EU MDR LABELING COMPLIANCE: LEARNING THE LESSONS FROM UDIA whitepaper from PRISYM ID and Be4ward

ABSTRACTThe European medical device industry is in the grip of the biggest changes the market has seen in decades.

Significant new rules to ensure the safety of medical devices became active in June 2017, imposing major new requirements on anybody involved in the design, manufacture, approval and commercialization of devices that are sold in the EU.

The EU Medical Device Regulation (MDR 2017/745 & MDR 2017/746), which replaces the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC), shifts regulation from a historical focus on the pre-approval

phase – the journey to CE Marking – to a comprehensive scrutiny of the entire product life-cycle.

This extended scope is forcing medical devices companies – and their external partners – to review and, where necessary, redesign processes and systems that touch every aspect of their operations.

The regulation will have particularly significant ramifications for labeling operations, where new requirements around product registration, in addition to a range of new labeling content requirements, is placing a renewed emphasis on companies’ ability to capture, manage and share data across the enterprise.

Although full implementation of EU MDR is not mandated until 2020, the transitional period has already begun. Crucially, the first major milestone in the adoption timetable – go-live for the new EU MDR European Database for Medical Devices (EUDAMED) – is scheduled for December 2018.

This alone will have a critical impact on companies’ ability to market new or existing products, yielding a range of associated labelling challenges that could prevent organizations from being able to sell their products if they are not addressed. With the clock ticking, it’s time to start planning for the EU MDR right now.

The need to adapt to changes in labeling requirements is not new. For example, the FDA’s phased introduction of Unique Device Identification (UDI) regulations is already challenging organizations that distribute medical devices in the US.

Similar legislation is currently being developed in other countries and regions and is likely to be enforced in the next few years.

For many companies, the process of adapting systems to comply with FDA UDI regulation has been long and turbulent. And so, as organizations face up to the challenges of EU MDR – which is broader and more complex than UDI regulation – there is much that companies can learn from that UDI experience.

This paper sets out those learnings, primarily through the lens of the labeling function, but with an appreciation of the wider context of the full regulations.

Following a recent survey conducted by PRISYM ID…

SELECT A LABELING SOLUTION THAT CAN ADAPT TO A CHANGING WORLDChanging regulations, such as evolving UDI, EU MDR or the EU clinical trial regulations, need to be incorporated into the label and artwork processes appropriately, and in time for when the regulation takes effect. And our solution may be the right one for you.

EliminatesHuman Error

Saves Time

ReducesWaste

Meets FDA & EU

Compliance

SafeguardsReputation

Saves Costs

Do companies have sufficient internal resources to implement the EU MDR?

of respondents think they need some or significant additional resources or they are not sure60%

What areas are likely to be affected?

EU MDR is not just the Responsibility of one DepartmentHave the correct people working on the implementation. Understand how you currently work. See the potential in changes. Have a business point of view. Do not expect that you will already have all of the skills you will need.

Labeling/Packaging

Quality

Operations

Logistics

Regulatory

Other

Top Concerns

Labeling/Packaging Regulatory Operations Project Manager

Timelines & reclassifications;Differences with UDI;

Post Market Surveillance

Unclear requirements;Time & resources;

Higher packaging costs;EUDAMED management

Implant cards process;Late implementation

Authorized representative;Resources; Timelines

respondents admittedthat they just started to think

about it

respondents admitted thatthey haven't started yet

respondents said theyunderstood the implications

and plans are in progress

26% 24% 50%

EU MDR (MEDICAL DEVICE REGULATION) IS THE INDUSTRY PLANNING FOR IT? ARE YOU?Whether you’re producing medical devices within Europe or supplying to Europefrom the rest of the world, as a manufacturer or supplier, you will need toadhere to the EU MDR by May 2020.

Following a recent survey conducted by PRISYM ID...

Speak to our Team of ExpertsUK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100

prisymid.com | info@prisymid.com

TIMELINE

EU MDR LABELING COMPLIANCE • Page 2 of 12 EU MDR LABELING COMPLIANCE • Page 3 of 12

EU MDR IN BRIEFThe full scope of EU MDR – as well as parallel new EU regulation for In Vitro diagnostics (IVDR 2017/746) – is wide-ranging, governing all aspects of the product life-cycle; from development, registration and manufacture, through to distribution, use/re-use, surveillance, recall and discontinuation.

The regulations compel companies to conduct a full-scale review of all their capabilities – QMS, processes, data management, IT systems and human resources – and is likely to dictate the need for new or modified competencies.

