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A notified body is an organization designated by an EU Member State (or by other countries through specific agreements) to assess the conformity of certain products before they are placed on the market. These bodies are authorized to carry out tasks related to conformity assessment procedures as set out in applicable legislation when third-party intervention is required.
The European Commission publishes the list of notified bodies in the NANDO information system.
The notified body authorizes the certified manufacturer to affix the CE marking to its certified products, thereby allowing their free movement and market access within the EU.
The Court of Justice of the European Union (CJEU) has had to define the liability regime of notified bodies.
Following a preliminary ruling request submitted by Ms. Schmitt, a German national and recipient of IMGHC implants manufactured by PIP, the CJEU issued judgment C-219/15 on 16 February 2017, which sets out the liability framework for notified bodies in relation to medical devices:
“Where there are indications that a medical device may not comply with the requirements arising from Directive 93/42, the notified body must take all necessary steps to fulfil its obligations under Article 16(6) and as explained in paragraph 41 of the present judgment.” (§47)
The CJEU further held:
“The notified body is not, as a rule, required to carry out unannounced inspections, examine devices, or review the manufacturer’s commercial documents. However, when indications suggest that a medical device may be non-compliant with Directive 93/42, the notified body must take all necessary steps to fulfill its obligations under Article 16(6) of that directive and under points 3.2, 3.3, 4.1 to 4.3, and 5.1 of Annex II to said directive.” (CJEU judgment cited above, §48) (Exhibit No. 51 bis, p. 7–8)
The French Court of Cassation endorsed this case law in application of the principle of primacy of EU law and ruled, in the same case brought against the notified body of PIP’s manufacturer, that:
“This decision implies that, where there are indications suggesting a medical device may not comply with the requirements of Directive 93/42, a notified body is obliged to inspect the medical devices or the manufacturer’s procurement documents for raw materials, or to carry out unannounced visits.”
(Cass. civ. 2e, 10 October 2018, No. 15-26093)
In the event of non-compliance of a product with EU regulatory provisions, the notified body must use all powers entrusted to it by European legislation in order to fully carry out its public-interest mission of monitoring and inspecting the certified manufacturer and product.
Le Tutour Avocats represents 1,200 claimants in legal action against TÜV, the notified body for PIP, manufacturer of the defective medical devices.
If you need information or advice on the liability of notified bodes under French and EU law, please do not hesitate to contact us, as we have significant experience of this specific liability regime.