Own Brand Labelling for Medical Devices | Optimise Compliance & Branding | QREG

Welcome to our latest blog post where we will be looking into Own Brand Labelling (OBL) in the medical device sector. 

This strategy, where companies market and sell medical products manufactured by others under their own brand name, offers a blend of branding prowess and strategic agility. 

Own Brand Labelling not only simplifies the route to market entry but also ensures companies can focus on what they do best, innovate and enhance their brand value while maintaining strict compliance with regulatory standards like CE marking and the Medical Device Regulation (MDR).

We will explore: 

• How Own Brand Labelling works, 
• The regulatory requirements involved, and 
• The benefits and challenges that come with adopting this approach. 

Whether you’re a startup eyeing rapid market expansion or an established brand looking to diversify your product offerings, understanding Own Brand Labelling is crucial in navigating the complexities of the medical devices industry. 

Join us as we unpack the essentials of this strategy, providing you with the knowledge to leverage Own Brand Labelling effectively in your business endeavours.

Understanding Own Brand Labelling

The definition of own label brand involves a company adopting a product manufactured by another entity, the OEM, and selling it under its own branding. 

This strategy is particularly prevalent in the medical device industry, where compliance with regulatory standards such as CE marking is critical. The own brand label encompasses all responsibilities from product safety and efficacy to regulatory obligations.

This approach offers significant advantages, including reduced costs and accelerated time to market, but it also requires a deep understanding of regulatory responsibilities and compliance.

What is Own Brand Labelling?

Own Brand Labelling refers to the process where a company, known as the “brand owner” or “own brand labeller,” places its brand on a product made by an original equipment manufacturer (OEM). 

The brand owner then takes on the responsibility for the marketed product, including compliance with regulatory requirements, maintaining product certifications like CE marking, and handling customer complaints.

Regulatory Aspects of Own Brand Labelling in the Medical Device Industry

Own Brand Labelling (OBL) presents a unique set of regulatory challenges and responsibilities in the medical device industry. When a company chooses to market a product manufactured by another entity under its own brand name, it assumes all the regulatory burdens associated with that product. 

Understanding the regulatory framework that governs Own Brand Labelling is crucial for:

• Compliance, 
• Market access, and 
• Maintaining the integrity of the brand.

Compliance with Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) in the European Union has set forth stringent guidelines that own brand labellers must adhere to. 

These regulations are designed to ensure that all medical devices sold under the EU jurisdiction meet the same standards of quality, safety, and efficacy. For own brand labellers, this means:

Technical Documentation: 

Own brand labellers must have access to complete technical documentation of the product they are branding. This includes design and manufacturing details, evidence of safety and performance, and the results of clinical evaluations.

Declaration of Conformity: 

Companies engaged in OBL must be able to provide a Declaration of Conformity. This document asserts that the medical device complies with all applicable EU regulations.

CE Marking: 

The CE mark, visible on medical devices, indicates that the product meets the EU standards for health, safety, and environmental protection. 

Own brand labellers are responsible for ensuring that the CE marking process is accurately carried out and maintained, reflecting compliance with all necessary directives and regulations.

Quality Management Systems (QMS)

Adhering to a robust Quality Management System (QMS) is another critical aspect of regulatory compliance for own brand labellers. Under the ISO 13485 standard, which specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices, own brand labellers must ensure:

Supplier Oversight: 

Effective management of the OEM to ensure that the product continuously meets the required standards.

Product Traceability and Recall Management: 

Systems must be in place for tracing products throughout the supply chain and effectively managing recalls if necessary.

Post-Market Surveillance

Post-market surveillance is a continuous process required under MDR. Own brand labellers must monitor the performance and safety of their products after they have been released onto the market. 

This involves:

• Gathering data on product performance in real-world scenarios.
• Reporting incidents where products may have caused or contributed to serious deterioration in health or death.
• Implementing corrective actions when necessary to ensure ongoing compliance and safety.

Contractual Agreements

Establishing clear and comprehensive contractual agreements with OEMs is vital. These contracts should cover: 

• Aspects such as liability, 
• Regulatory responsibilities, 
• Quality assurance, and 
• Access to all necessary documentation. 

