Innovative medical devices, in vitro diagnostic medical devices, software solutions, and data-driven technologies often emerge at the intersection of medicine, digitalization, AI, the data economy, and clinical practice. As a result, the regulatory path is not determined solely by the MDR or IVDR. Interfaces with other regulatory areas, regulatory requirements for data and AI, market requirements, and strategic product decisions may also be relevant.
What is the Market Access Compass?
The Market Access Compass helps to strategically assess regulatory issues at an early stage and use this assessment to develop a technically sound approach for the development, qualification, classification, and market access of products.
Result
A strategy and analysis process for early-stage regulatory decisions supports the development of a comprehensive and well-founded regulatory understanding for a medical product or technology project.
In particular, the following aspects are considered:
- the medical problem and the relevant healthcare context,
- the technological approach and its regulatory relevance,
- application scenarios and possible usage and healthcare delivery concepts,
- the initial regulatory situation and interfaces with other regulatory areas,
- possible regulatory approaches and paths to conformity assessment,
- intended use, qualification, classification according to the MDR or IVDR,
- essential regulatory requirements, standards, and guidelines,
- next steps for the further implementation of the project.
Procedure
- Discuss the initial situation
Discussion of the medical problem, the technological approach, the product concept, the target market segment, and the current status of the project. - Analyze strategic options
Analysis of potential application scenarios, usage and delivery concepts, as well as possible regulatory classifications. - Assess the overall regulatory situation
Technical assessment of the relevant regulatory framework, particularly the MDR and IVDR, as well as identification of potential interfaces with the AI Act, EHDS, Data Act, data protection, and cybersecurity. - Developing a Regulatory Strategy
Support with intended use, qualification, classification, possible conformity assessment pathways, and essential requirements. - Deriving Recommendations for Action
Summary of the results and the resulting next steps for product development, regulatory implementation, and market access.
The process includes accompanying workshops in which key aspects of the project are discussed collaboratively.
Benefits
- Strategic clarity in an early project phase
- Better alignment of medical needs, technology, and the regulatory pathway
- Early identification of regulatory challenges and scoping issues
- Transparent intended use as the basis for development and market access
- Guidance on qualification, classification, and conformity assessment
- A sound basis for decision-making regarding next steps, timelines, and market access
