 May 2026, while the vigilance/PMS and clinical-investigation modules follow separate functionality notices and transition dates. Current Commission notices and national arrangements should be checked at the time of action.
Can you issue a CE certificate?+
No. Predetics can support strategy and documentation. Where notified-body involvement is required, only a designated notified body can perform that conformity assessment and issue the relevant certificate; the manufacturer affixes the CE mark after completing applicable requirements.