Clinical Investigations UK

Maria
Apr 20
2 min read

Clinical Investigations for Medical Devices in the UK: What You Need to Know

For medical device manufacturers looking to access the UK market, understanding the clinical investigation framework established by the Medicines and Healthcare products Regulatory Agency (MHRA) is essential. Clinical investigations are critical for generating clinical evidence, especially for non-CE/UKCA marked devices or those undergoing significant changes.

In this article, we summarize MHRA’s expectations and show how AF Pharma, as your trusted UK Responsible Person (UKRP), supports full compliance from clinical study submission through post-market responsibilities.

When Is a Clinical Investigation Required?

A clinical investigation is generally required when:

Your medical device does not have a CE or UKCA mark.
You are conducting studies to support the UKCA marking process.
You plan to make significant changes to an existing device that may affect its safety or performance.
The device is a Class III or implantable Class IIb device requiring robust clinical data.

Clinical investigations are not mandatory for CE-marked devices that are not being modified and already have sufficient clinical data—although post-market follow-up may still apply.

Key Regulatory Requirements

The MHRA requires manufacturers to submit:

A CI application form (per Part 2 of the UK MDR 2002).
The investigator’s brochure, protocol, participant information, labeling, and risk analysis.
Evidence of ethical committee approval (REC).
Proof of insurance/indemnity cover.

Once submitted, the MHRA aims to provide feedback within 60 days. Sponsors may begin the investigation only after MHRA and REC approval, and only if no objection is raised.

Ongoing Responsibilities

Once your study is approved:

You must register the trial in a publicly accessible database (e.g., ClinicalTrials.gov).
Annual progress reports, serious adverse event reports, and notification of study termination are all required.
A final report must be submitted to MHRA and REC within 1 year of study completion.

AF Pharma

At AF Pharma, we offer cost-effective, personalized support as your UK Responsible Person (UKRP). Our London-based office ensures that your clinical investigations and device registrations comply fully with MHRA requirements.

We provide:

UKRP services for £1,100/year (flat fee per company).
Seamless handling of clinical documentation and MHRA communications.
Optional support for technical file creation or remediation, with your first year of UKRP services free when bundled.

We specialize in supporting startups, SMEs, and international manufacturers entering the UK market. With AF Pharma, you gain both a regulatory ally and a strategic partner.

Ready to Launch Your Clinical Study in the UK?

Don’t navigate the UK regulatory landscape alone. Partner with AF Pharma to ensure your clinical investigation meets all MHRA requirements—efficiently and affordably.

📧 Contact us at info@afpharmaservice.com

🌐 Visit www.afpharmaservice.com

📍 Based in London, serving clients worldwide