For vendors that are, or anticipate becoming, a medical device, there are stringent requirements that they must follow to demonstrate that their devices are safe to use. Globally, these requirements can differ in nature so navigating the jurisdiction-specific compliance needs around medical devices is difficult and requires a trusted partner to do so.
In the EU, the requirements for clinical evaluation were previously laid out within the Medical Device Directive 93/42/EEC (EU MDD 1993), which were then updated in April 2017 following the publication of the Medical Device Regulations 2017/745 (EU MDR 2017). However, in the UK following Brexit, medical devices in the UK remain regulated under the Medical Devices Regulations 2002 (based on EU MDD 1993), The Medical Devices (Amendment) Regulations 2008 and are subject to enforcement under the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
However, despite this, guidance from within EU MDR 2017 has still been integrated into the MHRA's own recommendations (such as the understanding of software as a medical device (SaaMD) and the role of cybersecurity management in keeping medical devices safe in line with the essential requirements for medical devices in the UK). In the UK, the latest stance on medical device regulations is that:
"Manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the GB market until 30 June 2023. From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market."
For medical device manufacturers accessing the EU and UK market they will need to be assessed by a Notified Body (located in the EU) to receive a CE marking prior to the 30 June 2023 deadline and for the UK, the relevant conformity paperwork can be amended and submitted to be assessed by an Approved Body (located in the UK) to receive a UKCA marking as required. Navigating both these fast-changing requirements can be a difficult process to overcome.
As part of any certification process, medical device manufacturers are required to show evidence that their products are safe to use, including evidence that they comply with safety standards such as ISO 13485 (covering quality management systems) and ISO 14971 (covering risk management). A critical part of this process is the provision of a 'Clinical Evaluation' to demonstrate the characteristics and performance under normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio based on clinical data.
The evaluation of this data must follow a defined and methodologically sound procedure based on a critical evaluation of the relevant scientific literature, clinical investigations and combined clinical data currently available relating to the safety, performance, design characteristics and intended purpose of the device summarised in a set of Clinical Evaluation Documents. The minimum required documents within this set are:
A Clinical Evaluation Plan (CEP) – This document details, amongst other things, the intended purpose, target groups, benefit profile, aspects of clinical safety and progression from initial investigations to Post-Market Clinical Follow-ups.
A Post-Market Clinical Follow-Up (PMCF) Plan) – This document details the methods and procedures for collecting and evaluating clinical data including at a minimum, how safety and performance will be maintained, identifying side effects and monitoring them, identifying and analysing emergent risks and ensuring continued acceptability of the risk/benefit ratio of the product
A Clinical Evaluation Report (CER) – This document details the full overview of the appropriate literature review, the in-depth appraisal taken, how safety and performance requirements are maintained and how this is managed going forward
At the AbedGraham Group, we have reviewed or created medical device documentation for a range of small and large technology vendors. Our exclusively clinically focused team understands all aspects of healthcare and can help guide compliance for any medical device that is looking to be sold in the UK or EU marketplace.
The challenges outlined above can be extremely difficult to navigate and can waste significant amounts of time and resource if not done properly. With us as your trusted partner, we can provide any of the following to ensure ongoing compliance with any medical device regulation:
An initial status review of any existing medical device documentation you may have
Review or creation of the Clinical Evaluation Plan documentation
Review or creation of the Post-Market Clinical Follow-Up documentation
Review or creation of the Clinical Evaluation Report documentation
Ongoing support and compliance through our flexible retainer – this can include acting as the official sign-off for the documentation produced, handling questions from partners, deploying organisations or regulators and updated the document suite as required in response to changes policy landscapes