Preparing for the EU medical device regulation
The term 'medical device' is broad and covers a wide range of items. It is referred to most commonly as an apparatus or a piece of equipment that is used to treat or diagnose a condition that comes into direct contact with the patient. Whether it is a simple pair of contact lenses or a more sophisticated device, such as a pacemaker, the frequency with which we encounter medical devices in our day-to-day lives is surprisingly high and the key role they play in our well-being remains undeniable.
It is because of this role that regulations surrounding medical devices tend to be placed under more stringent scrutiny. Under the US Food and Drug Administration rule in the USA, manufacturers have been required to implement UDI (unique device identification) on all medical product packaging since September 2014. Following this, and in light of the recently adopted EU Medical Device Regulation, European manufacturers of medical devices will face tougher regulations to ensure that their products are safe to use under new EU laws that are scheduled to come into effect on 26 May 2020.
The new regulation will also see the introduction of a new, unique device identification system. This means that, for traceability purposes, medical devices sold in EU member states will need to include a code, also known as a unique device identifier, of which the details will be recorded in an EU database.
With these laws coming into effect, manufacturers now have a legal responsibility to invest in a solution that allows them to apply traceability codes onto products as well as their packaging.
As a global leader of high quality coding and marking solutions, Domino Printing Sciences is well placed to help these manufacturers meet the emerging requirements. The following white paper aims to identify the coding applications encountered most often in the medical industry and highlight the ways in which different coding and marking technologies are equipped to tackle them.
Common medical devices will be affected by the new regulation
Based on manufacturer prices, the European medical technology market is worth j110 billion and is estimated to make up 28% of the world market, making it the second largest in this sector after the USA. There are approximately 25,000 medical technology companies in Europe, with more than 575,000 registered employees. Market research reveals that small and medium-sized companies (SMEs) make up almost 95% of the EU industry and that the majority of them employ fewer than 50 people per company.
The current rules relating to the safety and performance of medical devices in the EU date back to the 1990s. However, the substantial scientific and technological advances in the medical sector that have taken place since their implementation have prompted the EU Commission to update the rules. The view is to improve the safety and performance of medical devices for EU citizens, while also creating the conditions to effectively modernise the sector and further consolidate the European Union’s role as a global leader. To fully appreciate the impact that the legislation rollout will have on the EU medical sector in the near future, it is important to understand in what categories medical devices can be classified in the following categories:
The technology to assign, apply and verify identification codes to a wide range of products is an invaluable asset. The benefits are varied and apply to numerous industries such as the medical sector, in which UDI is the accepted method for identifying and tracing medical devices throughout their lifecycles, from production through to distribution and finally to consumer use.
The implementation of product codes onto medical devices results in more efficient recall procedures, the reduction of medical errors, as well as increased inventory visibility and supply chain security. The unique codes applied to each item during the manufacturing stages will provide the supply chain management system with key information, such as what the product is, where and when it was produced, its current location and how it got there. Should a recall become necessary owing to a product being faulty, the code is crucial to unlocking the so-called “chain of custody,” allowing the item in question to be traced back to its origin.
As is the case with other industries, counterfeit products can harm a medical brand in many ways, from affecting business revenues to destroying consumer faith in the brand through poor-quality imitations. More importantly, counterfeit products can endanger consumer health. Illicit trade can be even more detrimental, as it goes beyond simple counterfeiting to encompass equally damaging activities such as product diversion, when perfectly genuine products are deflected from intended channels into ones unauthorised by the manufacturer. With this in mind, item-level identification proves to be effective in helping to distinguish legitimate products from the counterfeit ones, while also helping governments to stem the erosion of revenues and jobs caused by illicit trade.
With the new EU regulations coming into play, medical device manufacturers have a legal requirement to ensure that a UDI code is applied on every single item they produce by the May 2020 deadline, whereas a May 2021 deadline will be in place for class III medical devices.
Common medical devices will be affected by the new regulation
Failure to comply with the legislation will have negative repercussions. Manufacturers will no longer be able to supply their products to other EU member states. Fee payers and healthcare providers will not accept devices without UDI codes that are up to the required standard.
