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 E.U. market, with the applicable essential technical requirements. These essential requirements are publicised in European Directives or Regulations. A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; a Notified Body can use the same harmonised standards to assess the conformity to these essential requirements. Conformity assessment can include inspection and examination of a product, its design, and the manufacturing environment and processes associated with it. For example, a notified body may designate that a medical device conforms to the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices. With this Declaration of Conformity, the manufacturer can label the product with the CE Mark, which is required for distribution and sale in the E.U. Additionally, the E.U. member state accrediting the notified body will then inform the European Commission that the product complies with set standards (or not).
More generally, a notified body is an independent, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined standards and regulations, but also to provide an official certification mark or a declaration of conformity.
Criticism and improvement
- "a lack of uniformity in certification procedures and in the application of harmonised standards";
- "the varying levels of expertise among notified bodies," including "differences in test results"; and
- "encouraging 'forum shopping' by sponsors to identify those notified bodies with the most lax operating standards."
Discussion of further expanding coordination groups of notified bodies for different product areas, improving marketing surveillance, and making participation in standardization and coordination activities mandatory began within E.U. member states. However, more criticism would arise out of the Poly Implant Prothèse (PIP) scandal in early 2010, when media revealed that the French manufacturer of silicone gel breast implants had been using unapproved in-house manufactured industrial-grade instead of medical-grade silicone for most of its implants. 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. However, TÜV stated "its remit was to check the production process, not the content of the silicone."
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 E.U. by improving decision making among the national regulatory authorities." Then in February 2012, European Health and Consumer Policy Commissioner John Dalli called upon E.U. 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.
As of February 2016, 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."
The European Union maintains an online database of accredited Notified Bodies. The Nando (New Approach Notified and Designated Organisations) Information System allows citicens and economic entities to search and validate the status of the notification of a Notified Body for certain regualtions and directives.
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