Clarity Pharma gets to grips with UDI implementation in the UK
Clarity Pharma, a prominent UK headquartered consultancy and distribution partner to mid-market pharmaceutical companies, is calling on the industry to prepare for the imminent introduction of Unique Device Identification (UDI).
Every product manufactured in the global health care industry will soon have to provide item-level serialisation, which will enable enhanced product identification, traceability and greater emphasis on patient safety within the medical device industry.
UDI is a unique number or alphanumeric code that consists of two parts: a UDI-DI (device identifier) and a UDI-PI (production identifier). The DI element of the code identifies the specific version or model of a device, through a GSI barcode or datamatrix, whilst the PI element gives production data – typically batch code, lot number, expiry date or date of manufacture. It is critical that the information is presented in two forms for both human and machine interfaces.
“UDI will make it quicker and easier to identify and track products in the supply chain, from supplier to patient. Patient care is the number one priority for both the MHRA and NHS and UDI’s will ensure that patients are safeguarded through increased vigilance and quicker corrective action, while industry and regulatory authorities can quickly identify and target products for safety alerts and recalls. End-to-end traceability is also ensured. This will serve as an anti-counterfeiting measure and positively impact on operations, supply chain and warehousing to allow easier business operations, inventory management and accounting,” explains Max Trebilcock, UK Medical Device Responsible Person.
Under the new European Regulations (EU MDR 2017) the UDIs manufacturer submits the code to a central database, so that it can be checked at various stages in the supply chain, via a scanner or smart phone. It is anticipated that MHRA will follow suit and expand its Medical Device Registry to include UDI-DI as a minimum step.
Organisations should also be accurately identified by an MHRA recognised, but standard, unique Actor ID. This will improve the traceability of products and ensure compliance with regulation as a critical patient safety measure. It will also enable the faster recall and removal of unsafe products and could soon be a requirement by healthcare providers such as the NHS.
With The Medicines and Medical Devices Act now legislated in the UK, the MHRA is expected to issue new regulations for future device identification and identification of medical device Economic Operators or actors in Great Britain in 2003.
Ahead of the new regulations, UDI-DI was added to UK MDR 2002, under appendix in 2019. Currently the NHS includes UDI-DI on their device registration submissions, so traceability is fast becoming an industry standard well ahead of new UK MDR going live.
An additional challenge for the UK medical device supply chain are companies who supply devices to both Northern Ireland and mainland UK. Under the Brexit Agreement, Northern Ireland remains under the EU MDR 2017 with the full requirements for both UDI-PI and DI.
“By mid-September, the MHRA has started its public consultation of all medical device manufacturers, wholesalers, distributors, suppliers, healthcare provider organisations, and solution providers to share input,” Trebilcock points out. “With the MHRA releasing its public consultation to address the future of UDI regulation, it offers a unique opportunity for all healthcare stakeholders to help shape the future of UDI regulation in Great Britain.”
Clarity can adapt their systems to implement these new elements of traceability into practice. “By putting your product into one of our credible warehouses, with our proven tracking systems and processes, coupled with MHRA and Home Office licensing, you can be confident that should there be a problem we will interact with the MHRA on your behalf. This is just one of the crucial distinctions between health care enabled providers like Clarity and generic warehouse facilities,” Trebilcock concludes.
Clarity Pharma offers a comprehensive range of services to global firms wanting to enter the UK healthcare market. These include Medicines and Healthcare Products Regulatory Agency (MHRA) approval and Home Office Controlled Drugs Licensed warehousing and logistics, coupled with technical and regulatory compliance capability. If you require any information on how to become UDI compliant, contact the Clarity team for advice.