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Before you can put a device on the market…
You cannot simply manufacture and then market a medical device in the UK
There are a multitude of requirements and which ones apply depend on the intended use of the device, function, manufacture and others.
There are also a multitude of organisations that have in interest in the public’s health and safety including the NHS, CCGs, PHE, DHSC, CQC, HSE, FSA and many others.
In regards to medical devices in the UK the overriding responsibility lies with the Medicines and Healthcare products Regulatory Agency, the MHRA
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MHRA
The Medicines and Healthcare products Regulatory Agency regulate medicines, medical devices and blood components for transfusion in the UK
You will probably have heard the MHRA mentioned when discussing their role in ensuring Covid vaccinations are safe and authorising their use in the UK
The MHRA are an executive agency of the UK Government within the Department of Health and Social Care (DHSC)
One of their three principle responsibilities is ensuring the safety, quality and effectiveness of medical devices in the UK
In 2017 Dechoker completed and submitted a clinical evaluation to the MHRA as part of the UK MDR 2002 requirements.
This sets out both the rationale, clinical benefit over existing methods of treatment, and most of all – safety.
The following stage was to submit and agree a proposal with the MHRA to make the device available in the UK.
Again this included the rationale for the sectors chosen, implementation of training, monitoring via a PMS and a framework for deployment.
Off all the potential sectors agreed with the MHRA that Dechoker can be made available we have initially focussed on the Adult Care Sector.
With a significant number of choking deaths within the elderly cohort and an existing Adult Care framework this was deemed the most suitable.
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Post Market Surveillance
Conformity to the requirements for the deployment of any CLASS I medical device in the UK requires a level of surveillance to be carried out by the manufacturer.
Prior to any deployment Dechoker UK implemented a Post Market Surveillance (PMS) process. This also incorporates vigilance procedures to identify the potential need for corrective action.
The PMS includes a process to systematically review experience gained in the post-market phase (in the field) by way of a data capture after usage.
Post usage of a Dechoker ACD in a choking emergency, those involved in the incident complete a questionnaire via a secure web portal which captures anonymised data.
Dechoker UK realised early that there was a unique opportunity to capture data on choking incidents beyond that expected of a PMS centred around a medical device.
The additional data and the amount generated allowed an NHS Trust to complete a comprehensive study of 27 life-saving incidents where a Dechoker has been used in a choking emergency.
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CE & UKHCA Marking
In order to comply with relevant legislation in the UK, medical devices are required to be CE marked and display the CE logo.
Dechoker is the only ACD that is fully CE marked as a complete system. This ensures we test a complete kit and do not rely on 3rd party components.
Since 1 January 2021, there have been some changes introduced on how medical devices are placed on the market. One of these is the planned replacement of the CE mark with the UK’s own UKHCA marking.
As a new process established as a result of the UK leaving the EU it is still being rolled out. Dechoker UK are currently working with their Approved Body to achieve the UKHCA mark within the timeframe set out by the MHRA
CE marking will continue to be recognised in Great Britain until July 2023
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CLASS I
The Dechoker ACD is a CLASS I medical device as described in Part II of the UK MDR 2002, Annex IX (as modified by Part II of Schedule 2A to the UK MDR 2002)
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EU MDD & UK MDR 2002
EU MDDs or Medical Device Directives are / were designed to harmonise the laws across the EU in relation to medical devices. Dechoker was and remains compliant to with EU MDD and the accompanying EU Directives and Regulations
UK MDRs or Medical Device Regulations are specific to the UK and draw from the EU MDD. With the UK leaving the EU changes to the UK MDR are planned. Dechoker is and remains compliant with the UK MDR and the accompanying UK Directives and Regulations
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MEDDEV
The official guidance for Medical Devices are known as MEDical DEVice documents.
This guidance covers a wide range of topics including;
- clinical assessment, rational and evaluation,
- safety and Post Market surveillance,
- requirements of conformity to relevant standards and legislation.
MEDDEVs are used by manufacturers, Notified Bodies, Competent Authorities and regulators such as the MHRA to ensure the safe and regulated introduction of medical devices.
Not all MEDDEVs are applicable to a device or device type. It is the between the manufacturer and the regulator to agree which MEDDEVs are applicable prior to deployment of any device into a market.
Ahead of the first device being introduced Dechoker UK first worked with the MHRA to agree which MEDDEVs were applicable.
Once these had been completed, they were subsequently agreed with the regulator.
Some of the principle considerations have been outlined here, with a particular focus on those that are queried most often.
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Dechoker ACD
The Dechoker ACD – Airway Clearance Device – has been developed for use in a choking emergency when existing Basic Life Support techniques have failed.
When a person’s airway is obstructed and they cannot breathe – either with food or another object – then time is absolutely critical. The hand-held Dechoker creates directed suction over the airway and is designed to remove food, liquid or other obstructions.
