Notified Bodies

Notified Bodies
Name	Notified Bodies
Formation	varies by member state
Purpose	conformity assessment for regulated products
Region	European Union, European Economic Area

Notified Bodies

Notified Bodies perform conformity assessment for regulated products within the European Union and European Economic Area, enabling market access under harmonised laws such as the Medical Devices Regulation, the Machinery Directive, and the Construction Products Regulation. They are independent organisations designated by national authorities to assess conformity with standards created by institutions such as the European Commission, the European Parliament, and the Council of the European Union. Major economic sectors interacting with these organisations include medical devices, automotive components, and construction materials, involving stakeholders like the European Medicines Agency, the European Chemicals Agency, and national ministries.

Overview

Notified Bodies operate at the intersection of regulatory implementation, standardisation, and trade facilitation; examples of affiliated institutions include European Commission, European Parliament, Council of the European Union, European Free Trade Association, and European Economic Area. They evaluate conformity with harmonised standards published by bodies such as European Committee for Standardization, European Committee for Electrotechnical Standardization, and industry-specific organisations like CEN/CENELEC and ISO. In practice, producers from firms like Siemens, Bayer, Philips, General Electric, and ABB engage Notified Bodies to obtain certificates required by directives and regulations administered by agencies such as European Medicines Agency and European Chemicals Agency. Notified Bodies frequently collaborate with notified testing laboratories, certification bodies, and inspection bodies linked to networks including International Organization for Standardization, International Electrotechnical Commission, and European Cooperation for Accreditation.

Legal Framework and Designation

Designation and tasks are defined by EU legal acts such as the New Legislative Framework (EU), sectoral measures like the Medical Devices Regulation (EU) 2017/745, the In Vitro Diagnostic Regulation (EU) 2017/746, the Machinery Directive 2006/42/EC, and the Construction Products Regulation (EU) No 305/2011. National authorities of member states such as Bundesministerium für Gesundheit (Germany), Agence nationale de sécurité du médicament et des produits de santé (France), Medicines and Healthcare products Regulatory Agency (United Kingdom), and Istituto Superiore di Sanità (Italy) notify competent bodies to the European Commission for entry in the NANDO database. Designation criteria reference standards from International Organization for Standardization, European Cooperation for Accreditation, and instruments developed by the European Accreditation (EA) network. Legal challenges and interpretation issues have been litigated before the Court of Justice of the European Union.

Responsibilities and Activities

Core responsibilities include conformity assessment, type examination, quality management system audits, product testing oversight, and issuing certificates required under instruments such as the Low Voltage Directive, EMC Directive, and the Radio Equipment Directive. Activities are performed by assessors often trained in standards like ISO 9001, ISO 13485, and ISO/IEC 17021; they liaise with economic operators including manufacturers like Roche, Medtronic, Bosch, Renault, and importers and distributors across markets regulated by European Chemicals Agency and sectoral authorities. Notified Bodies may conduct factory inspections, review technical documentation, and oversee post-market surveillance obligations enforced by competent authorities such as Paul-Ehrlich-Institut and Robert Koch Institute in health-related fields. They interact with conformity assessment routes mandated by instruments like the CE marking framework and sometimes coordinate with supranational purchasers such as European Investment Bank when procurement standards require certification.

Accreditation and Oversight

Accreditation and oversight mechanisms involve national accreditation bodies—examples include Deutsche Akkreditierungsstelle (DAkkS), UK Accreditation Service (UKAS), COFRAC (France), and ACCREDIA (Italy)—which apply criteria from ISO/IEC 17065 and ISO/IEC 17021. Oversight is executed via peer reviews, assessment reports, and notifications maintained in EU registries such as the NANDO information system overseen by the European Commission. International oversight and mutual recognition draw on organisations like International Laboratory Accreditation Cooperation and European Cooperation for Accreditation. Enforcement actions, suspension, or withdrawal of designation can involve national ministries and have been subject to review by the European Court of Auditors and litigation in the Court of Justice of the European Union.

Role in EU Directives and Regulations

Notified Bodies are essential implementers of EU harmonisation policy embodied in acts including the Medical Devices Regulation (EU) 2017/745, In Vitro Diagnostic Regulation (EU) 2017/746, Machinery Directive 2006/42/EC, and the Construction Products Regulation (EU) No 305/2011. They enable manufacturers such as Johnson & Johnson, Pfizer, Thyssenkrupp, and Vestas to affix conformity markings like CE marking that facilitate internal market circulation. Their assessments reference harmonised standards issued by CEN, CENELEC, and international standards bodies like ISO and IEC, and coordinate with regulators including the European Medicines Agency and national competent authorities responsible under sectoral rules. Disputes over interpretation of directives have reached the Court of Justice of the European Union, while policy reforms engage institutions such as the European Parliament and the European Commission.

Controversies and Criticisms

Criticisms include alleged conflicts of interest involving contracting models, high-profile device safety incidents implicating certification processes for manufacturers like Philips Respironics and Medtronic-supplied devices, and uneven designation practices across member states such as controversy in Germany and Belgium. Evaluations by bodies such as the European Court of Auditors and reporting by media outlets and non-governmental organisations like European Public Health Alliance have highlighted concerns about transparency, capacity bottlenecks, and varying interpretation of standards. Calls for reform have involved stakeholders including the European Parliament, consumer organisations like BEUC, and professional associations such as European Association of Notified Bodies. Responses have included tightened accreditation by DAkkS and policy initiatives from the European Commission to reinforce supervision, interoperability with the Eudamed database, and harmonise designation criteria.

Category:European Union regulatory bodies