Qualification and Rule 11 classification
Intended-purpose analysis, device and software boundaries, classification rationale and documentation of applicable MDR rules.
EU MDR CE Marking
EU MDR and CE marking support for medical device software.
We help medical device software manufacturers establish qualification and classification, select the conformity-assessment route, and build lifecycle technical documentation under Regulation (EU) 2017/745.
Selected clients
Healthcare teams we have supported
Scope and deliverables
EU MDR work included in the service.
The manufacturer remains legally responsible for conformity. We support the strategy, evidence and documentation; we do not act as a notified body or issue certificates.
Conformity-assessment roadmap
Applicable annex route, QMS and notified-body needs, EU Authorized Representative and importer interfaces, timing and dependency map.
GSPR and standards strategy
Annex I applicability, evidence references, harmonized standards and common specifications, with justified treatment of gaps or alternatives.
Annex II technical documentation
Device description, design and manufacturing information, risk management, product verification and validation, software and labeling evidence.
Clinical and usability evidence
Clinical evaluation planning and reports, PMCF strategy, usability engineering and alignment between claims and demonstrated performance.
Annex III and market readiness
PMS plan, reporting structures, vigilance and trend processes, registration inputs, Declaration of Conformity and controlled CE-marking checklist.
Ways to work together
Choose the support your team needs.
Full CE-marking workstream
Coordinate route, evidence and technical documentation through conformity-assessment readiness.
Classification and gap assessment
Independent review of device status, Rule 11 class, current file and prioritized remediation plan.
Notified-body response support
Interpret findings, establish root document gaps and prepare controlled evidence-based responses.
How it works
Our process.
- 1
Fix the route
Confirm intended purpose, qualification, classification and economic operators.
- 2
Map requirements
Connect GSPRs, standards, risks, claims and evidence ownership.
- 3
Build and review
Prepare Annex II and III documentation and challenge traceability and consistency.
- 4
Assess and maintain
Support notified-body review and transition the file into PMS and change control.
Regulations, standards and guidance considered
Regulation (EU) 2017/745MDR Annexes I–IIIMDR Rule 11MDCG 2019-11 rev.1ISO 13485:2016ISO 14971:2019IEC 62304IEC 62366-1
Frequently asked questions
Questions teams ask before they begin.
Does medical device software always require a notified body?+
No. Validly classified class I devices that are not sterile, measuring or reusable surgical instruments may generally self-declare. Class IIa, IIb and III devices require notified-body involvement, subject to the selected conformity route.
How does Rule 11 classify software?+
It considers the purpose of information used for diagnostic or therapeutic decisions and the consequence of those decisions, plus software that monitors physiological processes. Software outside those provisions may fall into class I. Product-specific wording and clinical context matter.
What belongs in MDR technical documentation?+
Annex II covers device description, information supplied, design and manufacturing, GSPR evidence, risk management and verification and validation. Annex III covers PMS documentation. The file should remain current and cross-referenced, not be a static submission binder.
Does ISO 13485 certification equal CE marking?+
No. ISO 13485 supports quality-system conformity, but CE marking also requires device-specific conformity assessment, technical and clinical evidence, PMS arrangements, economic-operator duties and a Declaration of Conformity.
Can Predetics select or act as our notified body?+
We can help define the needed designation scope and support readiness and interactions. The manufacturer contracts with an appropriately designated notified body; Predetics is not a notified body and cannot issue an MDR certificate.
Can CE marking be guaranteed?+
No. The manufacturer and, where required, notified body complete the legal conformity process. Review findings, evidence gaps and regulatory changes can affect timing and outcome.
Start with the product you have