CE Marking

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 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 authorisation granted by a government or regulatory body permitting a company to manufacture, market, or sell a product or service in a specific jurisdiction. Regulatory approvals — including drug approvals (FDA, EMA), financial service licences (FCA, MAS), telecommunications licences, and environmental permits — are recognised as contract-based intangible assets in purchase price allocations under IFRS 3 and ASC 805 when they arise from contractual or legal rights.

The General Data Protection Regulation (EU 2016/679), a comprehensive data protection law that governs the collection, processing, and storage of personal data of individuals within the European Economic Area. GDPR imposes strict requirements on data controllers and processors, including lawful basis for processing, data minimisation, breach notification within 72 hours, and fines of up to 4% of global annual turnover for non-compliance.

An EU legislative framework (PSD2, Directive 2015/2366) governing payment services and payment service providers across the European Economic Area. PSD2 introduced requirements for strong customer authentication, mandated open access to payment account data for authorised third parties (enabling open banking), and created new categories of regulated payment institutions.

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 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.

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.