The notified bodies system used by the European Union has been publicly criticized in some capacity since at least 2008 for issues such as: • "a lack of uniformity in certification procedures and in the application of harmonised standards"; The revelation had a ripple effect, causing both more criticism about the responsibilities of notified bodies and the regulatory process in general and more corrective action. The Central Management Committee was created in September 2010 "to develop the effectiveness of the regulatory system on medical devices in the EU by improving decision making among the national regulatory authorities." 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. His recommendations included properly verifying whether a notified body is capable of accurately assessing medical devices, improving how conformity assessments are conducted, and developing tools to enhance medical device
traceability. 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. 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. At the same time the NB-MED (European Forum of Notified Bodies Medical Devices) coordination revised their code of conduct due to criticism. 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. However, this decision and a similar case in Germany has created questions about how much liability should be applied to notified bodies for patient devices found to be dangerous despite previous notified body assessment. The German case against TÜV was dismissed initially and on appeal in district and regional courts, and an appeal to a German federal court resulted in referral of the case to the
Court of Justice of the European Union (CJEU) for clarification "on three issues on the interpretation of the Medical Devices Directive." Additionally, the original restitution decision by French courts was appealed and overturned on July 2, 2015, forcing affected patients to return their interim compensation, leaving many patients without recourse. , the German case is ongoing, waiting for CJEU input. Rudd-Clarke and Page postulated in December 2015 that if "the CJEU decides that notified bodies are under a duty to protect patients, the practical effects could be that the CE certification process slows down, which is likely to have a detrimental impact on the cost for manufacturers of getting a product to market, while notified bodies may face a significantly increased
litigation risk for failure to comply with their duties." Regulations governing medical device manufacturers and Notified Bodies operating in the medical device field were tightened with the
Medical Device Regulation of 2017. ==Nando database==