Compliance in healthcare – new rules
If you manufacture or supply medical devices or pharmaceuticals – whether it’s locally for the NHS, the private sector or globally – there are strict new regulations you must meet in order to continue to do business.
We can help you to understand what these requirements mean for you. And what your business needs to do to meet new regulations – not to mention the benefits you can achieve in operational efficiencies and patient safety too.
Understand what regulations mean for your business
Unique Device Identification (UDI)
There’s no doubting that being able to identify, track and trace medical devices at a global level, right down to an individual patient, is important for patient safety.
All medical devices supplied into the US already require a Unique Device Identifier (UDI), with similar regulations due shortly in the EU.Find out more about UDI
Falsified Medicines Directive (FMD)
The Directive aims to prevent falsified medicines entering the supply chain and reaching patients by strengthening all aspects of the manufacture and supply chain across Europe.
The packaging on all medicines must contain a unique identifier. This is so the authenticity of prescription medicines can be verified through checking individual serial numbers against a central database.Find out more about FMD
In 2014, the Department of Health published the eProcurement strategy, ensuring that procurement efficiencies are sustained and continuously improved across the NHS.
The eProcurement strategy mandates that every hospital and every supplier of products and services into the NHS must comply with GS1 standards.Find out more about the eProcurement strategy
Education and support
We can offer you the support and guidance you need in order to meet new regulations – and to achieve so many more benefits to your organisation.
Free introductory webinars
We offer regular free webinars that explain the background to healthcare regulations and how GS1 standards ensure you comply.Book your place now
Our training provides greater understanding on how you use GS1 standards to identify devices, encode the correct production information, follow barcode best practice and manage your data to ensure compliance with Global UDI Database (GUDID).
The Directive aims to prevent falsified medicines entering the supply chain and reaching patients
How GS1 standards will deliver better patient care through efficiency and transparency