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Nevertheless, regulatory issues are still often addressed relatively late in the process by many start-ups. Discussions with a Notified Body often only begin once product development is well advanced and the certification process is imminent. Structured dialogue at an earlier stage, on the other hand, can help to verify regulatory assumptions, reduce uncertainties, and make business decisions more robust.

This is demonstrated in TÜV SÜD’s new white paper, ‘Leaving the Regulatory Ivory Tower – How early notified body dialogues reduce business risks’. In the paper, TÜV SÜD describes four specific dialogue formats that start-ups can utilise during the development phase, and well before the certification process begins. The focus is on clarifying the regulatory framework for their own product and business model at an early stage. This enables start-ups to make more informed decisions, allocate resources more effectively, and ensure that their development is more closely aligned with their business objectives.

Four questions that medtech start-ups should clarify at an early stage

1. Is our regulatory and clinical roadmap realistic?
Timetables for ISO 13485 certification, clinical trials, technical documentation and Notified Body assessment are often estimated based on the experiences of other start-ups. Early dialogue can help to identify critical dependencies, regulatory milestones and necessary adjustments to assumptions at an early stage, thereby making them more robust. This provides greater planning certainty and enables development resources, time and capital to be allocated more effectively.

2. Do the intended purpose and risk class align with our business model?
The intended purpose and the resulting risk class are closely linked to a product’s commercial objectives and business case. Aligning them early on can help to clarify regulatory requirements and avoid missteps that only become apparent during certification or even afterwards, when commercial success fails to materialise. Thus, the regulatory perspective becomes an integral part of the product and business strategy, enabling its incorporation into the development of commercial objectives at an early stage.

3. Can we demonstrate our regulatory maturity even before CE certification?
‘Regulatory maturity’ develops throughout the entire development process and is evident even before certification. It encompasses appropriate expertise, quality management, regulatory processes and robust evidence of product conformity, among other things. For investors, the ability to demonstrate how a start-up systematically addresses regulatory risks and the progress made towards compliance before certification can be a significant indicator. Thus, regulatory maturity becomes part of a company’s credibility, demonstrating that a start-up is developing technology while also systematically taking into account the regulatory requirements for its successful marketing.

4. Does our Notified Body also support our growth after certification?
Cooperation with the Notified Body on regulatory matters does not end with CE certification. This is particularly relevant for medical device software, where new functions, changes to algorithms or changes to the intended purpose may raise questions about whether a change is substantial, and the level of involvement required from the Notified Body when implementing the changes. Early discussion of such processes can help determine how well the Notified Body’s processes align with the company’s change objectives, and establish the conditions for agile product development. For start-ups, therefore, choosing a Notified Body is also a strategic decision that can influence how flexibly the company can develop its product further after market entry and grow its business.

Regulatory engagement as a signal to investors

For investors, how a start-up handles regulatory risks early on can serve as an additional indicator of the quality of the company’s planning. If regulatory and clinical roadmaps have been scrutinised, if commercial assumptions have been assessed against their regulatory basis and if progress can be substantiated by verifiable evidence, this creates a more robust picture of a company’s regulatory maturity. Early regulatory dialogues can therefore demonstrate how systematically a start-up identifies, assesses, and incorporates business risks into its corporate planning.

“Regulatory maturity is not a characteristic that a start-up only achieves upon CE certification. It develops throughout the entire journey from product concept to market entry and beyond,” says Malte Knowles Schmidt, Global Portfolio Manager for Medical Device Software, AI and Cybersecurity at TÜV SÜD. “The earlier regulatory assumptions are reviewed, the sooner start-ups can identify where regulatory uncertainty could develop into a concrete business risk. This creates a better foundation for product decisions, market entry planning and discussions with investors.”

The white paper highlights early dialogues as a tool for corporate risk management. It focuses on how regulatory uncertainty can be addressed at an early stage as part of business planning, and how assumptions can be underpinned with more robust information. “Leaving the Regulatory Ivory Tower – How early notified body dialogues reduce business risks” uses four structured dialogue formats to demonstrate how start-ups can address regulatory risks from the early development phase through to CE certification and beyond as the business grows: White paper: Leaving the regulatory ivory tower | TÜV SÜD

Media interview offer:

What regulatory questions should medtech start-ups ask before applying for certification?
Malte Knowles Schmidt is available for an in-depth interview. With many years of experience in product leadership roles in the fields of Class III implants, hospital software and digital health, he understands both the perspective of both start-ups and the requirements for the regulatory development and certification of medical devices.

Possible topics for discussion:

• When should a start-up first speak to a Notified Body?
• Which regulatory issues can influence a product’s business case?
• What can investors infer from a start-up’s regulatory maturity?
• Why can the choice of a Notified Body also be relevant to a start-up’s future capacity for innovation and growth?
• How can regulatory uncertainty be reduced without slowing down a start-up’s agile development process?