It’s been a year since faulty medical device alerts in the UK hit a four-year high.
In September 2019, the British Medicines and Healthcare Products Regulatory Agency (MHRA) recorded a four-year high in the number of alerts issued, resulting in several businesses facing the substantial costs of product recall inclusive of pricier shipping, storage, disposal and staffing costs.
However, these costly mistakes can be prevented. Significant testing, transparency and regulation adherence is vital during the manufacturing process. Working with an experienced, trusted medical manufacturing partner with the reputation and facilities to produce hi-quality products is the starting point. Each client comes with their own priorities and requirements but there are some key themes in the decision making process and reasons why customers choose Europlaz.
Location, Location, Location
British brands or companies with UK headquarters can take advantage of several benefits of manufacturing at home. The specific requirements of shape and preservation of technical parts, as well as the necessity for cleanroom packaging and sterilisation, mean that trust in the manufacturer is essential. If there is a breakdown in communication on these elements, it can be detrimental to production. Manufacturing your medical devices in the UK significantly shortens the supply chain, providing you with easy access to the entire chain should you wish to monitor progress closely, or take advantage of opportunities to conduct quality checks. A transparent supply chain will also allow you to capture and present the local nature of your brand culture and story.
Senzer is a pharmaceutical company, based in the UK, that focuses on unlocking the full potential of inhalation technologies and therapies:
“We chose Europlaz based on several reasons. The highest importance was location, we were particularly keen on having a UK manufacturing partner due to the frequency of visits that are required for a product this complex. Being located within two hours of our London office was an additional bonus.”
Using a manufacturer at home can also provide a faster turnaround, allowing your business to react quickly to market demands and regulations, and improve its production efficiency. In addition, you’ll significantly reduce the carbon footprint of your product and boost your Corporate Social Responsibility (CSR) as a result.
“Since engaging with Europlaz in late 2016 we have been impressed in the way they have delivered our complex device. There have been many challenges that were overcome through a close working relationship and skill sharing. Additionally, their intelligent approach to solving challenges has resulted in a quicker development programme”
Regulation and Compliance are two of the main reasons why customers choose Europlaz
Although BREXIT is looming, CE Marking remains an essential element of selling your product within the EEA (European Economic Area). CE marking is an indicator of a medical device’s compliance with EU legislation and is an indication of the manufacturer’s verification that the device complies with all of the relevant essential (MDD) / Safety and Performance requirements (MDR). Depending on the device classification, it also provides proof that the manufacturer has had the Technical File reviewed and approved by a notified body.
A symbol of EU safety compliance, if applied incorrectly or absent, could result in a significant fine or legal action. It is the legal responsibility of the manufacturer to ensure compliance with EU standards, and with few exceptions, to carry out product testing to demonstrate this.
Hambley Trading Limited is a company established to develop and manufacture the SINCRO, a novel single use, sterile, dental local anaesthetic syringe system:
“Europlaz have a wealth of experience in aiding companies with the design and manufacture of CE marked devices. As a small company we found this extremely helpful, especially in the design stages, and in helping to make the ideas we had for our product a reality.”
A medical manufacturer that adheres to the regulations and has certification capabilities will be able to provide you with feedback on production possibilities, from the initial conceptual form to the final design, so that the end product meets the regulatory requirements satisfactorily.
“By working with Europlaz we were able to produce a product that worked with all styles of carpule and also respond to the changes in regulatory demands which happened throughout the design time-period.”
We strongly believe that our ability to guide clients through the CE Marking process is one of the main reasons why customers choose Europlaz.
First Class Facilities
Our cleanroom manufacturing facilities are accredited to ISO 14644-1 Class 7 and specifically designed for processing class I and class II medical devices to ensure first class standards are met and quality is controlled. This is particularly important when it comes to the manufacture of critical medical devices and is one of the main reasons why customers choose Europlaz. Within our 7 accredited cleanroom facilities, we are able to carry out complete assembly, injection moulding and packaging solutions.
The right medical manufacturer will support you in resolving any technical issues and provide a working partnership that keeps the dialogue open and collaborative. This was particularly important for our long-standing client, Fresenius Kabi.
Fresenius Kabi, a global healthcare company, knew who to talk to when they decided to stop buying ready assembled components from the USA and design and manufacture their own parts with a trusted British company.
“Europlaz encouraged us to take an active role in the redesign and manufacture of the spike assembly and we felt that we were very much in control in the progress of our project. Their innovative solution to a difficult technical challenge means that we can provide our customers with a better product.”