May 17, 2020

Top trends in enterprise labeling: Part 1

Big Data
Big Data
6 min
By taking a standardized approach, companies can ensure that a common set of labels, centralized applications and data sources are used across the supply chain.
Today, there are a variety of factors impacting supply chain strategy and ultimately labeling processes. Therefore, its important to take a close look a...

Today, there are a variety of factors impacting supply chain strategy and ultimately labeling processes. Therefore, it’s important to take a close look at what changes are driving today’s trends in labeling, which has become a mission-critical component in the supply chain as businesses continue to expand globally.

Growing customer demands and evolving regulatory requirements are just a couple of the trends which have been identified based on input from over 500 supply chain professionals, from a wide range of leading global companies, in a recent Enterprise Labeling Trends Survey. 

1. Business are standardizing labeling for consistency and efficiency

As business continues to expand globally, com­panies are recognizing the benefits of standard­izing their labeling across global supply chains. Standardizing enables labeling consistency, and dramatically streamlines maintenance and oversight, while offering the control to make rapid label changes throughout the supply chain. This standardized approach also helps global companies ensure business continuity in the face of disaster and empowers them to meet complex, global and high volume labeling demands.

RELATED TOPIC: Where is the future of the health care supply chain headed?

There are three important drivers behind the push to standardize:

  • Providing simplified maintenance and deployment: Offering the ability to centralize and deploy a standard labeling solution provides a wide range of benefits. Rather than manage multiple dif­ferent systems, this standardized approach enables companies to streamline maintenance while support­ing enterprise-wide labeling changes. In addition to reducing cost and simplifying maintenance, having a single, scalable solution facilitates expansion to new global locations.
  • Ensuring labeling consistency: As businesses extend their reach across the global supply chain, it’s critical they maintain labeling consistency across mul­tiple markets and regions. By taking a standardized approach, companies can ensure that a common set of labels, centralized applications and data sources are used across the supply chain. Also, ensuring consis­tency helps support compliance with brand standards which can rely on labels to help businesses differenti­ate their products, build relationships and maintain customer’s trust regardless of where in the world labels are printed.
  • Supporting business continuity: Both natural and man-made disasters can have a significant impact on a company’s supply chain and ultimately result in substantial financial consequences. Just as companies might shift production from one facility to another, a standardized approach to labeling allows them to rapidly shift label production in the same manner. By standardizing on a central labeling solution, compa­nies can leverage the data and labels needed to keep the supply chain flowing and minimize the impact during a disruption.

2. Integrated, dynamic labeling is essential

Today’s labeling needs to be both dynamic and data-driven to meet evolving customer and regulatory standards. Customers’ labeling requirements are more demanding and variable than ever and businesses failing to meet those requirements in a timely fashion find themselves with dissatisfied customers that are likely to turn to competitors. However, certified integration to the sources of truth for label data allows compa­nies to automate labeling processes directly from enterprise applications while ensuring label data accuracy. This approach reduces the need to maintain countless permutations of labels, enabling configurable business logic to trigger labeling and empower companies to quickly re­spond to evolving regulatory, language, region­al, business and customer specific requirements.

RELATED TOPIC: How pharma supply chains need to change for the future

Customer responsiveness in labeling typically centers on meeting the following expectations:

  • Integration with business systems is imperative: Integration models which support the seamless exchange of data and eliminate the need for manual processes allow companies to maintain their existing systems and user interactions, while automat­ing their labeling processes and improving overall efficiency. Although on-demand printing of labels is still important for many businesses, integrating label­ing with enterprise applications and existing business processes is a best practice for labeling in today’s global supply chain.
  • Meeting customer and regulatory require­ments: More than ever customers are imposing labeling requirements including unique formats, barcodes, logos, languages, and data attributes. Also, new standards and regulations are dictating which requirements need to be applied to labels to meet compliance. Companies are seeking the capability to meet a wide range of variable labeling requirements without forcing an overwhelming amount of manual oversight. Without the ability to meet these customer requirements, businesses are faced with costly and time-consuming relabeling, increasing fines, customer dissatisfaction and loss of business.
  • Allowing rapid label changes: Today busi­nesses must be able to respond in a timely fashion to a wide range of customer and regulatory demands. Without the ability to streamline label changes, companies will be confronted with missed delivery dates, hefty fines and dissatisfied customers. Configu­rable business logic allows business users to quickly and easily support new requirements, enabling label formatting and content to be changed dynamically.

3. Labeling intersects the supply chain at all levels  

Labeling has become a significant consider­ation for supply chain activities that span from upstream production to downstream distribu­tion and delivery of finished goods. To ensure an effective supply chain strategy, companies must consider how labeling intersects all levels of their supply chain. This is especially true with evolving demands such as globalization of manufacturing, safety and quality of prod­ucts, shorter lead-times, lean business environ­ments, and changing market dynamics. By adopting this mindset businesses are able to become more responsive and efficient through­out their supply chain.

RELATED TOPIC: How NHS SBS is transforming health care procurement

There are three important considerations behind label­ing intersecting the supply chain:

  • Increasing supply chain collaboration: Supply chain collaboration aligns processes to stream­line business, allowing global companies to reduce costs and add value to partners throughout the supply chain. Collaboration allows suppliers and business partners to work together to define their requirements for labeling. This allows business partners to deliver compliant labels that are specifically designed to have the attributes, data content, formatting and symbologies needed to improve efficiency, expand productivity, increase com­petitive advantage and meet customer demands.
  • Extending labeling for business partners and suppliers: Collaboration allows businesses connected within the supply chain to work together and extend access to labeling solutions. To engage in true collaboration, businesses must provide centralized control, allowing partners access to essential label­ing capability, while ensuring that data needed for labeling is made securely accessible for label printing. This approach safeguards label accuracy and ensures adherence to corporate and brand standards.
  • Reducing occurrences of mislabeling and relabeling: Adhering to standards and business requirements so that all goods are properly labeled is imperative in successfully moving product throughout the supply chain. If not, mislabeling can mean a lack of compliance and result in loss of business, costly fines or returns due to downstream processing errors. At the same time, the need to re-label can cause operational efficiency delays and downstream processing costs. However, implementing a common approach to labeling can offer consistency and minimize the need for redun­dant labeling processes. 

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.

The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.

The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.

The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline. 

This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:

Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking. 

Rigorous Planning
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.

Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.

Authorised Representatives
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.

For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established. 

Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users. 

While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.

Clinical Investigations
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.

Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.

Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.

As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.

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