CE Roadmap for Medical Devices Under the MDR / IVDR

During the design and development of a medical device, the question arises as to which regulatory requirements must be met. If the new medical device is to be marketed in Europe, CE marking is required—the requirements of the European Medical Device Regulation (MDR) or the European In Vitro Diagnostic Medical Devices Regulation (IVDR) apply.

At this point, we are repeatedly confronted with three questions:

What requirements must a product meet?
What are the costs involved?
How long does the entire process take?

In most cases, a “quick answer” to these important questions is not possible. This is because the product-specific requirements vary too greatly from one medical device to another. Added to this are the differences between companies and their respective processes, experience, and competencies.

For this reason, we have developed the “CE Roadmap.” The CE Roadmap is a structured analysis and planning process that transparently outlines the regulatory path to CE marking for a medical device. The CE Roadmap enables a precise assessment of the regulatory requirements for a specific product. This requirements profile is supplemented by a corresponding plan for the resulting costs and potential processing times. In addition, the CE Roadmap provides practical recommendations on the approach to take, market access for a medical device, processing times, and collaboration with Notified Bodies.

In this technical article, we present the CE Roadmapping process and its benefits for manufacturers of medical devices.

The structure of the CE roadmap

The CE Roadmap is divided into 10 key steps that are based on the requirements of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), and describe a product’s potential path to the European market:

1. Use case: What is the specific use case?
2. Intended purpose: What exactly is the product intended to do?
3. Qualification: Does the product qualify as a medical device under the MDR or as an in vitro diagnostic medical device under the IVDR?
4. Legal Basis: Which regulations are relevant?
5. Risk class: What is the medical device’s risk class?
6. Stakeholders: Who is responsible for which tasks?
7. Manufacturer obligations: What specific requirements must be met?
8. Conformity assessment: How is conformity demonstrated?
9. Post-market surveillance: How is the product monitored on the market?
10. Market access: What specific considerations must be considered when placing the product on the market?

What do these 10 steps entail in detail?

Use case

Technological developments can have a platform-like nature, making various medical use cases conceivable. If necessary, we discuss which use case appears most promising and should be pursued for the CE roadmap. In some cases, there may be multiple use cases with different requirements. We analyze a use case by mapping the problem, solution, and benefits, and focus on the respective medical users or target groups.

Intended purpose

The intended purpose specifies the purposes for which a product may be used and, if applicable, those for which it may not. It serves as the foundation for all subsequent steps and is therefore of essential importance. We analyze the intended purpose for suitability and Conformity. Upon request, we assist with drafting the wording.

Qualification

By comparing the intended purpose with the definition of medical devices, we determine whether the product qualifies as a medical device. Often, alternative use cases can be identified. This may lead to different approaches, meaning the product could be classified into a different risk class or brought to market as a non-medical device. This typically reduces the effort required by a factor of many.

Legal framework

In addition to the requirements of the MDR and IVDR, other requirements may apply on a case-by-case basis from a variety of other laws, legal acts, regulations, standards, guidelines, or recommendations. The CE Roadmap includes an analysis of these additional product-specific requirements.

Risk class

The MDR and the IVDR provide for different classification systems. Medical devices are classified into Classes I, IIa, IIb, and III, while in vitro diagnostic medical devices are classified into Classes A, B, C, and D. The higher the class, the more stringent the requirements that must be met. We review the mandatory risk classification based on the classification rules and implementing regulations and, if necessary, assist in justifying their application.

Stakeholders

The regulations define economic operators, each of whom has different rights and obligations. The specific combination of operators involved in developing and making a product available on the market plays a decisive role in determining the marketing costs incurred. These costs must be recouped through market sales. We therefore discuss the configuration of operators as part of a viable business model.

