A notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before they are placed on the market.
These bodies are authorised to carry out tasks related to the conformity assessment procedures laid down in the relevant legislation where third party intervention is required.
The European Commission publishes the list of these notified bodies in the NANDO information system.
The notified body authorises the product manufacturer to place the CE mark on its certified products, thus allowing them to be placed on the market and to circulate freely within the EU.
The Court of Justice of the European Union has had to determine the liability of notified bodies.
Referred to by Ms SCHMITT, a German national and a holder of IMGHC prostheses manufactured by PIP, the CJUE handed down decision C-219/15 of 16 February 2017, which sets out the liability regime for notified bodies in relation to medical devices as follows :
‘where there is evidence to suggest that a medical device may not comply with the requirements arising from Directive 93/42, that body must take all the necessary measures to fulfil the obligations laid down in that Article 16(6), as well as those set out in paragraph 41 of this judgment.’ (§47)
The CJUE concludes that:
‘The notified body is not generally required to carry out unannounced inspections, to check the devices and/or to examine the manufacturer’s commercial documents. However, where there is evidence to suggest that a medical device may not comply with the requirements of Directive 93/42, that body must take all necessary measures to fulfil its obligations under Article 16(6) of that Directive and points 3.2, 3.3, 4.1 to 4.3 and 5.1 of Annex II thereto.’ (§48)
The French Court of Cassation adopted this case law, in application of the principle of primacy of EU law, and ruled in the same case initiated against the notified body of the manufacturer PIP that :
‘It follows from this decision that in the presence of indications suggesting that a medical device does not comply with the requirements arising from Directive 93/42, a notified body is required to carry out an inspection of the medical devices or of the manufacturer’s documents listing the purchases of raw materials or to carry out unannounced visits.’ (Cass Civ 2 10 October 2018 n° 15-26093)
In case of non-conformity of the product with the European regulatory provisions, the notified body must use all the prerogatives entrusted to it by the European legislation in order to fully exercise its mission of general interest of surveillance and control of the manufacturer and the certified product.
Le Tutour Avocats currently represents 1.300 plaintiffs against TÜV, the notified body of the medical device manufacturer PIP.