The UK’s MHRA aligns with ARC Research Laboratories on Health Institution Designation

ARC Laboratories has now received formal notification from the UK Regulator for Medicines and Medical Devices that Northern Ireland based Health Institutions can conduct testing of EU and UK patient samples for Clinical Trials under the IVDR Health Institution Exemption (Article 5(5)). After our alignment with the MHRA in 2025, ARC Laboratories meets the definition of a Health Institution as outlined in the IVDR, which applies in Northern Ireland.

This designation enables faster, more flexible start-up and execution of clinical trials that involve EU patients, helping sponsors expand their trials into Europe, reduce timelines, manage costs, and accelerate precision medicine programmes more efficiently within the EU.

How this benefits our clients:

Health Institution status allows ARC Research Laboratories to manufacture and use in-house devices in Precision Medicine Clinical Trials for specimens originating in the EU, without requiring a Performance Study Application and subsequent Competent Authority approval.

As a result, we can offer:

• Full Compliance with Article 5(5) of the IVDR
• In-house test development
• Assay protocol transfers
• Faster project timelines
• Reduced costs
• Enhanced flexibility to adapt tests for specific clinical and patient needs
• Greater innovation through internal development and validation of novel diagnostics

What sets ARC Research Laboratories Apart:

ARC maintains rigorous quality and regulatory standards, including:

• Implementation of a robust Quality Management System (QMS) aligned with ISO 13485 and ISO 14971 for product realisation and risk management
• Assay verification and validation meeting IVDR General Safety and Performance Requirements (GSPRs)
• A QMS in compliance with ISO 15189, CAP and CLIA
• Sample testing conducted in full compliance with IVD medical device GCP, ensuring that your study data is robust and reliable and that the rights, safety and welfare of patients is protected

What Validated Technologies are Available at ARC Research Laboratories:

• Histopathology
• ELISA
• Next Generation Sequencing
• qPCR

Get in touch with our team to learn more: [email protected]