Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.
We are repeatedly asked 2 questions at this point:
- What requirements must a product fulfil in detail?
- What does it cost to implement these requirements?
A “quick answer” to these important questions is not possible in most cases. The product-specific requirements differ too much from one medical device to another. In addition, there are differences between the companies and the processes, experience and competences available there.
For this reason, we have developed the “CE Roadmap”. The CE Roadmap allows a precise statement of the regulatory requirements for a particular product. This requirement profile is supplemented by a corresponding cost planning for implementation and approval. In addition, the CE Roadmap gives practical recommendations on the market access of a medical device, on processing periods or also on the cooperation with Notified Bodies.
In this article, we present the process of CE roadmapping and the benefits for manufacturers of medical devices.
- The structure of the CE Roadmap
- The CE Roadmapping Process
- The result of the CE Roadmap
- The benefits of the CE Roadmap 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 into the European market:
- Use case: what is the specific use case?
- Intended purpose: what exactly is the product intended to do?
- Qualification: is the product a medical device?
- Legal bases: which are relevant?
- Risk class: what is the medical device’s risk class?
- Actors: who takes on which task?
- Obligations of the manufacturer: Which requirements must be fulfilled in detail?
- Conformity assessment: how is conformity shown?
- Post-market surveillance: how is the product monitored on the market?
- Market access: what special considerations must be taken into account when placing a product on the market?
The following sections discuss what these 10 steps involve in detail.
Technology developments can have a platform character, so that different medical use cases are possible. If necessary, we consider which use case seems most promising and should be pursued for the CE roadmap. If applicable, there are several use cases with different requirements. We analyse a use case based on a mapping of problem, solution and benefit and focus it on the respective medical user or target groups.
The intended purpose specifies for which a product may and may not be used. It is the basis for all subsequent approval steps and is therefore of essential importance. We analyse the intended purpose for suitability and conformity. If desired, we can assist with a draft formulation.
By comparing the intended purpose with the definition of medical devices in the MDR, we discuss whether or not the device is a medical device. Often, alternative use cases can be demonstrated. This can result in other procedures, i.e. the product can be classified in a different risk class or be placed on the market as a non-medical device. This usually reduces the effort many times over.
In addition to the requirements of the MDR, further requirements from a multitude 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.
The MDR provides 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.
The MDR defines economic actors who have different rights and obligations. The question of the constellation of actors in which a product is developed and made available on the market decisively determines the marketing costs incurred. This must be refinanced on the market. We therefore discuss the constellation of actors as part of a viable business model.
Obligations of the manufacturer
The legal manufacturer according to the MDR is fully responsible for the respective product and places it on the market with all rights and obligations. To this end, he demonstrates that his product fulfils a number of requirements of the MDR by:
- carrying out a clinical evaluation,
- setting up a risk management system,
- fulfilling the general safety and performance requirements,
- establishing a quality management system,
- preparing an instruction manual and a label,
- prepares a technical documentation,
- carries out various registrations,
- establishes some „special functions“ and
- provides for appropriate liability coverage.
The practical implementation of these tasks depends on the product characteristics, the project status and the company itself. We conduct a gap analysis and discuss in detail which delta needs to be filled and how, which documents apply and which testing is required.
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 higher 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.
The manufacturer sets up a process to monitor his medical device on the market, to cooperate with the competent authorities and the Notified Body and to report serious incidents if necessary (Post-Market Surveillance and Vigilance, PMSV). This also includes post-market clinical follow-up. The analysis of these efforts is also part of the CE roadmap.
The manufacturer affixes the CE mark and is allowed to place the product as a medical device on the European market. This often raises specific questions arising from the nature of the product, the reimbursement channel, the market segments or the business model. In many cases, these questions can already be usefully considered during the regulatory process for a medical device. Typical examples are the proof of medical benefit as part of the clinical evaluation with a view to reimbursement of services or the data protection and cyber security requirements for Digital Health Applications (DiGA). We discuss these synergies and have them included in the CE roadmap.
The CE Roadmapping Process
To work out the CE roadmap, we follow a standardised 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 aim is to develop a common understanding of the project. In addition, we determine what further information we need for the elaboration of the CE roadmap.
- Gap analysis: Here, the comparison is made between actual and target with regard to the regulatory requirements according to MDR and the required documentation. This needs a draft formulation for an intended purpose, support for qualification as a medical device and the rationale for 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 essential implementation steps incl. 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 results of the analysis 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)
- associated guidance, standards or other rules for implementation
- associated workload
In addition, the CE Roadmap contains an estimate of further costs, such as for licences, 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, explanations 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 has made the situation far more difficult. It has sharply increased the effort required for CE marking of medical devices. This makes it even more important for manufacturers to plan in detail what they 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 sector-new technology companies also have special challenges when it comes to the approval of medical devices. Often the projects are financed by external donors. Here, the CE roadmap helps to make correct assumptions when presenting the financing and to create confidence among the funders. The effort required for approval is often significantly underestimated.
The CE roadmap is a practice-oriented approach for planning the regulatory effort for a medical device at an early stage. This makes it easier to assess the risks and feasibility of a project and to avoid expensive mistakes. We are happy to help you with the implementation of your product approval. Please, feel free to contact us for further details.