UK MDR/EU MDR Compliance
Ensuring Regulatory Compliance for Innovative HealthTech
Medical Device Regulation
MDR Compliance for Digital Health
Digital Health manufacturers must navigate complex regulatory requirements to ensure their products comply with both UK and EU medical device regulations.
Here’s what you need to know:
UKCA/CE Marking Requirements
Digital Health manufacturers must:
- Demonstrate compliance with medical device directives and regulations
- Register software as a specific class of medical device
- Complete required assessment processes and documentation
Currently, CE marked devices with valid certificates are recognised in Great Britain until 30th June 2028 at the latest, depending on the device type and applicable legislation.
Key Compliance Activities
Documentation and Reporting
- Declaration of conformity
- Technical documentation production and maintenance
- Clinical evaluation plans and reports
Ongoing Compliance Management
- Post Market Surveillance & Vigilance
- CAPA management
- Integration with DCB 0129 NHS safety standard
Quality Assurance
- Quality Management Systems
- ISO 13485 internal audit and compliance management
Regulatory Strategy and Support
- Responsible person for regulatory compliance
- Regulatory Compliance strategy development
- UKCA/CE marking assistance
Harmonised Standards
Digital Health manufacturers should be familiar with key standards:
- ISO 13485 – Quality Management System – Medical Devices
- ISO 62304 – Software lifecycle
- ISO 14971 – Risk Management
Regulatory Landscape
The UK is developing its own regulatory framework for medical devices, with the MHRA aiming to introduce new regulations that prioritise patient safety and align with international practices.
The roadmap released in January 2024 outlines plans for priority measures to be in place this year and core regulations to be introduced in 2025.In the EU, the Medical Device Regulation (MDR) replaced previous directives and entered into force on May 26, 2021.
The EU has extended transition deadlines for certain device classes to address implementation challenges.
Market Access Expertise
Our team’s market access expertise enhances your ability to successfully introduce and maintain your Digital Health products in both UK and EU markets:
Market Entry Strategy
- Tailored approaches for UK and EU markets
- Guidance on market-specific requirements and timelines
Reimbursement Pathways
- Understanding of NHS and EU healthcare systems
- Support in navigating reimbursement processes
Stakeholder Engagement
- Identification of key decision-makers and influencers
- Strategies for effective communication with payers, providers, and patients
Health Technology Assessment (HTA)
- Preparation for HTA submissions
- Development of value propositions aligned with market needs
Post-Market Requirements
- Ongoing compliance with market-specific regulations
- Strategies for maintaining market position and expanding reach
Expert Guidance
Navigating the complex and evolving regulatory landscape requires expertise.
Our experienced team offers:
- Guidance through the compliance process
- Tailored support, from advice to complete process management
- In-depth knowledge of both UK and EU regulatory requirements
- Comprehensive market access strategies
Ensuring compliance with UK MDR and EU MDR is crucial for Digital Health manufacturers.
By staying informed about regulatory changes, leveraging market access expertise, and working with experienced professionals, you can navigate the compliance process effectively and bring your products to market successfully.
