Medical Device Regulation (MDR)

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 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 total fee charged to a merchant for processing a payment card transaction, expressed as a percentage of the transaction value plus a fixed per-transaction fee. The MDR comprises three components: the interchange fee (paid to the issuing bank), the card network assessment fee (paid to Visa/Mastercard), and the acquirer's markup.

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 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.

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 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.

The EU directive (2015/2366) that regulates payment services and payment service providers, mandating strong customer authentication, open banking through account access APIs (XS2A), and enhanced consumer protection. PSD2 has fundamentally reshaped the European payments landscape by requiring banks to provide licensed third parties with access to customer account data and payment initiation capabilities.