MethaMeasure is an Approved Medical Device

MethaMeasure Officially Recognised as an Approved Medical Device

We’re proud to announce a major milestone in MethaMeasure’s journey: as of 28 May 2025, MethaMeasure is formally registered as a Class Im Fully Regulated Medical Device with the UK Medicines and Healthcare products Regulatory Agency (MHRA). 

This recognition reflects our long‑standing commitment to safety, compliance, and high‑quality clinical software that supports community pharmacy teams across the UK.

What This Means

Being classified as a Class Im Medical Device confirms that MethaMeasure meets the stringent regulatory requirements for devices incorporating a measuring function. This includes:

  • ISO 13485 Accreditation
  • Robust quality management system
  • Accurate and reliable measurement performance
  • Full compliance with UK medical device regulations
  • Ongoing post‑market surveillance and vigilance obligations

This designation reinforces the trust placed in MethaMeasure by pharmacies, clinicians, and patients who rely on precise, safe, and compliant dispensing workflows.

MHRA Registration Details

  • Device Class: Class Im – Fully Regulated Medical Device
  • Approval Date: 28/05/2025
  • MHRA Reference Number: 35053
  • Manufacturer Registration: Listed under MethaMeasure Ltd on the MHRA Public Access Registration Database (PARD)

This public listing confirms MethaMeasure’s regulatory status and provides transparency for healthcare providers and partners.

Why This Matters for Pharmacies

Pharmacies using MethaMeasure can operate with confidence knowing that:

  • The system is recognised as a regulated medical device
  • It meets the standards required for safe and accurate methadone and supervised consumption workflows
  • It supports compliance with UK regulatory frameworks
  • It aligns with best practice for patient safety and clinical governance

For organisations focused on quality, safety, and operational excellence, this approval is a meaningful assurance.