Every time a medical device is developed, the question comes up as to which regulatory requirements must be met. If the new medical device is to be marketed in Europe, it requires CE marking: the requirements of the European Medical Device Regulation (MDR) apply.
We are then usually asked 3 questions:
- What requirements must a product fulfill in detail?
- What does it cost to implement these requirements?
- How long does the approval take?
A "quick answer" to these important questions is not possible in most cases. The product-specific requirements differ too greatly from one medical device to the next. Added to this are the differences between companies and the processes, experience and competencies available there.
For this reason, we have developed the "CE Roadmap". The CE Roadmap provides a precise statement of the regulatory requirements for a given product. This requirement profile is supplemented by a corresponding cost planning for implementation and approval. In addition, the CE roadmap provides practical recommendations on the regulatory strategy, market access of a medical device, required times or cooperation with Notified Bodies.
In this article, we present the CE roadmapping process and the benefits for medical device manufacturers.
The structure of the CE roadmap
The CE roadmap is divided into 10 essential steps, which are based on the requirements of the European Medical Device Regulation (EU) 2017/745 (MDR) and describe the possible path of a product on the European market:
- Use case: What is the exact use case?
- Intended purpose: What exactly is the product supposed to do?
- Qualification: Is the product a medical device?
- Legal bases: Which are relevant?
- Risk class: What is the risk class of the medical device?
- Actors: Who assumes which task?
- Manufacturer's obligations: Which requirements have to be fulfilled in detail?
- Conformity assessment: How is conformity demonstrated?
- Post-market surveillance: How is the product tracked on the market?
- Market access: What special aspects must be considered when placing the product on the market?
What do these 10 steps involve in detail?
Use Case
Technology developments can have a platform character, so that different medical use cases are possible. If necessary, we discuss which use case seems most promising and should be pursued for the CE roadmap. If necessary, there are several use cases with different requirements. We perform the analysis of a use case based on a mapping of problem, solution and benefit and focus it on the respective medical user or target groups.
Intended use
The intended use specifies the purposes for which a product may and may not be used. It is the basis for all subsequent approval steps and is therefore essential. We analyze an intended use for suitability and conformity. On request, we provide support with a draft formulation.
Qualification
By comparing the intended use with the definition of medical devices in the MDR, we discuss whether or not the device is a medical device. Alternative use cases are often possible. This can result in other procedures, i.e. the product can be classified in a different risk class or be marketed as a non-medical device. This usually reduces the effort many times over.
Legal basis
In addition to the requirements of the MDR, further requirements from a variety of other laws, legal acts, regulations, standards, guidelines or recommendations are added on a case-by-case basis. The CE roadmap includes the analysis of these additional product-specific requirements.
Risk class
The MDR provides for risk classes for medical devices. The higher the class, the higher the requirements to be met. We look at the mandatory risk classification based on the classification rules and implementing regulations and, if necessary, help to justify their application.
Stakeholders
The MDR defines economic actors who have different rights and obligations. The set of players who bring a product on the market influences the marketing costs, which in turn must be refinanced on the market. We therefore discuss the set of players as part of the business model..
Manufacturer obligations
The legal manufacturer as defined by the MDR are fully responsible for a respective product and places it on the market with all rights and obligations. To this end, the legal manfucturer demonstrates that his product meets a number of requirements of the MDR. For this, the manufacturer
- conducts a clinical evaluation,
- establishes a risk management system
- meets the General Safety and Performance Requirements (GSPR),
- establishes a quality management system
- prepares instructions for use and labeling
- prepares technical documentation
- carries out a series of registrations
- establishes special functions, and
- provides for adequate liability coverage.
The practical implementation of these tasks depends on the product characteristics, the project status and the circumstances of a company. We perform a gap analysis and discuss in detail which delta is to be filled and how, which documents apply, and which test tasks are required.
Conformity assessment
The manufacturer declares the conformity of the product after having applied a conformity assessment procedure. The MDR describes several possible procedures here. The choice depends on the type of medical device and its risk class. For medical devices with a risk class greater than I, a Notified Body is involved. We support the selection of a suitable conformity assessment procedure, the analysis of the resulting requirements and the cooperation with a Notified Body.
Post-marketing surveillance
The manufacturer establishes a process to monitor his medical device on the market, to cooperate with the competent authorities and the Notified Body and, if necessary, to report serious incidents (Post-Market Surveillance and Vigilance). This includes post-market clinical follow-up. The analysis of these steps is also part of the CE roadmap.
Market access
The manufacturer affixes the CE marking and may place the medical device on the Union market. This often raises specific questions relating to the type of product, the reimbursement channel, the market segments or the business model. In many cases, these questions can already be considered during the approval of a medical device. Typical examples are the proof of medical benefit as part of the clinical evaluation as a basis for the reimbursement or the data protection and cybersecurity requirements for Digital Health Applications (DiGA). We discuss these synergies and incorporate them into the CE roadmap.
The CE Roadmapping Process
To elaborate the CE roadmap, we follow a standardized procedure in 5 steps:
- Project status: CE roadmapping starts with a joint (online) workshop to discuss the nature of the project and the current status in detail. The goal is to develop a common understanding about the project. We also determine what further information we need to develop the CE roadmap.
- Gap analysis: Here, the comparison is made between actual and target with regard to the approval requirements according to MDR and the required documentation. This requires a draft definition of the intend purpose, the support for qualification as a medical device, and justification of a risk class.
- Roadmapping: This is followed by the preparation of a roadmap that describes the exact path to CE marking of a product. The roadmap includes an estimation of workload, costs, times and required competences.
- Report: The CE roadmap is drawn up and documented in an iterative process.
- Implementation: In a second (online) workshop, we discuss the key implementation steps, including risk assessment and recommendations for further action.
The result of the CE roadmap
The CE Roadmap report follows the outline from the above 10 steps. The analysis results are linked to an estimate of the expected workload and include information on the following aspects:
Specific requirement
Reference in the MDR (or another legal basis, if applicable)
relevant guidances, standards or other rules for implementation
respective workload
In addition, the CE Roadmap contains an estimate of further costs, such as for licenses, registrations, testing services or the involvement of a Notified Body, as well as an estimate of the total costs. The CE roadmap concludes with recommendations for further implementation and, if necessary, comments on specific aspects of the project.
The benefits of the CE roadmap for medical device manufacturers
Medical device manufacturers have to take high risks to bring innovations to market. Requirements and bureaucracy hinder market access. The MDR, that has been in force since 2021, has made the situation considerably more difficult.
The MDR has greatly increased the effort required for CE marking of medical devices. This makes it all the more important to plan in detail what a manufacturer will have to do in terms of effort and methodological issues. Many problems can be avoided at an early stage if regulatory requirements are taken into account right from the start and undesirable developments are avoided. At this point, the CE roadmap provides essential information and also helps to correctly assess the economic risks of the project.
Smaller, young or industry-new technology companies also face particular challenges when it comes to medical device approval. Often, the projects are financed by external investors. Here, the CE roadmap helps to make correct assumptions when presenting the financing and to create confidence among the financiers. The effort required for approval is often significantly underestimated.
Conclusion
The CE roadmap is a practice-oriented approach for planning the approval effort for a medical device at an early stage. In this way, the risks and feasibility of a project can be better assessed and expensive mistakes can be avoided. We would be happy to help you with the implementation of your product approval.
