MHRA Medical Device Label

Ardens Clinical is registered with the MHRA as a Class I medical device, registration numbers 8501 (EMIS) and 8598 (SystmOne). Relevant steps have been taken to CE mark this product.

Caution: Misuse of these tools may result in incorrect diagnosis or treatment of patients, with severe impact on their health, including serious injury and death.

Introduction

Ardens Clinical is a set of templates and tools that support clinical decision making. Ardens Clinical tools exist within [EMIS / SystmOne], and provide support based on information entered by a clinician and existing data from the patient record.

Intended Purpose

Ardens Clinical tools are designed to inform and support a user’s decision making and improve patient care. They are integrated into [EMIS / SystmOne] to provide a service that is accessible from within the patient record environment.

Users should read Ardens Clinical documentation before using these tools, and understand the limitations of the software.

Users must complete relevant training before use of these tools.

Any information displayed by Ardens Clinical is a guide only, and does not replace clinical decision making. Content is regularly checked against NICE and other relevant guidance, but Ardens cannot assure that information is the latest guidance. Clinicians should use their own knowledge and judgement.

Intended Users

The intended users of Ardens Clinical tools are primary care staff who are suitably qualified to practice in the UK. The templates must not be used by anyone else for any purpose.

Safety Information

Ardens intend that only suitably trained staff should make use of Ardens Clinical tools. These should form part of, but not the totality of, the decision making process. All clinicians are responsible for the outcomes of their actions, regardless of use of Ardens Clinical tools.

Ardens Clinical:

• is designed for use in primary care settings, such as GP surgeries

• should ONLY be used by appropriately qualified and registered staff

• is NOT intended to diagnose patients with any condition

• is NOT designed to replace a clinician’s own judgement as to what course of action to follow with a patient

• should NOT be used as the sole means of determining the frequency and dosage of drugs to prescribe

Documentation

Ardens maintain a clinical safety case and hazard log for Ardens Clinical tools. These can be viewed on request.

Ardens training materials can be found here.

Ardens terms and conditions can be found here.