MACRO IMPLICATIONSAt the macro level, three major changes stand out. Primarily, the scope and classification of medical devices is being revised. Whilst the categories of classifications will remain the same, the definitions are being tightened. This means that some products may move into higher categories. Similarly, some products that have not previously been classified as medical devices are likely to be considered so in the future. These changes will impose new regulatory requirements on many products.

Secondly, new requirements around technical files, clinical evidence, vigilance and post-market surveillance will be hugely impactful. In particular, the regulations mandate demonstrable enhancements to clinical evidence and testing protocols. These will not only impact the registration of new products, they are also likely to affect the re-registration of existing products

and could require companies to conduct more trials to provide further retrospective information.

Finally, the legislation introduces the prospect of unannounced audits, to be conducted by notified bodies. EU MDR outlines the scope and frequency of these audits.

This is new territory for medical device manufacturers – and also for regulators – but it is a clear indication that EU MDR will be rigidly enforced. This should come as no surprise. The legislation was developed as a response to high-profile safety scandals that damaged the reputation of the industry.

These scandals, along with the emergence of new innovations such as nanotechnology, exposed weaknesses in the EU’s established regulatory framework for medical devices that EU MDR sets out to resolve. Manufacturers are likely to face increasing scrutiny. Compliance is not an option, it’s an obligation.

LABELING IMPLICATIONSThe top-line challenges cascade into a series of implications for labeling.

Following a recent survey conducted by PRISYM ID…

However, the most fundamental concerns should be product registration and – perhaps more critically – re-registration. EU MDR means that previous submissions that enabled companies to ship product to the EU effectively become invalid: manufacturers will need to re-register every medical device that’s supplied into the EU.

It seems unlikely that companies will be allowed to grandfather products though. Submissions will need to be made to the central EUDAMED database, which goes live next year. These new requirements will almost certainly dictate changes to labeling content – including the artwork and literature that is supplied with devices – all of which will need to be captured within the EUDAMED database.

In addition, chapter 3 of the legislation outlines very specific requirements around labeling content that companies must comply with if they wish to market in the EU.

These include, but are not limited to, a range of new requirements that deviate from UDI regulations:

• Single-use devices: labeling must specify how many times a device has been repackaged, sterilised and re-issued. It must also state how many times a device has currently been used

• Medical Device Symbol: all packages must carry a symbol – yet to be finalised – to show that it contains a medical device. This rule, in itself, means that all companies need to change their label designs to allow for the symbol’s inclusion

• Clinical investigation: a new statement needs to be printed on all labels. This information needs to be translated, depending on the country being shipped to

• Hazard warnings: all labels must clearly display a product’s residual risks

• Symbols: new mandatory symbols are to be introduced. However, these have not yet been harmonized across the EU

• Electronic labeling: all labeling information must be made available via the manufacturer’s website

• Electronic IFUs: the legislation paves the way for the end of paper-based IFUs. This is good news for medical devices companies – but reinforces the need for effective, integrated labeling systems

These are largely new, additional content requirements, or variations on existing ones. The diverse nature of the information required to fulfil them underlines the need for labeling infrastructure that reaches and connects every department and function within an organization.

The third aspect of EU MDR that will have significant labeling implications is the introduction of UDI requirements for all medical devices. Although many of these changes are in line with FDA UDI, one variation is in the scope of products covered by the EU serialization requirements around having to include serial numbers rather than just lot numbers. EU UDI will be applied to more devices than in the US, implying slightly tighter controls.

The purpose and specifics of UDI are not within the remit of this paper. However, a detailed outline is available within PRISYM ID’s White Paper: How GUDID was it for you?

SELECT A LABELING SOLUTION THAT CAN ADAPT TO A CHANGING WORLDChanging regulations, such as evolving UDI, EU MDR or the EU clinical trial regulations, need to be incorporated into the label and artwork processes appropriately, and in time for when the regulation takes effect. And our solution may be the right one for you.

EliminatesHuman Error

Saves Time

ReducesWaste

Meets FDA & EU

Compliance

SafeguardsReputation

Saves Costs

Do companies have sufficient internal resources to implement the EU MDR?

of respondents think they need some or significant additional resources or they are not sure60%

What areas are likely to be affected?

EU MDR is not just the Responsibility of one DepartmentHave the correct people working on the implementation. Understand how you currently work. See the potential in changes. Have a business point of view. Do not expect that you will already have all of the skills you will need.

