Notified body

A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements.

Investigators also brought criticism down on notified body TÜV Rheinland for issuing a certificate of quality for a production process that didn't include the in-house industrial-grade silicone.

"[7][12] Then in February 2012, European Health and Consumer Policy Commissioner John Dalli called upon EU member states to take a hard look at the regulatory system, including how notified bodies play a part.

[13] The European Commission acted, that September revealing its proposed changes to medical device regulation, including expanded requirements on notified bodies, to be published in 2014 and go into effect in 2017.

[14] However, the commission also opted to instate additional reforms — separate from its draft regulations — that would go into effect much sooner, asking notified bodies to perform unannounced visits to manufacturers and expand their device testing standards.

[7][15] In late 2013 and early 2014, a French court ordered (and later upheld its decision) that notified body TÜV Rheinland pay restitution to those affected by the PIP scandal.