Legislation & Compliance

UN3373 legislation

Packaging and transport requirements for patient samples – UN3373

This is a Guide to the Packaging & Transportation of Biological Specimens by Road

It is not intended as a guide to classification of patient samples, which remains the responsibility of the consignor.

Interpretation of Packing Instruction 650 and the definition of the UN3373 legislation

The requirements for road transport of UN 3373 are specified in Packing Instruction 650 of ADR (The European Agreement concerning the International Carriage of Dangerous Goods by Road).

The packaging shall be of good quality, strong enough to withstand the shocks and loadings normally encountered during carriage, including transhipment between vehicles or containers and between vehicles or containers and warehouse as any removal from a pallet or overpack for subsequent manual or mechanical handling. Packaging shall be constructed and closed to prevent any loss of contents that might be caused under normal conditions of carriage by vibration or by changes in temperature, humidity or pressure.

The packaging shall consist of three components

• a primary receptacle.
•  a secondary packaging; and an outer packing.

Primary receptacles shall be packed in secondary packaging in such a way that, under normal conditions of carriage, they cannot break, be punctured or leak their contents into the secondary packaging. Secondary packaging shall be secured in outer packaging with suitable cushioning material. Any leakage of the contents shall not compromise the integrity of the cushioning material or the outer packaging.

For carriage, the mark illustrated right-hand side shall be displayed on the external surface of the outer packaging on a background of a contrasting colour and shall be visible and legible. The width of the line shall be at least 2mm; the letters and numbers shall be at least 6mm high.

The completed package shall be capable of successfully passing the drop test in 6.3.2.5. as specified in 6.3.2.3. and 6.3.2.4. except that the height of the drop shall not be less than 1.2m. The smallest external dimension of outer packaging shall be not less than 100mm.

For liquid substances:

a) The primary receptacle(s) shall be leakproof.

b) The secondary packaging shall be leakproof.

c) If multiple fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated to prevent contact between them.

d) Absorbent material shall be placed between the primary receptacles(s) and the secondary packaging. The absorbent material shall be in quantity sufficient to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging.

e) The primary receptacle or the secondary packaging shall be capable of withstanding, without leakage, an internal pressure of 95 kPa (0.95 bar).

For solid substances:

a) The primary receptacle(s) shall be sift proof;

b) The secondary packaging shall be sift-proof;

c) If multiple fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated t prevent contact between them.

Refrigerated or frozen specimens: Ice, dry ice and liquid nitrogen

a) When dry ice or liquid nitrogen is used to keep specimens cold, all applicable requirements of ADR shall be met. When used, ice or dry ice shall be placed outside the secondary packaging or in the outer packaging or an overpack. Interior supports shall be provided to secure the secondary packaging in the original position after the ice or dry ice has dissipated. If ice is used, the outside packaging or overpack shall be leakproof. If carbon dioxide, solid (dry ice) is used, the packaging shall be designed and constructed to permit the release of carbon dioxide gas to prevent a build-up of pressure that could rupture the packaging and the package (the outer packaging or the over-pack) shall be marked “Carbon dioxide, solid” or “Dry ice”.

b) The primary receptacle and the secondary packaging shall maintain their integrity at the temperature of the refrigerant used as well as the temperatures and the pressures, which could result if refrigeration were lost.

Infectious substances assigned to UN 3373 which are packed and packages which are marked following this packing instruction are not subject to any other requirement in ADR.

10. Clear instructions on filling and closing such packages shall be provided by packaging manufacturers and subsequent distribution to the consignor or to the person who prepares the package (e.g. patient) to enable the package to be correctly prepared for carriage.

11. If any substance has leaked and has been spilt in a vehicle or container, it may not be reused until after it has been thoroughly cleaned and, if necessary, disinfected or decontaminated. Any other goods and articles carried in the same vehicle or container shall be examined for possible contamination.

Royal Mail requirements:

Royal Mail will only carry UN 3373 Diagnostic Specimens if they are packed following Packaging Instruction P650, and are sent by first class post or Special Delivery and to inland addresses only.

The packet is marked with the sender’s name, telephone number and address.

TNT (Courier) requirements:

 The “Nature and Quantity of Goods” box must contain the text “Biological Substance, Category B” and “UN 3373” on the Consignment note/Air Waybill.

 The Dangerous Goods “YES” box must be ticked.

 The name and telephone number of a “responsible person” must be written on the consignment note or the package.

 The package must carry the warning symbol bearing the text UN 3373, and the words “Biological Substance, Category B”.

Referenced.GOV 2021

Unique Device Identification-UDI

Your passport to UDI compliance and a world of opportunity:

Recent FDA legislation has changed the rules for tracking and tracing medical devices, from September 2016 these rules impacted the UK and Europe where devices are manufactured for the healthcare market.

As experts in solutions for product identification and the needs of the healthcare industry Bar Code Data understands the implications this legislation has on your business, we can be there to help you determine compliance with existing opportunities.

FDA legislation now means that from the start of manufacture right through to when goods are shipped all parts are tracked and traced to safeguard quality and compliance.

All medical devices must now carry a unique device identifier or UDI label it must be readable and scanable from the point of production during shipment through the product's appropriate use and finally to its disposal.

A UDI makes important information easily accessible and helps to ensure compliance traceability efficiency and patient safety.

The supply chain begins at the manufacturer where a bar code is printed on the device or diagnostic packaging.

Device labellers also need to submit information about the product to a database administered by the FDA inside the package is a

Global Trade Item Number GTIN which makes re-ordering or diagnostic tests easier and makes the device journey easier to track.

The UDI also helps to tackle product counterfeiting and helps achieve patient safety so if there is a product issue the devices and diagnostics that need to be recalled can easily be identified.

