Medical Device Classification

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.

The sequential stages of human testing required before a new drug or medical device can receive regulatory approval. Phase I assesses safety in a small group, Phase II evaluates efficacy and dosing, Phase III confirms effectiveness in large populations, and Phase IV involves post-market surveillance.

The convergence of digital technologies with healthcare, encompassing telemedicine, electronic health records, wearable devices, AI-assisted diagnostics, digital therapeutics, and health data analytics. Digital health companies create significant intangible asset value through proprietary algorithms, patient data assets, regulatory approvals, and clinical evidence — all of which require specialist valuation approaches.

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 regulatory process by which a pharmaceutical product receives authorisation for commercial sale, granted by agencies such as the FDA (US), EMA (EU), and MHRA (UK). Drug approval requires demonstration of safety, efficacy, and manufacturing quality through preclinical studies and clinical trials.

An international regulatory framework developed by the Basel Committee on Banking Supervision that sets minimum capital requirements, leverage ratios, and liquidity standards for banks. Basel III was introduced in response to the 2008 financial crisis and requires banks to hold higher-quality capital (primarily Common Equity Tier 1) against risk-weighted assets, including operational risk and market risk.

A chronological record of system activities, transactions, or document changes that provides a verifiable history of who did what, when, and why. Audit trails are essential for regulatory compliance, fraud detection, and internal controls, and are required by standards including SOX, GDPR, and ISO 27001.

The application of biological sciences to develop products, processes, and services across sectors including pharmaceuticals, biotechnology, medical devices, agricultural technology, and environmental science. Biosciences companies are among the most intangible-asset-intensive businesses in the global economy, with value concentrated in patents, regulatory approvals, clinical trial data, proprietary compounds, and specialised human capital.