MDR requirements for product families

Product families are groups of devices that share similar design, intended use, and risk classification. Under the MDR, establishing a product family can reduce the compliance burden by consolidating documentation and testing requirements. However, defining these requirements accurately is critical. You need to consider four things:

1. Intended purpose – All products in the family must be supported by one defined medical purpose which works for all family members (Article 2 of the MDR). 
2. Risk classification – Ensure all products in the family fall under the same risk class (see Annex VIII of the MDR).
3. Commonality of design and technology – Devices should share similar design features, materials, and manufacturing processes. 
4. Clinical and safety performance – Similar clinical evidence and risk profiles are critical for grouping devices as a family.

Collaborating with your Notified Body

Notified Bodies play a central role in the MDR certification process. Given the complexities of grouping devices, building a strong, collaborative relationship with your Notified Body is especially important for successful certification of product families. 

Early engagement during the planning phase helps align expectations and ensure smooth communication. Providing comprehensive technical documentation, including a well-defined rationale for grouping devices into a family, is crucial for establishing clarity. 

A clear explanation of how clinical evaluations apply to the family as a whole and a justification for extrapolating data from individual variants also ensures transparency. Addressing potential concerns proactively with proposed solutions further strengthens this collaboration and reduces delays in certification. 

Defining the intended purpose

Clearly defining the intended purpose or use of your devices is foundational to MDR compliance. ‘Intended purpose’ underpins the entire regulatory framework, influencing risk class, the clinical evaluation, labeling, and performance testing. For product families, it’s essential to ensure the intended use is broad enough to encompass all variants within the family while being specific enough to satisfy regulatory scrutiny. 

Developing and aligning intended use statements for the entire product family can help streamline this process and provide clarity across multiple product lines. The intended use should align with the family’s risk assessment and clinical evaluation documentation, and it’s important to avoid vague or overly broad definitions that could raise a red flag with your Notified Body. 

Assigning products with EMDN codes

European Medical Device Nomenclature (EMDN) codes are essential for identifying and categorizing devices under MDR. Accurate EMDN code assignment ensures smooth interaction with the EUDAMED database and compliance with post-market surveillance requirements. 

For product families, the process can be streamlined by grouping variants within the family and identifying a common EMDN code that covers the overarching category. Similarities in technology and intended use can help in selecting the most fitting code. It also opens the door for a sampled review of your product dossiers. 

To ensure compliance, it is a good idea to validate your chosen code with MDR specialists or Notified Body. Your own Notified Body cannot advise you – but you could reach out to  independent consultancy experts – for their feedback. This ensures the code accurately represents the product family and mitigates the risk of complications during regulatory submissions.

Managing Unique Device Identification (UDI)

The Unique Device Identification (UDI) system is a central component of the MDR, ensuring traceability and transparency. For product families, efficiently managing UDI requirements can save significant time and resources. 

Defining a Basic UDI-DI (Device Identifier) for the entire family or for a family branch can also be an effective strategy. Devices sharing common specifications, such as duration of use, dimensions or materials, can benefit from hierarchical UDI-DI relationships, simplifying their management. Grouping products under one Basic UDI-DI may also open the door for a sampled review by your Notified Body. They have the mandate to certify products by sampling rather than reviewing all product variants. 

Addressing product variants in documentation

The way you address variants within a product family is key for achieving MDR compliance without overextending resources. Variants may differ in terms of size, color, or specific technical configurations while retaining a common intended use and design basis. 

To manage variants effectively, it is important to document the differences clearly in a product family dossier, enabling regulators to understand how variants align with the family. Testing processes can be streamlined by conducting representative testing for key variants instead of duplicating efforts for every individual product. Defining “worst cases” can help you with that.

Optimizing sampling size for testing

Sampling is risk-based: higher-risk devices require larger sample sizes or more comprehensive testing. For product families, determining the appropriate sampling size for testing is a balancing act between ensuring robust evidence and avoiding excessive costs. 

Selecting representative samples that encompass the full range of design and performance characteristics within the family helps ensure reliable outcomes without unnecessary duplication. Engaging with your Notified Body at an early stage to validate the approach can prevent delays and avoid potential pitfalls.

Product testing and feedback loops

Testing and iterative feedback are critical to MDR compliance. For product families, adopting a strategic approach to testing helps you balance thoroughness with efficiency. Batch testing for common features like materials, biocompatibility, and sterility across the family minimizes redundancies while ensuring safety and performance. 

Another tip is to use the lead product within a family to establish performance benchmarks for others. Regularly updating testing protocols based on post-market surveillance data ensures ongoing compliance with evolving standards. Establishing robust feedback loops through post-market surveillance systems helps collect real-world data across the product family, enabling proactive risk management and continuous improvement. 

We can help optimize your product family

Transitioning to the MDR is challenging but manageable with a strategic approach to defining your product families. By aligning regulatory requirements, optimizing processes for UDI and EMDN coding, managing variants effectively, and leveraging Notified Body collaboration, you can reduce the regulatory burden while ensuring safety and performance. 

With careful planning, navigating the complexities of MDR compliance becomes a manageable, achievable goal for even the largest product portfolios. Bringing in external expertise can also be a game-changer. Here at Peercode, our regulatory specialists can help streamline your compliance efforts. By helping to ensure your regulatory readiness, we free up time and resources for you to focus on innovation and market growth. 

Discover how regulatory consultancy from Peercode can help you streamline compliance for your product family, speak to a specialist today. Book a meeting