Practical end‑to‑end support for IVDR readiness: classification, performance evidence planning, technical documentation structure and coordination toward conformity assessment.
Documentation readiness & gap assessment with prioritized actions.
Classification + route selection + evidence plan + timeline and responsibilities.
End‑to‑end support through documentation, evidence planning and conformity assessment readiness.
Exact scope depends on device type/class, existing documentation and evidence maturity.
Clarify intended purpose/claims and prepare a documented classification rationale.
See: IVD classification.
Plan the evidence package and structure documentation (PEP/PER) for IVDR expectations.
See: Performance evaluation.
Review your technical documentation and map claims to evidence to reduce rework during review.
Support with planning, submission package preparation and addressing questions (for many Class B/C/D IVDs).
EU AR services for medical devices are handled on getEAR.eu.
EU AR for medical devices (getEAR.eu) · Request EU AR service