EU Medical Device Regulation
EU regulation governing the production and distribution of medical devices in the European market.
Quick Facts
- Documents Included
- 18
- Category
- Healthcare & Life Sciences
- Regions
- European Union / UK
- Compliance Domains
- 5 domains
What's Included
SeedGovernance provides 18 ready-to-use templates for EU MDR, covering 5 compliance domains. Each document is pre-filled with framework-specific guidance so you can start immediately.
Device Classification
Policies, processes, and evidence templates
Clinical Evaluation
Policies, processes, and evidence templates
Post-Market Surveillance
Policies, processes, and evidence templates
UDI
Policies, processes, and evidence templates
Technical Documentation
Policies, processes, and evidence templates
How SeedGovernance Helps with EU MDR
Beyond templates, our platform guides you through every step of EU MDR compliance.
Assessment Wizard
Answer guided questions to assess your EU MDR readiness and identify gaps.
Gap Analysis
Automatically surface what's missing from your EU MDR compliance programme.
Document Library
18 pre-built templates tailored to EU MDR requirements.
Operations Modules
Track incidents, changes, risks, and vendors — all mapped to EU MDR controls.
KPI Dashboard
Monitor your EU MDR compliance score in real time with automated metrics.
Auditor Access
Share a read-only view of your EU MDR compliance status with auditors.
Related Frameworks in Healthcare & Life Sciences
Organizations using EU MDR often also need these frameworks.
HIPAA
37 documents
US federal law protecting sensitive patient health information from being disclosed without consent.
FDA
41 documents
FDA regulations on electronic records and signatures in pharmaceutical and medical device industries.
MHRA
16 documents
UK Medicines and Healthcare products Regulatory Agency framework for medical devices and pharmaceuticals.
GxP
14 documents
Quality guidelines and regulations for life sciences covering GMP, GLP, GCP, and GDP.
ICH GCP
14 documents
International standard for the design, conduct, and reporting of clinical trials involving human subjects.
ISO 13485
14 documents
Quality management system standard for organizations involved in medical device lifecycle.
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