Labeling/Packaging

Quality

Operations

Logistics

Regulatory

Other

Top Concerns

Labeling/Packaging Regulatory Operations Project Manager

Timelines & reclassifications;Differences with UDI;

Post Market Surveillance

Unclear requirements;Time & resources;

Higher packaging costs;EUDAMED management

Implant cards process;Late implementation

Authorized representative;Resources; Timelines

respondents admittedthat they just started to think

about it

respondents admitted thatthey haven't started yet

respondents said theyunderstood the implications

and plans are in progress

26% 24% 50%

EU MDR (MEDICAL DEVICE REGULATION) IS THE INDUSTRY PLANNING FOR IT? ARE YOU?Whether you’re producing medical devices within Europe or supplying to Europefrom the rest of the world, as a manufacturer or supplier, you will need toadhere to the EU MDR by May 2020.

Following a recent survey conducted by PRISYM ID...

Speak to our Team of ExpertsUK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100

prisymid.com | info@prisymid.com

EU MDR LABELING COMPLIANCE • Page 4 of 12 EU MDR LABELING COMPLIANCE • Page 5 of 12

LESSONS FROM THE UDI EXPERIENCEThe introduction of UDI requirements into the EU is good news for organizations that are already along the pathway of adopting systems and processes to support FDA UDI compliance.

However, for those that aren’t – and indeed those that

may have made only basic adjustments to their labeling infrastructure in response to the regulations – there are five key learnings that have emerged from the UDI experience that may help inform best practice adoption with EU MDR.

The size and scale of implementing UDI is commonly underestimated. Our experiences of working with both large and small organizations, along with analysis of progress elsewhere within the industry, indicate that companies can easily miscalculate the impact UDI implementation will have on their operations and the

cross-organizational involvement such projects require.

As a result, strategy development can become slow, complex and costly, with delivery timelines inevitably slipping.

Following a recent survey conducted by PRISYM ID…

Looking at the results we see that 50% of responses have already made a good start. They understand the impact and are planning or have already plans and budget in place. If you are not in that 50%, then now is the time to get started.

The most successful organizations established integrated UDI teams right from the outset. These not only included stakeholders from all relevant departments, they also engaged – and involved – external partners from an early stage to help shape strategy.

Conversely, companies that were late to approach UDI adoption often struggled to get the right partners on board due to them already being committed on other customer projects. UDI implementation requires significant effort in terms of data entry/approval, regulatory submissions, artwork design and approval. It makes sense to collaborate early.

The implications for EU MDR implementation are stark The new EU regulations are far more complex than UDI – with the latter being just one component of significant legislation. Moreover, the timelines on EU MDR adoption are challenging. With the EUDAMED database going live in December 2018, it’s hugely important to ensure operations are fit-for-purpose in good time. The regulators have stated that submissions will be processed on a first-come-first-served basis. Failure to submit early could risk delays in a company’s ability to ship product whilst they await a license. The ramifications are huge.

The best advice is to act now. Organizations need to be thorough in their planning to ensure resources – both internal and external – are properly aligned with business needs. That process should begin with a comprehensive review of existing capabilities to identify gaps and design solutions that address them.

One common misconception is that UDI implementation is a department-specific project for labeling and/or regulatory teams. This view signifies an under-appreciation of how labeling – and, more specifically, the data that is required to underpin it – is intrinsically linked to all aspects of a business. In some cases, companies identified UDI as a label design and

regulatory issue and developed separate projects to address these areas in isolation. The most successful organizations took a more collaborative approach, regarding UDI as a cross-functional responsibility and building multi-disciplinary teams to ensure solutions are based on the holistic needs of the company. In these cases, UDI implementation was much more effective.

The lessons for EU MDR implementation are clear. The EU legislation is much broader than UDI and has implications right across the product life-cycle. Companies therefore need to ensure that the development of systems to support compliance is based on the views of all relevant stakeholders – not simply regulatory departments or single-discipline functions.

As organizations embark on EU MDR implementation, it’s important to consider which departments need to be involved in formulating the solution – and engage them throughout the journey. Failure to do so can lead to avoidable delays or, in the worst extremes, systems that are not fit for purpose. The inherent costs can be significant.

A key learning when approaching any new implementation is the need to test existing systems. Whilst it’s often the case that an existing solution may be incapable of meeting your new requirements, there are also examples where legacy systems do possess the required functionality but nobody is aware of it. In the case of FDA UDI implementation, a recurrent problem for many companies was the need to include different GTIN on each level of packaging. In many organizations, their device data was designed for a single identifier and provided no means of storing additional GTINs.

Similar, some required companies to store the additional data across different, disparate systems.

The importance of having a ‘single source of the truth’ is widely acknowledged across the industry. However, even in systems that make the claim, access to the single source is sometimes denied because the interfaces to retrieve the data are poorly integrated.

The answer? Conduct ‘Fit for Purpose’ tests on both your software and your hardware – and if you’re unsure about capabilities and functionality, speak to your technology partners.

