MHRA Regulatory Framework
UK Medicines and Healthcare products Regulatory Agency framework for medical devices and pharmaceuticals.
Quick Facts
- Documents Included
- 16
- Category
- Healthcare & Life Sciences
- Regions
- European Union / UK
- Compliance Domains
- 4 domains
What's Included
SeedGovernance provides 16 ready-to-use templates for MHRA, covering 4 compliance domains. Each document is pre-filled with framework-specific guidance so you can start immediately.
Device Registration
Policies, processes, and evidence templates
Vigilance
Policies, processes, and evidence templates
Clinical Investigations
Policies, processes, and evidence templates
GMP Compliance
Policies, processes, and evidence templates
How SeedGovernance Helps with MHRA
Beyond templates, our platform guides you through every step of MHRA compliance.
Assessment Wizard
Answer guided questions to assess your MHRA readiness and identify gaps.
Gap Analysis
Automatically surface what's missing from your MHRA compliance programme.
Document Library
16 pre-built templates tailored to MHRA requirements.
Operations Modules
Track incidents, changes, risks, and vendors — all mapped to MHRA controls.
KPI Dashboard
Monitor your MHRA compliance score in real time with automated metrics.
Auditor Access
Share a read-only view of your MHRA compliance status with auditors.
Related Frameworks in Healthcare & Life Sciences
Organizations using MHRA 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.
EU MDR
18 documents
EU regulation governing the production and distribution of medical devices in the European market.
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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