A quick reference for common EU compliance and market access terms (with focus on MDR/IVDR).
An EU-based legal/natural person appointed by a non‑EU manufacturer to act on its behalf for specific tasks under MDR/IVDR. The EU AR is a key EU contact point and has defined obligations. See also: EU AR for medical devices.
Often used as a practical synonym for EU Authorised Representative in medical devices context. In EUDAMED, EAR may appear as the “European Authorised Representative” role under the Economic Operator registration.
A party in the medical device supply chain (e.g., manufacturer, authorised representative, importer). EUDAMED uses EO concepts for registration and identification.
The European Database on Medical Devices. It supports registration, transparency and data exchange for MDR/IVDR processes. See: EUDAMED support. Our EO/EAR entry: View in EUDAMED.
Regulation (EU) 2017/745 on medical devices. Sets requirements for placing medical devices on the EU market (including roles such as EU AR and PRRC). See: MDR overview.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDs). See: IVDR overview.
In Vitro Diagnostic medical device.
Person Responsible for Regulatory Compliance. A required role under MDR/IVDR for many manufacturers, ensuring key compliance tasks are appropriately overseen and documented. See: PRRC services.
Quality Management System. A structured set of policies, processes and procedures used by manufacturers to ensure product quality and regulatory compliance.
Set of documents describing the device, its design and manufacturing, risk management, clinical evaluation/performance data, and compliance evidence required under MDR/IVDR.
A document in which the manufacturer declares that the device meets applicable EU requirements and is also responsible for ensuring ongoing conformity.
Unique Device Identification. A system used to identify devices and support traceability. UDI requirements connect with EUDAMED modules and labelling rules.
Activities carried out by the manufacturer to collect and review experience from devices on the market and to determine if corrective or preventive actions are required.
Reporting and follow‑up processes related to serious incidents and field safety corrective actions (FSCA). Requirements depend on device type and situation.
Economic operator roles under MDR/IVDR with specific obligations related to placing devices on the market (importer) and making them available (distributor).
A national authority in an EU Member State responsible for implementing and enforcing MDR/IVDR (market surveillance and regulatory oversight).
Regulation (EC) 1907/2006 concerning Registration, Evaluation, Authorisation and Restriction of Chemicals.
An EU-based representative appointed by a non‑EU manufacturer under REACH to fulfil certain obligations. See: REACH Only Representative.
EU-based Responsible Person under Cosmetics Regulation (EC) 1223/2009, responsible for product compliance and specific market obligations. See: Cosmetics Responsible Person.
Cosmetic Products Notification Portal — an EU notification system for cosmetics. See: CPNP notification support.
A document used in international trade confirming that a product is legally marketed in a country (requirements vary by product type and destination). See: CFS support.
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