The UDI requirements of EU MDR may ultimately present challenges that cannot be simply resolved via your existing system.

SELECT A LABELING SOLUTION THAT CAN ADAPT TO A CHANGING WORLDChanging regulations, such as evolving UDI, EU MDR or the EU clinical trial regulations, need to be incorporated into the label and artwork processes appropriately, and in time for when the regulation takes effect. And our solution may be the right one for you.

EliminatesHuman Error

Saves Time

ReducesWaste

Meets FDA & EU

Compliance

SafeguardsReputation

Saves Costs

Do companies have sufficient internal resources to implement the EU MDR?

of respondents think they need some or significant additional resources or they are not sure60%

What areas are likely to be affected?

EU MDR is not just the Responsibility of one DepartmentHave the correct people working on the implementation. Understand how you currently work. See the potential in changes. Have a business point of view. Do not expect that you will already have all of the skills you will need.

Labeling/Packaging

Quality

Operations

Logistics

Regulatory

Other

Top Concerns

Labeling/Packaging Regulatory Operations Project Manager

Timelines & reclassifications;Differences with UDI;

Post Market Surveillance

Unclear requirements;Time & resources;

Higher packaging costs;EUDAMED management

Implant cards process;Late implementation

Authorized representative;Resources; Timelines

respondents admittedthat they just started to think

about it

respondents admitted thatthey haven't started yet

respondents said theyunderstood the implications

and plans are in progress

26% 24% 50%

EU MDR (MEDICAL DEVICE REGULATION) IS THE INDUSTRY PLANNING FOR IT? ARE YOU?Whether you’re producing medical devices within Europe or supplying to Europefrom the rest of the world, as a manufacturer or supplier, you will need toadhere to the EU MDR by May 2020.

Following a recent survey conducted by PRISYM ID...

Speak to our Team of ExpertsUK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100

prisymid.com | info@prisymid.com

Don’t Wait. Act Now

It’s not Just about Labeling

Test your Systems

Do you believe your company will be able to implement EU MDR before the provisional 2020 completion date?

0%

Yes, highly confident Probable Unlikely Not sure

10% 20% 30%

44% 39% 14%3%

40% 50% 60% 70% 80% 90% 100%

EU MDR LABELING COMPLIANCE • Page 6 of 12 EU MDR LABELING COMPLIANCE • Page 7 of 12

Following a recent survey conducted by PRISYM ID…

Looking at the subject of serialisation we can see from the survey that already a 5th of the responses recognise that they will need to implement serialization with nearly 2/3rds not yet sure.

The stricter serialization requirements is just one example where organizations may require new skills, systems, procedures and hardware. The latter can often be overlooked. However, UDI imposes new standards on

the quality of barcoding – and deficiencies can come down to a hardware issue, namely the quality of your printer.

To avoid these, and other potential issues, it’s vital that companies proactively review and test their systems to identify any limitations early. The long-term consequences of an ineffective system can be considerable.

The importance of data to the modern enterprise cannot be overstated. A company’s ability to manage, integrate and optimize its data assets is fundamental to its success. This is particularly the case in medical devices labeling, where data is the lifeblood of any system. As regulations compel organizations to include data sourced from every part of an enterprise on their labeling and packaging, the need for robust, accurate

and trusted data is only going to increase. However, despite organizations being sold the promise of a ‘single source of the truth’, our UDI implementation experience highlighted a number of companies that, prior to that point, had low levels of trust in the ‘single source’ concept. Many did not have sufficient confidence in it for UDI implementation. Rebuilding that confidence can be extremely difficult.

Perhaps one of the most important lessons for EU MDR implementation is the need to understand – and trust – your data model. It is vital to know where your data is stored, how it’s maintained, who has ownership of it and what controls are in place to assure its integrity. Storing data in the wrong system or having it

maintained by the wrong people will significantly impact a model’s sustainability. The most effective solutions allow users to capture data that meets regulatory requirements but also enables it to be maintained in a way that meets the requirements of everyone that consumes it.

The final lesson is the need for operational agility. This means thinking longer-term and building solutions that flex as the regulatory environment evolves, rather than developing systems that focus solely on narrow, specific requirements. EU MDR implementation requirements, rather like FDA UDI, are not only substantial and complex, they carry challenging

timeframes. However, our experiences in the US show that the companies who failed to take the opportunity to look beyond UDI requirements and build in capacity to flex their system, will likely have a suboptimal system as the landscape shifts. Some companies chose to take shortcuts in order to meet immediate deadlines, in the process compromising the long-term solution.

