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PIP Breast Implants, the EU's New Approach for Goods and Market Surveillance by Notified Bodies

Van Leeuwen, Barend



With the New Approach for goods, the EU has created a regulatory framework for placing products on the market in which both public and private parties have an important role to play. The various cases which have been brought after the PIP breast implants scandal show the difficulties with trying to link this ex ante regulatory framework to potential liability for defective products. National courts have reached different conclusions about the scope of the obligations of certification bodies in the New Approach. Since these issues are about the fundaments of the construction of the New Approach, it would be desirable for the ECJ, and perhaps even the European legislator, to get involved.

Journal Article Type Article
Acceptance Date Jun 1, 2014
Online Publication Date Jan 20, 2017
Publication Date 2014-09
Deposit Date Sep 8, 2017
Journal European Journal of Risk Regulation
Print ISSN 1867-299X
Electronic ISSN 2190-8249
Publisher Cambridge University Press
Peer Reviewed Peer Reviewed
Volume 5
Issue 03
Pages 338-350
Public URL