This brings challenges, however, Bar Code Data in partnership with Zebra can help turn these challenges into opportunities.

UDI Compliance dates

Below is a summary of the compliance dates for meeting the FDA Unique Device Identification

(UDI) requirements:

24/09/2014 - The labels and packages of Class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.

24/09/2015 - The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.

24/09/2016 A Class III device required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if the

device is a device intended to be used more than once and intended to be reprocessed before each use.

24/09/2018 - A Class II device that is required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.

24/09/2020 - A Class I device, and devices that have not been classified into Class I, Class II, or Class III that are required to be labelled with a UDI, must bear a UDI as a permanent marking on the device itself if this is a device intended to be used more than once and intended to be reprocessed before each use.

GS1 standards meet all the requirements of the UDI, such as:

Product identification at each level of the packaging hierarchy

The bar code symbols to use

The product data to be included in bar codes

The data that must be stored within the Global UDI Database specified by the US FDA

Barcode Data uses partners to deliver the advantages of a secure cloud-based solution wrapped within a fixed highly cost-effective and easy-to-understand annual fee. We can help you choose the correct equipment and help design labels and label formats, giving you control to move forward with the UDI Legislation.

UDI-Device Classification 

Know Your Device Classification:

Your device falls into one of three classes of medical devices defined by the FDA. Each class of device has a different a) deadline for UDI implementation and b) type of UDI labelling that must be done. Device classes are determined by the level of risk associated with each device – the higher the class, the worse it would be if the device didn’t do its job.

Class I Devices: Lowest risk devices, like floss, gauze, and bandages.

Class II Devices: Moderate-risk devices, like syringes.

Class III Devices: Highest risk devices, like implantable devices such as pacemakers.

Implantable, Life-Supporting, and Life-Sustaining Devices: Highest-risk devices classified by the FDA for this category.

1. If you are uncertain of the classification of your device, visit the FDA’s Product Classification Database, where you can search by device name or device panel (medical speciality) to which your device belongs.

FDA Product Classification Database: Link

2. Know the UDI Deadline for Your Device

You must submit your medical device identifiers (the “DI” part of a UDI) to the FDA and incorporate your UDI (codes and proper format) into your medical device labels no later than:

Class III Devices: 24 September 2014

Implantable, Life-Supporting and Life-Sustaining Devices: 24 September 2015

Class II Devices: 24 September 2016

Class I Devices: 24 September 2018

For a complete timeline and details, be sure to read the FDA’s Compliance Dates for UDI Requirements.

FDA Compliance Dates for UDI Requirements: Link

3. Know the UDI Requirements for Your Device

The labelling standards for each medical device may vary across product lines, manufacturer sites, and business units. Depending on these factors, you may be required to implement several different UDI labels that each require their own unique format, content, and data. Even different levels of medical device packaging require distinct UDI codes and labels. Your issuing agency (the organization that assigns UDIs according to the FDA rule – either GS1, HIBCC, or ICCBBA-ISBT 128) can outline what your UDI will need based on your operations, device types, or device batching procedures.

Keep in mind that previous labelling processes may not be compliant to the new UDI guidelines. Make sure to verify your device labels for 100% compliance to your unique UDI requirements to avoid production waste, and costly compliance errors found during your manufacturing process that may result in fines and legal action if the mislabeled product is released to the market.

AutoID Legislation Solutions

Legislation (or "statutory law") is a law which has been promulgated (or "enacted") by a government or other governing body or the process of making it. Before an item of legislation becomes law it may be known as a bill and may be broadly referred to as "legislation", while it remains under consideration to distinguish it from other businesses. Legislation can have many purposes: to regulate, to authorize, to outlaw, and to provide (funds), to sanction, to grant, to declare or to restrict.

It may be contrasted with a non-legislative act which is adopted by an executive or administrative body under the authority of a legislative act or for implementing a legislative act. Under the Westminster system, an item of primary legislation is known as an Act of Parliament after enactment. Legislation is usually proposed by a member of the legislature (e.g. a Member of Parliament), or by the executive, whereupon it is debated by members of the legislature and is often amended before passage.

Recent Legislation that affects the way we manage our Goods, transportation and Logistics.

Recent (FDA) Food and Drug Administration legislation has changed the rules for tracking and tracing medical devices, from September 2016 these rules impacted the UK and Europe where devices are manufactured for the healthcare market.

Recent (FMD). Falsified Medicines Directive is happening, On Saturday 9 February 2019, the Falsified Medicines Directive (FMD) All medical devices must now carry a unique device identifier or UDI label it must be readable and scan-able from the point of production during shipment through the product-appropriate use and finally to its disposal.

Recent (TPD). The Tobacco Products Directive (TPD) sets new expectations for how the supply chain tackles issues of public health and illegal tobacco products. Whether you’re in distribution, wholesale, retail or logistics, the changes will affect you.

By May 2019, every business involved in the tobacco supply chain needs to transform the way they track and report on products.

Legislation is regarded as one of the three main functions of government, which are often distinguished under the doctrine of the separation of powers. Those who have the formal power to create legislation are known as legislators; a judicial branch of government will have the formal power to interpret legislation (see statutory interpretation); the executive branch of government can act only within the powers and limits set by the law.

Here at Bar Code Data, we have Industry partners that keep businesses ahead of the law, we can provide the solutions you need, and the equipment needed.

Our team are here to help with your specific requirements, contact our sales by email or by phone.

GENUINE SUPPLIES. ZEBRA ZIPSHIP CONSUMABLES ARE DESIGNED FOR MAXIMUM PERFORMANCE.

Zebra ZipShip is a specially selected range of supplies comprising of the most popular Zebra media products. Whether you need labels, ribbons or wristbands for your Zebra printer, we can deliver a vast range of ready-to-go supplies, all available at great prices and same-day shipment.