Ensuring that both parties understand and agree to their roles in compliance and quality management is essential for mitigating risks associated with Own Brand Labelling.

Examples and Strategic Implementation of Own Brand Labelling in the Medical Device Industry

Own Brand Labelling offers a strategic advantage to companies in the medical device sector by allowing them to expand their product portfolios and enter new markets more quickly. 

By understanding how other companies have successfully implemented OBL strategies, businesses can better navigate the complexities of this approach.

Real-World Examples of Own Brand Labelling

Example 1: Diagnostic Devices

A well-known company in the healthcare sector wanted to expand its range of diagnostic equipment but lacked the specific technology to manufacture advanced imaging devices. 

By adopting an OBL strategy, the company was able to partner with an OEM that specializes in high-end imaging technology. 

Under the OBL arrangement, the company branded and marketed these state-of-the-art devices as its own, significantly enhancing its product offerings and market reach without the extensive costs associated with R&D and manufacturing.

Example 2: Surgical Instruments

Another example involves a surgical instrument company that sought to broaden its surgical tools line. 

The company partnered with an OEM known for its innovative and reliable surgical instruments. 

Through OBL, the company was able to offer a more diverse range of products to hospitals and clinics, leveraging the OEM’s expertise in manufacturing while focusing its efforts on branding, marketing, and customer service.

Strategic Implementation of Own Brand Labelling

Step 1: Selection of a Reliable OEM

Choosing the right OEM is crucial. The brand owner must ensure that the OEM not only produces high-quality products that comply with all relevant regulations but also aligns with the brand owner’s values and quality standards.

Step 2: Regulatory Compliance and Documentation

The own brand labeller must maintain a thorough understanding of all regulatory requirements, including CE marking and compliance under the Medical Device Regulation (MDR). 

They must also ensure that all necessary documentation, such as the Declaration of Conformity and technical documentation, is in order and readily accessible.

Step 3: Quality Management and Control

Implementing a robust Quality Management System (QMS) is essential to oversee the entire process and ensure that products consistently meet the required standards. This system should cover everything from product design and manufacturing to post-market surveillance and adverse event reporting.

Step 4: Marketing and Branding

Effective marketing strategies are vital for the success of OBL products. The brand owner should focus on creating strong brand recognition and customer loyalty. 

This involves clear messaging that highlights the quality and reliability of the products, backed by the branding and resources of the own brand labeller.

Step 5: Continuous Monitoring and Improvement

Continuous evaluation and improvement are necessary to ensure ongoing compliance and success in the market. 

This includes: 

• staying updated with regulatory changes, 
• monitoring customer feedback, and 
• implementing improvements in response to market demands and technological advancements.

Own Brand Labelling in the Context of the Medical Device Regulation (MDR)

Own Brand Labelling in the medical device industry must align closely with the requirements of the Medical Device Regulation (MDR), which came into full effect in the European Union in May 2021. 

The MDR replaces the previous directives, notably the Medical Device Directive (MDD), and imposes stricter regulations to ensure higher levels of safety and performance in medical devices sold within the EU. 

For companies involved in OBL, understanding, and adapting to these changes is crucial for maintaining compliance and securing market access.

Key Aspects of the MDR Affecting Own Brand Labellers

1. Increased Traceability and Identification:

The MDR introduces more rigorous requirements for the traceability of medical devices. Each device must have a Unique Device Identification (UDI) to facilitate its tracking through the supply chain. 

For own brand labellers, this means ensuring that all devices they brand carry a UDI that is registered and traceable, enhancing post-market surveillance and recall capabilities.

2. Increased Obligations for Clinical Evidence:

Under the MDR, there is a heightened emphasis on the need for clinical evidence demonstrating the safety and efficacy of medical devices. Own brand labellers must have access to comprehensive clinical data from the OEM and possibly conduct additional studies to confirm that the device complies with the new regulation. 

This requirement ensures that all medical devices, regardless of branding, meet a uniform standard of clinical validity.

3. More Stringent Post-Market Surveillance:

The MDR requires a more systematic and proactive approach to post-market surveillance. Own brand labellers are responsible for continuously monitoring the performance and safety of their devices on the market. 

