It isn’t as simple as manufacturing and then marketing a medical device in the UK as there are plenty of compliance regulations.
There is 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 an 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.
The Medicines and Healthcare products Regulatory Agency (MHRA) 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 principal responsibilities is ensuring the safety, quality and effectiveness of medical devices in the UK
In 2016 LifeVac 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 which LifeVac has already proven to many other governing authorities around the world.
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.
Out of all the potential sectors agreed with the MHRA that LifeVac can be made available we have initially focused 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.
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, LifeVac implemented a Post Market Surveillance (PMS) process, just like every other medical device in the world. 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, in addition to this LifeVac realised early that there was a unique opportunity to capture data on choking incidents beyond that expected of a PMS report around a medical device. Which is why there are now multiple peer reviewed independent medical publications on lives saved, abstracts, safety, effectiveness, testing/research on LifeVac and comparing LifeVac to other traditional methods and ACD’s available on the market, where LifeVac was proven to be far superior in usage and effectiveness.
CE & UKCA Marking
In order to comply with relevant legislation in the UK, medical devices are required to be CE marked and display the CE logo.
At LifeVac, we didn’t want to “reinvent the wheel” and charge people for different sized devices for different age groups, which is why we source our fully CE accredited masks from very trusted suppliers who already supply thousands of hospitals and healthcare departments around the world. But the LifeVac device is also is fully CE marked/accredited meeting all CE requirements. This means customers have the peace of mind that every part of LifeVac is CE accredited and you only have to purchase one device to treat all age groups in a choking emergency.
At LifeVac we sell thousands of LifeVac devices a day and every LifeVac device goes through a rigorous quality inspection process, adhering to GMP.
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 UKCA marking, LifeVac is already UKCA marked/registered.
CE marking will continue to be recognised in Great Britain until July 2023.
The LifeVac 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).
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. LifeVac remains compliant 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. LifeVac remains compliant with the UK MDR and the accompanying UK Directives and Regulations.
The official guidance for Medical Devices are known as MEDical DEVice documents.
This guidance covers a wide range of topics including;
- Clinical assessment, rationale 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 between the manufacturer and the regulator to agree which MEDDEVs are applicable prior to deployment of any device into a market.
LifeVac has worked with the MHRA to agree on 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.