NANDO Information System

NANDO Information System
Name	NANDO Information System
Established	1990s
Jurisdiction	European Union

NANDO Information System

The NANDO Information System is a publicly accessible European Commission database that catalogs conformity assessment bodies, notified bodies, and standards-related information across the European Union, European Economic Area, DG GROW, EFTA, and associated entities. It aggregates formal notifications, accreditation records, and identification numbers to support regulatory compliance under directives and regulations such as the Medical Devices Directive, Construction Products Regulation, and the Machinery Directive. The system interfaces with national authorities, accreditation bodies, and notified bodies to provide centralized verification and transparency for stakeholders including manufacturers, importers, and certification bodies.

Overview

The system functions as a registry linking notified bodies designated by Member State competent authorities to the legal acts that require third-party conformity assessment, such as the In Vitro Diagnostic Medical Devices Regulation and the Toy Safety Directive. It supplies machine-readable identifiers, scopes of notification, and withdrawal notices to users across ECHA, EMA, EASA, and sectoral regulators. By maintaining records for entities accredited by organizations like EA, the database supports interoperability with national registers such as those maintained by the UKAS, DAkkS, and ENAC.

History and Development

The registry originated in the 1990s amid initiatives to harmonize conformity assessment across the Single European Act framework and later under the Treaty of Maastricht and Treaty of Lisbon institutional developments. Early iterations were motivated by directives including the New Approach to Technical Harmonization and Standards and coordination among CEN and CENELEC. Subsequent modernization incorporated digital services aligned with the ISA2 and CEF Digital programs to improve interoperability with platforms like EUROPA and the Internal Market Information System. Major upgrades responded to regulatory crises and reforms, for example revisions following implementation of the Medical Devices Regulation (EU) 2017/745 and the Construction Products Regulation (EU) No 305/2011.

Structure and Content

The registry is organized into datasets that record notified bodies’ identification numbers, scopes of notification, address and contact details, and statuses such as suspended or withdrawn. It cross-references legal instruments including the Low Voltage Directive, Electromagnetic Compatibility Directive, Personal Protective Equipment Regulation, and sector-specific annexes. Metadata standards align with schemas used by European Data Portal, Open Data Directive, and ISO/IEC 17065 frameworks while linking to accreditation references like ISO/IEC 17021-1 and ISO/IEC 17025. The content includes decision dates from competent authorities such as national ministries, entries reflecting judgments influenced by national courts, and notes on market surveillance actions by authorities including OLAF and member state inspectorates.

Access and Usage

Access is provided through a web interface and structured data services enabling queries by notified body number, designation scope, and legal act. Users from industry associations like BusinessEurope, BEUC, and European Small Business Alliance rely on the registry to verify conformity assessment partners before engaging with CE marking procedures. National competent authorities, accreditation entities such as ILAC, and conformity assessment bodies use the system to coordinate designation procedures, exchange notifications under the Mutual Recognition Agreement framework, and support procurement processes influenced by rulings from courts like the Court of Justice of the European Union.

Applications and Impact

The database underpins compliance workflows for manufacturers in sectors spanning pharmaceuticals, aerospace, information technology, and construction by enabling validation of third-party assessment providers. It enhances transparency for importers dealing with non-EU suppliers, aids notified body performance monitoring by national ministries, and informs policy evaluations conducted by institutions such as the European Parliament and European Council. The system has been cited in technical assessments, market surveillance coordination, and enforcement actions where verifying a notified body’s scope or status is decisive, and it facilitates cross-border trade by reducing uncertainty in conformity assurance processes.

Criticisms and Limitations

Critiques focus on data timeliness, completeness, and granularity: stakeholders including BEUC, national ministries, and professional associations have reported delays in reflecting suspensions or withdrawals, occasional inconsistencies with accreditation registers like EA records, and limited machine-readable detail for complex scopes. Legal practitioners and companies point to challenges when historic decisions, litigation outcomes from national courts, or transitional arrangements under regulations such as the Medical Devices Regulation (EU) 2017/745 are not fully annotated. Calls for integration with broader EU digital infrastructure, enhanced API features comparable to ECHA or EMA systems, and stronger governance involving European Ombudsman recommendations have shaped ongoing reform discussions.

Category:European Union databases