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Best Practice Guidance for UDI Compliance – published in Med-Tech Innovation

By Warren Stacey The system means that by 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information. READ THE FULL ARTICLE HERE PAGE 24/25  

Labelling Matters

By Mark Cusworth While not front of mind in drug development, the packaging and, in particular, labelling of medicines are the final pieces of the puzzle. Inaccessible products can have serious implications on patient adherence, costing the industry billions.

A Surprise Package

By Mark Cusworth As global healthcare grapples with the problem of medication adherence, C Everett Koop’s famous observation has become a familiar retort: “Drugs don’t work in patients who don’t take them”. The same concept applies in clinical trials; they are often unsuccessful when patients do not comply with their medication regimes. Furthermore, if the cost of recruiting patients to studies is high, the price of failing to keep them there is even higher.

Develop a Strategy to Ensure Compliant Labeling Inspection

With half of all medical device recalls in recent years caused by packaging and/or labeling errors, it’s time for manufacturers to rethink their approach to labeling inspection.

Compliant Labeling Inspection: Strategies for Success

The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers. Understandable concerns about the cost and consistency of new technologies has convinced many companies to maintain traditional methods of labeling inspection –

Labelling compliance – what you need to know

In September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use.

Examination of UDI Implementation and Lessons for Manufacturers of Class II Devices

Almost two and a half years after the FDA issued its final rule on a Unique Device Identification system, the clock is ticking relentlessly towards the next critical deadline in the timetable for its compulsory introduction. By September 2016, the labels and packages of all Class II medical devices must bear a Unique Device Identifier (UDI) – and data for such devices must be submitted to the FDA’s Global Unique Device Identification Database (GUDID). The implications for medical device companies are significant.

Our UDI opinion article was published by PMPS

In September 2013, the FDA set out its framework for establishing a unique device identification system to track medical devices through their distribution and use. The system, which is being phased over several years, means that by 2020 most medical devices will need to include a unique device identifier (UDI) in human- and machine-readable form.

Prisym ID to Attend Informa's Pharmaceutical and Medical Device Labelling Summit

PRISYM ID, the leading provider of labeling solutions for the medical device and life sciences industries, is exhibiting on Stand 6 at the Informa Pharmaceutical Labeling Conference. The event takes place between the 27th and 28th October 2015 at the Maritim ProArte Hotel Berlin, Germany.

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