MDR certification support
We provide end‑to‑end MDR (EU 2017/745) support for medical device manufacturers — from strategy and classification through technical documentation, clinical evidence, ISO 13485 QMS and Notified Body coordination.
Manufacturer outside the EU?
If your company is located outside the EU, you may need EU Authorised Representative services to place products on the EU market and to respond to market surveillance requests.
EU-based manufacturer? Continue below — we can still support documentation and conformity assessment readiness.
Typical engagement options
Quick check
Documentation readiness & gap assessment with prioritized actions.
Roadmap
Classification + route selection + evidence plan + timeline and responsibilities.
Full project coordination
End‑to‑end support through documentation, evidence planning and conformity assessment readiness.
Exact scope depends on device type/class, existing documentation and evidence maturity.
What MDR certification typically includes
Every project is different, but successful MDR certification almost always requires alignment across regulatory strategy, documentation, evidence and quality management.
Regulatory strategy
- Device classification and borderline assessment
- Conformity assessment route (e.g., Annex IX / X / XI)
- Timeline, milestones and readiness plan
- Gap analysis against MDR requirements
Technical documentation (Annex II/III)
- Device description, design & manufacturing information
- GSPR checklist (Annex I) and evidence mapping
- Risk management file (commonly ISO 14971)
- Labeling/IFU review (claims aligned to evidence)
Clinical evidence
- Clinical evaluation plan and CER strategy
- Literature search and appraisal
- Clinical investigation support (when needed)
- PMS/PMCF integration into the lifecycle
See also: Clinical evaluation.
Quality management (QMS)
- ISO 13485 implementation / gap assessment
- Process documentation and records readiness
- Internal audits and management review support
- Change control and post‑market processes
Notified Body coordination
- NB selection support (scope/capacity fit)
- Application preparation and submission package
- Audit preparation and attendance
- Resolution of non‑conformities and findings
Special topics (as applicable)
- Biocompatibility evaluation (commonly ISO 10993)
- Usability engineering (IEC 62366)
- Software documentation (IEC 62304) and cybersecurity alignment
- UDI and traceability planning
What we need from you
- Device description, intended purpose, variants/SKUs
- Current labeling/IFU and marketing claims
- Design, verification/validation and risk documentation (if available)
- Clinical data / literature / PMCF evidence (if available)
- Current QMS status and key procedures (if any)
Typical timelines
- Class I (self‑declaration): often weeks (depending on documentation readiness).
- Class IIa/IIb/III: typically months; Notified Body timelines depend on capacity and scope.
