Notified body

A notified body is a conformity assessment body designated by the competent authority of a Member State and notified to the European Commission and the other Member States, in order to take part in the procedures for placing medical devices on the market. Its status is laid down by Regulation (EU) 2017/745 and, for in vitro diagnostics, by Regulation (EU) 2017/746. In France, the authority responsible for designating and monitoring notified bodies is the ANSM.

Designation and its requirements

Designation requires compliance with requirements of independence, impartiality, competence and confidentiality. Under the 2017 Regulations, it is subject to a joint assessment involving the national authority, experts from other Member States and the Commission, and each body may act only for the categories of devices and the procedures covered by its notification. The list of bodies and the scope of their notification are published in the European NANDO database. The small number of bodies designated under the new Regulations has created a bottleneck, which led to the extension of the transition periods.

Tasks

The body audits the manufacturer’s quality management system, examines the technical documentation and the clinical evaluation where required, and issues certificates valid for a maximum of five years, which are renewable. It carries out surveillance for the duration of the certificate, conducts audits, including unannounced audits, and may suspend, restrict or withdraw a certificate where the requirements are no longer met. Without a valid certificate, the manufacturer of a device subject to its involvement can no longer affix the CE marking.

Liability of the notified body

The relationship between the manufacturer and the body is contractual, and disputes arising from it, for example concerning the refusal or withdrawal of a certificate, are subject first to the appeal procedures provided by the body and then to the competent courts. The Court of Justice has also accepted that a notified body may incur liability towards patients where it fails in its duty of vigilance despite evidence suggesting that a device may not be compliant, the conditions of such liability being a matter for national law. Finally, the body has access to sensitive technical information of the manufacturer, protected by a duty of confidentiality and, where appropriate, as a trade secret.

Key points

The notified body is the manufacturer’s mandatory counterpart for most medical devices, and its availability determines the timetable for placing on the market. Its certificate is temporary and may be suspended or withdrawn. The exact scope of the chosen body’s notification should be checked, certificate renewal lead times should be anticipated and the confidentiality of the information disclosed should be governed by contract.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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