Manufacturer obligations

The Manufacturer, as defined by the regulations, bears full responsibility for a given product and places it on the market with all associated rights and obligations. To this end, the Manufacturer demonstrates that its product meets a series of requirements by:

conducting a clinical evaluation (MDR) or performance evaluation (IVDR),
establishing a risk management system,
meeting the general safety and performance requirements,
establishing a quality management system,
preparing instructions for use and label,
prepares technical documentation,
completes a series of registrations,
establishes specific functions, and
ensures adequate liability coverage.

The practical implementation of these tasks depends on the product characteristics, the project status, and the specific circumstances of a company. We conduct a gap analysis and discuss in detail which gaps need to be addressed and how, which documents apply, and which testing tasks are required.

Conformity assessment

The manufacturer declares the product’s conformity after applying a conformity assessment procedure. The MDR and IVDR describe several possible procedures in this regard. The selection depends on the type of medical device and its risk class. For products above risk class I under the MDR or above risk class A under the IVDR, a Notified Body is involved. We provide support in selecting an appropriate conformity assessment procedure, analyzing the resulting requirements, and collaborating with a Notified Body.

Post-market surveillance

The manufacturer establishes a process to monitor its medical device on the market, collaborate with the competent authorities and the Notified Body, and, if necessary, report serious incidents (Post-Market Surveillance and Vigilance, PMSV). Depending on the product type, this includes post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) activities. The analysis of these costs is also part of the CE roadmap.

Market access

The manufacturer affixes the CE mark and is authorized to place the product on the EU market. This often raises specific questions arising from the nature of the product, the reimbursement pathway, the market segments, or the business model. In many cases, these issues can be meaningfully addressed during the conformity assessment of a medical device. Typical examples include demonstrating medical benefit as part of the clinical evaluation regarding reimbursement, or the data protection and cybersecurity requirements for digital health applications (DiGA). For in vitro diagnostic medical devices, additional issues related to companion diagnostics, genetic testing, laboratory processes, or Performance studies may also be relevant. We discuss these synergies and incorporate them into the CE roadmap.

The CE roadmapping process

To develop the CE roadmap, we follow a standardized 5-step process:

Project Status: CE roadmapping begins with a joint (online) workshop to discuss the nature of the project and its status in detail. The objective is to develop a shared understanding of the project. We also determine what additional information we need to develop the CE Roadmap.
Gap Analysis: Here, we compare the status with the target status regarding MDR compliance requirements and the necessary documentation. This requires a draft statement for the intended purpose, support with the qualification as a medical device, and justification of a risk class.
Roadmapping: This is followed by the development of a roadmap that describes the exact path to a product’s CE mark.
Report: The CE roadmap is created and documented through an iterative procedure.
Implementation: In a subsequent (online) workshop, we discuss the key implementation steps, including risk assessment and recommendations for the next steps.

The benefits of the CE roadmap for medical device manufacturers

Medical device manufacturers must take on significant risks to bring innovations to market. Regulatory requirements and bureaucracy hinder market access. The MDR and IVDR have made the situation considerably more difficult. It is not without reason that a comprehensive reform of the MDR and IVDR is currently under discussion.

These regulations have greatly increased the effort required to obtain CE marking for medical devices. This makes it even more important to plan in detail what efforts and methodological issues a manufacturer will face. Many problems can be avoided early on if regulatory requirements are considered from the very beginning and missteps are prevented. Here, the CE Roadmap provides essential information and helps to properly review the economic risks of the project.

Smaller, young, or industry-new technology companies also face challenges when it comes to marketing medical devices. These projects are often financed by external investors. Here, the CE Roadmap helps ensure accurate assumptions are made when presenting the financing plan and builds trust with investors. The effort required to place a product on the market is often significantly underestimated.

Conclusion

The CE Roadmap is a practical approach to planning the CE marking for a medical device at an early stage. This allows for a better assessment of a project’s risks and feasibility and helps avoid costly missteps. We’d be happy to assist you in the implementation of your project.

CE Roadmap for Medical Devices: MDR/IVDR Requirements, CE Marking, Costs, and Time Required

Do you have any questions about your project or product?