As a result, manufacturers now face a responsibility to familiarise themselves with the exact requirements of the legislation and ensure they have a coding and marking solution in place that can meet their needs — ahead of the stipulated deadline. However, to understand these requirements, a comprehensive audit and evaluation of the technologies available on the market is needed.
Depending on the medical device and the coding surfaces involved, there are several different technologies that can be deployed for the delivery of UDIs in this sector.
The most prominent of these technologies is fibre laser, a solid-state laser system that is primarily used for direct part marking (DPM). Although DPM is more commonly known as an industrial manufacturing application, it is most appropriate for medical device identification. The presence of reprocessing devices throughout the supply chain can cause product items to be separated from their intended packages, which is why a permanent mark needs to be applied to the medical device. This way, a UDI code is readily available through the device’s distribution and use, even in the absence of packaging or labels. Medical devices such as pacemakers or surgical instruments are the kind of products that would require a permanent mark, as the UDI is designed to last as long as the device itself.
With code durability being the key priority, a fibre laser marker is the preferred solution — provided the required contrast can be achieved. A solid-state laser system can permanently mark a variety of materials with the utmost precision, producing unlimited lines of texts, graphics or even 2D data matrix codes, resulting in crisp, sharp codes that will not deteriorate with time.
In contrast to DPM, a variety of coding and marking technologies, as well as fibre laser, can be used to apply unique device identifiers onto primary packaging. These technologies include Thermal Ink Jet (TIJ), Thermal Transfer Overprinting (TTO) and Print and Apply Labelling Machinery (PALM). TTO is the preferred choice for coding onto flexible, web-based packaging materials. These materials and packaging applications include flexible laminated films to create pouches, sachets and bags, or to lid rigid trays and apply labels to the surface of other primary packs or code directly onto specialty flexible materials, such as medical paper or Tyvek.
TTO systems have the capability to print high resolution (300 dpi) human and machine readable codes to satisfy the UDI requirement and can also print graphics, logos and other variable text fields on large areas that can be used to decorate and customise the pack according to the unique content. This additional advantage of printing details and graphics of the pack contents (also in multiple languages) gives the medical device manufacturer the future option of saving operating costs. This is done by decreasing the number of packaging material stock keeping units (SKUs) and reducing the downtime incurred by changing the packaging SKU during changeovers.
Specialised for printing high resolution codes at high speed, TIJ proves to be an ideal solution for all cartons and certain foils. These systems use solvent- and water-based ink to print complex and durable codes at a fast repeat rate, while still delivering the required legibility that manufacturers have come to expect for UDI codes. The ability to easily integrate a TIJ print head into multilane applications also makes this system suitable for wider web coding applications. Employing multiple print heads to deliver individual codes across the substrate’s surface from a single controller gives significant cost and productivity benefits.
When larger label information needs to be printed and applied onto cases, or a label is the only option because of the substrate or the shape of a product, PALM proves to be an effective alternative to TIJ and TTO.
PALM can also be deployed for secondary and tertiary packaging applications. It distinguishes itself by being able to provide full GS1 codes (used to encode information such as product numbers, serial numbers and batch numbers) and multiple applicator options, including the corner wrapping of cases.
How EU regulation will affect coding and marking
With the deadline now set in place to comply with the mandatory requirements of the EU regulations relating to medical devices, manufacturers have been given a timeframe to ensure that they have all the affected areas of their business covered, including product identification.
As outlined throughout this report, there are multiple aspects to take into consideration to select the coding and marking system that is best suited for one’s business, such as substrates and materials, production volume, data management, etc. More importantly, manufacturers need to manage their timeframes as effectively as possible and act now. Sufficient time needs to be allowed to test solutions and potentially make the necessary adjustments to manage the new coding requirements. By taking action ahead of the deadline and partnering with a reliable supplier and partner that can provide the guidance and industry knowledge required, compliance can be successfully achieved.