Medical device development in the UK demands a deep understanding of the safety requirements, and processes required, to offer patients reliable medical devices. These devices are used every day to help test, monitor, and treat a wide range of conditions and as such need to be manufactured to the highest standards possible. Medical device classification is the framework used to ensure these standards are met.
But what do the different classes cover and how can you ensure your product meets the rigours required? We’re going to look at the system of medical device classification in the UK and how you can ensure the reliability and success of your project by outsourcing to an expert medical device manufacturer with years of experience.
What is medical device classification?
As a standardised set of requirements for production, the classification of medical devices in the UK is covered in section 5 of the Medicines & Healthcare products Regulatory Agency under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended). This section provides the framework for determining how to categorise medical devices based on:
- Is the devise invasive/surgically invasive?
- Is it an implantable or active device?
- Does it contain a substance, which in its own right is considered to be a medicinal substance?
Once the device has been assessed it is categorised into different classes. In the UK, medical devices are classified into the following classes: I, IIa, IIb and III. These classes define what conditions are required to manufacture products to ensure that all risks are mitigated and the product performs as required.
How we support medical device development
With each level of classification there are specific production requirements that are often difficult for businesses to understand. Add to this the equipment necessary to produce medical devices and the cost and time required to produce a product can become unfeasible. That’s where we come in.
As an experienced medical device manufacturing company, we have a long history of experience with regulatory affairs and offer a comprehensive service, from medical device prototyping to manufacturing and rollout. Our state-of-the-art facilities support our ever-growing list of clients and we are perfectly placed as a resource for developing precise medical devices.
Our team is able to design and manufacture low-risk medical devices (Class I) and medium-risk medical devices (Class IIa and IIb). These are the broadest categories and cover medical devices that are administered or used outside the body. As such, most medical devices fall into these categories. Some examples include:
- Measurement and testing tools – Stethoscopes and flow sensors
- Durable medical equipment – wheelchairs and walking frames
- Single-use devices – injections and inhaled delivery devices
- Medical test kits – COVID and other at-home testing devices
The above examples are by no means exhaustive and chances are if you’re looking to design and develop a medical device, it will fit into the Class I or Class II categories. We offer support on all of the above, plus any other projects you may have, and boast a track record of over 40 years of experience in the medical device manufacturing industry. If you’d like to know more about where we can help or what category your product may fit into contact us today.
Outsourcing your medical device manufacturing
As you can see the level of knowledge required to meet regulations is extensive. This is where partnering with a trusted medical manufacturing provider, like Europlaz, can be beneficial. We work with our clients to understand what they need and provide support every step of the way.
We provide expert insight with digital prototyping and material selection to ensure your device is designed for manufacture and application. Once we have the structure in place, we get to work using the latest equipment such as 3D printers and controlled environments to ensure a fast, reliable, and replicable production chain. Finally, we carry out checks at all stages to provide complete transparency and give you the peace of mind that every product is made to exacting standards.
Whether you need a Class I or II medical device produced or just need a hand understanding of what level of production you need, our dedicated team is on hand to help. If you’d like to know more about our experience, some of the projects we’ve worked on, or how we can help you bring your medical device design to life contact us today. Our team is on hand to provide a fully-bespoke system tailored to your needs.