What does it mean to be Caldicott and MDR compliant?

Vision logistics
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At Vision Logistics, we ensure to meet high standards across all of our services. This means complying with relevant regulations in each industry.

To maintain our exceptional standards within our Healthcare Fulfilment services, we are Caldicott and MDR compliant.

These regulations have been implemented to improve patient safety, confidentiality, and product traceability within the medical and healthcare industries. Especially as products are becoming more complex with technological advancements, as a result, regulation is getting stricter and will continue to in the future.

Caldicott Principles

The Caldicott principles were developed in 1997 to protect confidential information that could identify a patient. They were also created to ensure that information is only shared and used when it is appropriate to do so. 

We comply with the 7 Caldicott principles to consistently uphold patient confidentiality. This is especially important with the technology we use in our healthcare logistics systems. Adhering to these principles means our technology and staff protect patient information at all times.

The Caldicott principles are used throughout the NHS and between non-NHS bodies. By adhering to this regulation, we can ensure our services are fully compliant and regulated within the healthcare industry. 

Our staff are fully trained and undergo refresher tuition every 6 months on the Caldicott Principles and confidentiality, ensuring that everyone is current and up to date and ensuring compliance at all times. This training is in addition to GDPR, helping us maintain the highest level of patient confidentiality and data protection, throughout our nationwide operation.

Medical Device Regulation (MDR)

The Medical Device Regulation governs the production and distribution of medical devices within Europe. MDR is a recent update of the previous regulation, MDD. Due to advances in technology, the regulation was updated to represent an up-to-date system.

As a result, new items have come under the definition and are now considered medical devices. These include contact lenses, silicone implants, high-intensity radiation equipment, dual fluid products, and many more. Medical devices being used for cosmetic reasons are now being regulated under the new MDR, meaning that some companies could be facing MDR compliance for the first time. 

In addition, when distributing medical devices, the MDR states that each device must have a Unique Device Identification (UDI). To ensure the traceability of all medical devices across Europe.

MDR aims to ensure transparency and traceability of items. Improving the digital marketplace for medical devices across Europe.

Caldicott and MDR compliant

We’ve worked hard to ensure our services are fully compliant to ensure an end to end visibility for our customers. With new technology being developed, we’re maintaining the highest standards possible to minimise disruption and keep our reliable services running smoothly.

Vision has invested in the latest 2D scanning technology to ensure batch traceability for every product throughout our nationwide operation. Also, investing in our bespoke warehouse management system to ensure compliance and peace of mind to our customers at all times.

Discover how Vision can help you with your healthcare fulfilment, please get in touch today.

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