UK & EU Regulatory Strategy and Compliance

Discuss Your Regulatory Strategy

If you would like to explore how MedTec Consulting can support your regulatory pathway, we welcome an initial conversation to understand your technology and objectives.

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If you are developing a medical device, SaMD or AI-enabled technology and would like to understand how regulatory architecture can support your growth, we would be pleased to hear from you.

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We work with innovators developing complex, high-impact medical technologies. If you would like to discuss your regulatory pathway and determine whether our expertise aligns with your needs, we welcome an initial discussion.

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Regulatory Strategy

Technical Files

Risk Management

QMS Design

UKRP Services

Market Access

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EU & UK Regulatory Strategy and Compliance

MedTec Consulting provides regulatory and quality support across UK MDR 2002, EU MDR 2017/745 and EU IVDR 2017/746.

We support manufacturers of medical devices, SaMD, AI-enabled devices and in vitro diagnostics through regulatory classification and pathway planning, Technical Documentation development, risk management, clinical and performance evaluation, and post-market surveillance.

Our work goes beyond document preparation. We build structured, audit-ready regulatory frameworks aligned with your product strategy, intended use and route to market.

Operating under our own ISO 13485-aligned quality framework, we provide end-to-end regulatory support, including UK Responsible Person (UKRP) services, MHRA device registration and coordination with Approved Bodies and Notified Bodies where required.

Technical Documentation & Lifecycle Support

We specialise in developing robust Technical Documentation structured to meet UK and EU regulatory requirements.
Our support includes:

Regulatory classification and conformity pathway planning
Technical Documentation development aligned with applicable legislation
Risk management in accordance with ISO 14971
Software lifecycle compliance (IEC 62304)
Clinical Evaluation (MDR) and Performance Evaluation (IVDR)
Post-Market Surveillance and PMCF systems
QMS gap analysis and regulatory remediation

Our focus is not simply obtaining a CE or UKCA mark – it is building regulatory systems that withstand scrutiny and support scalable, sustainable market access.

Integrated Quality & Management Systems

MedTec Consulting supports manufacturers in building and strengthening management systems aligned to:

ISO 13485 (Medical Device Quality Management Systems)
ISO/IEC 27001 (Information Security Management Systems)
ISO/IEC 42001 (AI Management Systems)

For software and AI-enabled medical devices, regulatory compliance increasingly overlaps with information security, data governance and algorithmic oversight. We support clients in building integrated, proportionate systems that align regulatory obligations with operational reality.

Our approach focuses on practical implementation – ensuring systems are audit-ready and scalable.

CE and UKCA Marking Strategy

We support manufacturers seeking conformity under:

UK MDR 2002 (as amended)
EU MDR 2017/745
EU IVDR 2017/746

Whether self-certified or requiring third-party conformity assessment, we guide clients through the appropriate conformity route, ensuring Technical Documentation and quality systems align with regulatory expectations.

UK Responsible Person (UKRP) Services

For non-UK manufacturers placing devices on the Great Britain market, appointment of a UK Responsible Person (UKRP) is required under UK MDR 2002.

MedTec Consulting provides UKRP services as part of our broader regulatory offering, ensuring registration, vigilance coordination and technical documentation availability obligations are met in a structured and transparent manner.

MHRA Device Registration Support

All devices placed on the Great Britain market must be registered with the MHRA prior to commercialisation.

We support clients with accurate and efficient device registration, ensuring alignment between regulatory status and Technical Documentation.

Regulatory Review Insight

Our team brings experience working with and auditing conformity assessment bodies operating under ISO/IEC 17021 and ISO/IEC 17065 accreditation frameworks.

This insight informs how we structure Technical Documentation and quality systems – ensuring they are designed to withstand real-world regulatory review.

Regulatory-Aligned Market Access Strategy

Successful medical technologies require both regulatory compliance and demonstrable system value.
We support clients in aligning regulatory strategy with NHS adoption and reimbursement considerations, including:

NHS service and pathway positioning
Budget Impact Model development
Business Case preparation for Trust-level adoption
NICE HealthTech evaluation and evidence alignment support

Our focus is ensuring that clinical, regulatory and value evidence are developed coherently – reducing duplication, strengthening investor confidence and supporting sustainable long-term market access.

Strategic Introductions

Through established relationships across regulatory, clinical and industry communities, we facilitate selective introductions where appropriate.

Introductions are made thoughtfully and only where they support regulatory progression, evidence development or long-term growth.