They must set up systems to collect and analyse real-world data, report adverse events, and implement corrective actions swiftly.

4. Updated Risk Management Requirements:

Risk management must be an ongoing process throughout the lifecycle of the medical device. 

Own brand labellers must ensure that their QMS (Quality Management Systems) include: 

• processes for regular risk assessment, 
• mitigation, and 
• management strategies that comply with the MDR’s requirements.

5. Responsibilities of Economic Operators:

The MDR defines specific roles and responsibilities for all economic operators, including manufacturers, distributors, and importers. 

Own brand labellers are considered the legal manufacturers of their devices and, therefore, must fulfill all regulatory obligations of manufacturers under the MDR. 

This includes ensuring the conformity of devices, maintaining declaration of conformity, and keeping technical documentation up to date.

Strategic Implications for Own Brand Labellers

Upon reaching the difficulties of the MDR requires strategic planning and a thorough understanding of the regulatory landscape. Own brand labellers must:

Enhance Collaboration with OEMs: 

Strong partnerships with OEMs are vital to ensure access to all necessary documentation and data. Contracts should clearly delineate responsibilities concerning MDR compliance.

Invest in Regulatory Expertise: 

Companies may need to expand their regulatory teams or invest in training to keep up with the demands of the MDR, ensuring that their staff is well-versed in the latest regulatory requirements.

Implement Robust Systems: 

Developing and maintaining robust systems for documentation management, risk management, and post-market surveillance is essential to comply with the MDR’s stringent requirements.

Branding and Market Expansion Through Own Brand Labelling

Own Brand Labelling (OBL) offers a unique opportunity for companies in the medical device industry to expand their brand presence and penetrate new markets without the extensive costs and risks associated with developing and manufacturing new products. 

This strategy not only facilitates rapid market entry but also enhances brand recognition and customer loyalty by associating the company’s name with a wider range of products.

Leveraging Brand Identity

A critical advantage of OBL is the ability to leverage the existing brand identity to market products that are manufactured by others. This approach can significantly strengthen a brand’s market position. 

By carefully selecting products that align with the company’s values and market image, a business can ensure consistency in quality and performance, reinforcing customer trust and brand integrity.

Market Expansion

OBL allows companies to diversify their product offerings more quickly and with fewer overhead costs. This is particularly advantageous for small to medium-sized enterprises (SMEs) that may not have extensive resources for research and development. 

By adopting products that are already developed and have established market acceptance, companies can bypass the lengthy and costly R&D phase and move directly to marketing and sales, thereby accelerating time to market.

Targeting New Segments

With OBL, companies can target new customer segments that may have been unreachable due to limitations in their existing product lines. 

For example, a company specialising in non-invasive medical equipment can begin offering invasive tools under their brand through OBL, thus addressing a new segment of the healthcare market. 

This strategy not only expands the company’s footprint but also enhances its competitive edge in the industry.

Strategic Brand Positioning

The success of OBL heavily relies on strategic brand positioning. Companies need to ensure that the products they choose to label as their own resonate with their brand’s message and meet the expectations of their customer base. 

This involves thorough market research to understand customer needs and preferences, competitive analysis to identify market gaps, and strategic marketing to effectively communicate the value proposition of the newly branded products.

Enhancing Brand Loyalty

Own brand labelling offers an excellent opportunity to enhance brand loyalty by consistently providing quality products that meet or exceed customer expectations. 

By ensuring that all OBL products adhere to the highest standards of safety and efficacy, and by maintaining excellent customer service, companies can strengthen customer trust and loyalty, which is crucial for long-term brand success.

In conclusion

Own Brand Labelling (OBL) represents a strategic opportunity for companies in the medical device industry to enhance their market presence, diversify product portfolios, and increase brand loyalty while adhering to stringent regulatory standards. 

By carefully managing the regulatory, operational, and branding challenges associated with OBL, companies can leverage existing innovations and technologies to expand their offerings and reach new customer segments effectively. 

Success in OBL requires a commitment to maintaining high standards of quality and compliance, robust partnerships with OEMs, and a keen understanding of market dynamics. 

As the medical device landscape continues to evolve, the ability to adapt and optimise OBL strategies will be crucial for companies aiming to thrive in this competitive environment.

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