Clinical Trial Phases

The regulatory categorisation system that assigns medical devices to classes based on their risk to patients, which determines the level of regulatory scrutiny required for market approval. The EU MDR uses four classes (I, IIa, IIb, III) while the FDA uses three (I, II, III).

The regulatory authorisation granted by the US Food and Drug Administration permitting a medical device to be marketed in the United States, typically through the 510(k) premarket notification pathway for devices that are substantially equivalent to an existing legally marketed device. FDA clearance is distinct from FDA approval (required for higher-risk Class III devices via the Premarket Approval pathway) and represents a significant regulatory intangible asset.

A regulatory status granted to drugs developed to treat rare diseases affecting small patient populations, providing incentives such as market exclusivity (7 years in the US, 10 years in the EU), tax credits on clinical trial costs, and reduced regulatory fees. Orphan drug designation significantly enhances the economic value of a pharma intangible asset by creating protected market positions.

The portfolio of drug candidates at various stages of research, development, and regulatory approval within a pharmaceutical or biotechnology company. The pharma pipeline is a critical intangible asset, with each compound's value dependent on its probability of regulatory approval, expected market size, patent protection remaining, and development costs to completion.

The EU regulatory framework (Regulation 2017/745) governing the design, manufacture, and distribution of medical devices in the European market, which replaced the Medical Devices Directive (93/42/EEC) with significantly stricter requirements. MDR imposes enhanced clinical evidence requirements, more rigorous conformity assessment procedures, a Unique Device Identification system, and comprehensive post-market surveillance obligations.

A mandatory conformity marking for products sold within the European Economic Area, indicating that the product meets EU health, safety, and environmental protection requirements. For medical devices, CE marking under the Medical Device Regulation (MDR 2017/745) requires conformity assessment by a Notified Body, clinical evaluation, and ongoing post-market surveillance.

The framework of policies, procedures, and organisational structures that guide the responsible development, deployment, and monitoring of artificial intelligence systems. AI governance encompasses risk management, ethical guidelines, regulatory compliance, model validation, and accountability mechanisms.

A biological medicine that is highly similar to an already approved reference biological product, with no clinically meaningful differences in safety, purity, or potency. Unlike generic small-molecule drugs, biosimilars cannot be exact copies due to the complexity of biological manufacturing processes and require their own clinical trials to demonstrate similarity.

What does AI due diligence involve for investors?

AI due diligence evaluates a company's AI capabilities, data assets, model performance, technical debt, governance practices, talent dependency, and the defensibility of its AI competitive advantages.

What AI governance frameworks should companies adopt?

Companies should adopt AI governance frameworks covering ethical principles, risk management, transparency, accountability, and compliance — drawing from standards like the EU AI Act, NIST AI RMF, and ISO/IEC 42001.

What is responsible AI and why does it affect enterprise value?

Responsible AI is the practice of developing and deploying AI systems that are fair, transparent, accountable, and privacy-preserving — it affects enterprise value by reducing regulatory risk and building stakeholder trust.