The key learning is to think ‘bigger picture’ and assume that the market will inevitably change. Some of those changes are predictable; the introduction of EU MDR has been five years in the making, whilst imminent UDI regulations in other countries around the world are widely known. It’s therefore important to develop an EU MDR solution that is not only designed to tackle

the regulatory challenges of today, but can also provide a platform to address the evolving needs of tomorrow. A good technology partner will know how to design systems that are based on a deep understanding of the industry and the regulations with which companies are required to comply.

Ensure your Data is Reliable

Be Ready for continued Change

Is this legislation going to cause you to implement unique serialised identification to product level?

Yes, up to 20%

Not sure

Yes, morethan 20%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

EU MDR LABELING COMPLIANCE • Page 8 of 12 EU MDR LABELING COMPLIANCE • Page 9 of 12

PRISYM ID World Class Label Management Software

PRISYM ID designs and delivers label management software for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, removing risk and significantly reduce costs by eliminating recalls through labeling errors.

PRISYM ID is the market leader in providing validatable world-class label lifecycle management, and is trusted for delivering personalized service excellence to clients.

For further information, please go to:

+44 (0) 1189364400 | +1 508-948-6100 www.prisymid.com | info@prisymid.com | @prisymid

THE SOLUTIONThe most effective modern labeling solutions will adopt a data-led approach. Moreover, underpinned by the correct data structure and management processes, they’ll power all the downstream benefits of integration, connectivity, visibility and control.

PRISYM ID’s proprietary label life-cycle management solution, PRISYM 360, gives medical device organizations a 360° view of their master data assets. By focusing on the data and ensuring it is available to the right people at the right time, the core components

of label lifecycle management – label design, workflow processes, inspection capabilities and audit control – all flow naturally.

Furthermore, at a time of increased scrutiny and enduring regulatory change, the solution gives organizations complete label integrity to meet the compliance requirements of FDA and EU regulations – as well as the scope to adapt to emerging regulations as and when they occur.

EU MDR is transforming the nature of medical devices business in the EU. The challenge is to embrace the lessons of FDA UDI implementation; don’t wait – collaborate, evaluate, validate and innovate.

The world is changing. The question is: does your labeling solution allow you to change with it? The time to act is now.

EliminatesHuman Error

Saves Time

ReducesWaste

Meets FDA & EU

Compliance

SafeguardsReputation

Saves Costs

SELECT A LABELING SOLUTION THAT CAN ADAPT TO A CHANGING WORLDChanging regulations, such as evolving UDI, EU MDR or the EU clinical trial regulations, need to be incorporated into the label and artwork processes appropriately, and in time for when the regulation takes effect. And our solution may be the right one for you.

Don't Wait. Act Now

Late UDI adopters struggled to get suppliers onboard as they were already committed on otherprojects.

A UDI team was not built from thebeginning which led to late involvement

of relevant departments.

UDI Tasks required significant effort for dataentry/approval; regulatory submissions, artworkdesign and approval.

The EU MDR has more complexity than UDI.Ensure that you start as early as possible and plan

your resources both internally and externally.

1

It's not Just about Labeling

UDI was seen as department specific project forLabeling or Regulatory teams.

Where companies viewed UDI as a crossdepartmental problem, successful

implementation was more efficient.

As you embark on your EU MDRimplementation consider what departments

need to be involved in the solution.

2

Test your Systems

Problems were caused by requiring differentGTIN for each packaging level.

Required UDI functionality was available in theexisting systems but nobody was aware.

Systems that contained the ‘Single Source ofTruth’ for data had limited integration options.

For the EU MDR project review processes, systems andequipment. Do not compromise entire systems or

processes due to one legacy component.

3

Ensure your Data is Reliable

Single source of truth was not trusted for UDIimplementation. And the confidence was notrebuilt.

New UDI data was stored where it waseasiest to implement, rather than where it

was best maintained.

Ensure that the EU MDR solution not only allows you to get thedata in to meet the requirements but also that it can be

maintained in a way that meets the needs of all the data users.

4

Be Ready for continued Change

The UDI opportunity was not used to improvecurrent practices.

Companies took shortcuts to meetimmediate UDI deadlines, compromising

the long term solution.

Companies didn't expect any further regulatorychanges.

Ensure you implement an EU MDR solution that isdesigned to help you deal with changes which have a

broad impact.

5

UDILESSONSLEARNT

Embrace them for theEU MDR Implementation

Speak to our Team of ExpertsUK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100

prisymid.com | info@prisymid.com

EU MDR LABELING COMPLIANCE • Page 10 of 12 EU MDR LABELING COMPLIANCE • Page 11 of 12

Speak to our Team of ExpertsUK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100

www.prisymid.com | info@prisymid.com