
September 18, 2025
How to Select the "Right" CMO Partner
Learn how to select the right CMO partner for your company's needs with ProPharma's CMO Compass tool. Avoid delays and regulatory issues by following a systematic selection process.
Following the UK's departure from the European Union, the regulatory landscape for medical devices and in vitro diagnostics (IVDs) in Great Britain has diverged from EU rules. Manufacturers must now comply with the UK Medical Devices Regulations 2002 (as amended), secure UK Conformity Assessed (UKCA) marking, and engage directly with the Medicines and Healthcare products Regulatory Agency (MHRA). ProPharma’s team of medical device experts provides regulatory consulting services to support medical device and IVD companies seeking UK market access, compliance, and lifecycle support.
Our team includes former MHRA officials and seasoned UK regulatory professionals who guide clients through every stage of the UKCA process—ensuring efficient market entry and sustained regulatory compliance.
Developing a country-specific regulatory strategy is critical to success in the UK market. ProPharma works with manufacturers to build clear, tailored roadmaps aligned with the UK MDR, classification rules, and MHRA expectations. Whether you're launching a new product in Great Britain or transitioning from CE marking to UKCA, we help define the appropriate route to market and ensure your submission and supporting documentation meet all current regulatory requirements.
Our UKCA regulatory strategy services include:
Early and proactive engagement with the MHRA can clarify regulatory expectations, especially for novel or borderline products, devices requiring clinical investigation, or those undergoing significant change. Our team assists clients in preparing for regulatory meetings and formal communications with MHRA to support classification queries, innovation advice, and clinical investigation applications.
Our MHRA support services include:
Our team of regulatory consultants partners with clients to prepare and manage regulatory submissions for UKCA marking across all device and diagnostic classifications. For higher-risk devices, we provide full support with UK Approved Body submissions, technical documentation, and conformity assessments.
Our UKCA submission services include:
Whether your product is Class I and self-declared or requires third-party review, we ensure your UKCA submission is thorough, accurate, and ready for review.
UK regulators expect robust preclinical evidence for medical devices and diagnostics entering the market. Our team helps manufacturers plan, execute, and interpret testing strategies that align with UK requirements and internationally recognized standards.
Our testing strategy support includes:
We ensure that your nonclinical evidence meets MHRA expectations and supports successful UKCA marking.
Unlike the centralized EMA model, the UK operates its own health technology assessment and reimbursement systems. ProPharma helps manufacturers navigate the NHS procurement process, prepare for NICE reviews, and explore early access opportunities.
Our UK market access services include:
We help ensure that your UK regulatory strategy aligns with reimbursement requirements to support successful commercialization.
Postmarket obligations under the UK MDR mirror many of the EU requirements but are managed independently by MHRA. Our team provides full support for postmarket surveillance, vigilance, and ongoing compliance in the UK, including:
We help manufacturers maintain UKCA certification, manage risk, and stay fully compliant with UK regulatory obligations.
Partner with ProPharma to simplify MHRA submissions, achieve UKCA compliance, and accelerate market access.
The UK’s evolving regulatory framework presents both challenges and strategic opportunities for medical device and IVD manufacturers. From changing timelines for UKCA implementation to shifting MHRA guidance and requirements for UK Responsible Persons, staying compliant requires not only technical know-how but also agile strategic planning.
At ProPharma, we bring together deep regulatory expertise, former MHRA leadership experience, and hands-on operational support to help manufacturers confidently navigate the UK medical device approval process. Whether you're entering the UK market for the first time, transitioning from CE to UKCA marking, or seeking to maintain postmarket compliance, our consultants serve as an extension of your internal team—anticipating regulatory changes, reducing risk, and accelerating timelines.
Our team of regulatory affairs and medical device experts delivers:
As the UK continues to define its post-Brexit regulatory identity, ProPharma remains a steady, informed partner who helps you make smart, compliant, and commercially sound decisions every step of the way.
Ready to bring your device to the UK market—or ensure continued compliance? Contact us today to speak with a UK regulatory expert and discover how we can support your success in the British medical device landscape.
September 18, 2025
Learn how to select the right CMO partner for your company's needs with ProPharma's CMO Compass tool. Avoid delays and regulatory issues by following a systematic selection process.
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