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EU MDR Compliance Services
Learn more about the mandatory MDR standard for vendors operating across the EU and how we can help you achieve rapid, ongoing compliance in European Markets.
What is the EU MDR?
EU MDR (European Union Medical Device Regulation) is a set of regulations set out by the EU to govern the manufacturing and distribution of medical devices and ensure patient safety. The purpose of the EU MDR is to ensure any medical devices being used are safe and created to a high standard.
What are the Legislations?
For vendors that are, or anticipate becoming, a medical device manufacturer, 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 regulatory requirements for medical devices in the UK). In the UK, the latest stance on medical device reporting 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."
What are the Classifications of EU MDR?
Within the EU MDR guidelines (article 51), it states that all medical devices should be classified into one of the following categories:
Class I (low risk)
Devices that fall into this category are classed as low risk, they are non-invasive and used for general purposes.
Examples: bandages, stethoscopes, glasses
Class IIa (medium risk)
These are medium risk devices, normally with a specific intended use, and have to meet a certain safety level to be used.
Examples: hearing aids, dental fillings, catheters
Class IIb (medium/high risk)
Class IIb are classed as higher risk than Class IIa medical devices, they are often used for medical procedures and are more invasive than the lower categories.
Examples: ventilators, insulin pens, incubators
Class III (high risk)
These are classed as being the highest risk medical devices, and are required to meet strict regulations to be safe to use.
Examples: pacemakers, prosthetic heart valves, breast implants
Complying with the EU Medical Device Regulation
As part of any certification process, medical device manufacturers are required to show evidence that their products are safe to use. This includes providing 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:
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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.
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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 patient 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
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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
How can AbedGraham help with EU MDR Compliance?
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 and complete conformity assessments 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:
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An initial status review of any existing medical device documentation you may have
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Review or creation of the Clinical Evaluation Plan documentation
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Review or creation of the Post-Market Clinical Follow-Up documentation
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Review or creation of the Clinical Evaluation Report documentation
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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.
Interested in partnering with AbedGraham to ensure you are complying with EU MDR regulations? Get in touch today to find out more about how we work with vendors.
