What is MDR (EU 2017/745)?
The Medical Device Regulation (MDR) is the EU legal framework for placing medical devices on the EU market. It replaced the former Medical Devices Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD 90/385/EEC), strengthening requirements for safety, performance, clinical evidence and post‑market activities.
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.
When MDR applies
MDR applies to medical devices and accessories placed on the EU market. A correct assessment usually starts with:
- Product definition and intended purpose (including borderline considerations).
- Classification and a documented rationale — see device classification.
- Conformity assessment route and whether a Notified Body is required.
If you are a manufacturer outside the EU, you may need an EU Authorised Representative (EU AR). See getEAR.eu.
Key MDR building blocks
- Quality Management System (QMS) and regulatory processes (commonly aligned with ISO 13485).
- Technical documentation per Annex II and Annex III, including a clear GSPR checklist (Annex I).
- Clinical evaluation and clinical evidence (CER) — see clinical evaluation.
- Post‑Market Surveillance (PMS) / PMCF planning and reporting.
- Risk management across the lifecycle (commonly aligned with ISO 14971).
- UDI and traceability planning.
- EUDAMED obligations (availability depends on modules and your role).
- PRRC (Person Responsible for Regulatory Compliance) role and responsibilities.
Conformity assessment routes (overview)
The route depends on device classification, characteristics and the selected conformity assessment annexes.
- Class I: often self‑declaration; however Is / Im / Ir typically require Notified Body involvement.
- Class IIa / IIb / III: Notified Body involvement is required (scope and depth depend on the route).
We help determine the most appropriate route (e.g., Annex IX / X / XI) and prepare a submission package aligned with your device.
How to comply (practical roadmap)
- Define product and claims (intended purpose, target users/patients, setting, key performance).
- Classify the device and confirm the conformity assessment route.
- Build/adjust your QMS (design control, supplier control, PMS/vigilance, CAPA, etc.).
- Prepare technical documentation (Annex II/III) + GSPR checklist + evidence package.
- Generate/compile evidence (clinical evaluation, testing, usability, biocompatibility, software validation, etc.).
- Notified Body interaction (application, review rounds, QMS audit, technical documentation assessment).
- Maintain compliance after placing on market (PMS/PMCF, vigilance, updates, change control).
See our MDR support services
What we deliver
- Classification rationale (rules justification) and regulatory scope memo.
- MDR roadmap: route, documentation plan, timeline and responsibilities.
- Technical documentation drafting/review (Annex II/III structure).
- Clinical evaluation support (CER strategy, evidence plan).
- ISO 13485 QMS gap assessment and implementation support.
- Notified Body coordination (questions, findings, audit readiness).
What we need from you
- Device description, intended purpose, variants/SKUs.
- Current labeling/IFU and marketing claims.
- Design 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.
