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When a company is introducing a new medical device or updating an existing one, it's crucial to make sure it has the necessary regulatory approvals before it can be used by people or sold for general sale.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is in charge of regulating medical devices. They oversee the approval process to ensure that devices are safe, effective, and comply with the relevant laws. This article explains the approval process in the UK, covering the requirements for CE marking and compliance with the Medical Device Regulation (MDR), along with a brief overview of the certification process.
Brief Overview:
The 4 steps to gaining regulator approval for medical devices in the UK:
1. Classification
2. Conformity Assessment
3. Medial Device Regulation (MDR)
4. CE Marking (or UKCA)
Registration with a Notified Body:
Before applying for approval, a company should be registered with a notified body. Once certified, you can then register your medical device or range of devices.
Device Classification:
Medical devices are grouped into four classes based on their risk level. Class I devices are low risk (such as a non electric wheelchair, bandages, or a handheld surgical instrument), Class IIa & IIb are medium risk (such as a tracheotomy tube, dental filling, or a lung ventilator, while Class III devices are high risk (such as a pacemaker or heart valve).The device's classification determines the level of regulatory control and the type of conformity assessment needed.
Conformity Assessment:
After classification, manufacturers must perform a conformity assessment to prove the device meets essential requirements. Different routes for conformity assessment are available, depending on the device's classification. These can include self-certification, third-party assessment and full quality assurance. This is the point where Aderico Medical get involved. We work with the manufacturer or third party company by finding participants to assess the device, to prove that the product meets essential requirements.
CE Marking:
Following the conformity assessment, manufacturers apply for CE marking, confirming compliance with relevant legislation. CE marking is a legal requirement and must be affixed to the device or packaging, indicating compliance but not guaranteeing quality or safety. A CE marking on a device enables the product to be placed on the EU/EEA market. There is also a separate route to market and product markings for manufacturers wishing to place their medical device on the Great Britain market called UKCA marking.
Meeting Medical Device Regulation (MDR):
Implemented in May 2021, the MDR replaced the Medical Devices Directive (MDD). It introduced stricter rules for classification, conformity assessment, and post-market surveillance. Class III devices and certain Class IIb devices under the MDR must be assessed by a notified body (independent organisations designated by the MHRA to assess the conformity of medical devices with the essential requirements of the legislation).
Post-Market Surveillance and Clinical Evidence:
The MDR introduced new requirements for post-market surveillance and clinical evidence, which means that manufacturers must monitor devices post-market, report adverse events, and gather clinical evidence supporting safety and effectiveness.
Additional Approvals:
Besides MHRA, other regulatory bodies like the National Institute for Health and Care Excellence (NICE) and Health and Safety Executive (HSE) may require approval for reimbursement and workplace safety.
Conclusion:
The UK's medical device approval process is thorough and complex, aiming to ensure patient safety and device effectiveness. Manufacturers must follow a series of steps, including classification, conformity assessment, and CE marking, with the recent introduction of the MDR adding stricter rules for compliance and monitoring. Following these requirements ensures that medical devices meet high standards of quality, safety, and effectiveness.
Aderico Medical can assist any device manufacturer or third party assessment agency by recruiting participants at any stage of the approval process. Unlike other recruitment agencies who rely on a static database of pre-determined participants, the Aderico Medical team actively go out and find the exact participant profile required for studies.
