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 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.

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.

A tradable certificate representing the right to emit one tonne of carbon dioxide equivalent, or a verified reduction or removal of one tonne of CO2 equivalent from the atmosphere. Carbon credits are traded on compliance markets (such as the EU Emissions Trading System) and voluntary markets, and represent an emerging class of intangible asset with growing valuation complexity as climate regulation intensifies.

A cybersecurity framework based on the principle that no user, device, or system should be automatically trusted, whether inside or outside the network perimeter. Zero trust requires continuous verification of identity and access rights for every request, micro-segmentation of network resources, and least-privilege access controls.

What role does data privacy play in building customer trust?

Data privacy is table-stakes for trust. Customers must know data is secure, encrypted, not sold, and handled according to GDPR and other regulations.

Is Opagio data secure and encrypted?

Opagio uses industry-standard encryption, secure APIs, and access controls. However, you should review our Data Privacy Policy for full details before uploading sensitive company information.

How does GDPR affect the valuation of data and customer relationship assets?

GDPR constrains data monetisation, requires consent for data processing, and introduces significant penalty risk — all of which affect the valuation of data assets and customer relationship intangibles.