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[[File:Conformité_Européenne_(logo).svg|thumb|200px|CE Mark]]
A '''notified body''', in the [[Social:European Union|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.  [[Engineering:Conformance testing|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 [[Medicine:Medical device|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).<ref name="ECBlue14">{{cite book |url=http://ec.europa.eu/DocsRoom/documents/12661/attachments/1/translations/en/renditions/native |format=PDF |title=The 'Blue Guide' on the Implementation of EU Product Rules |publisher=European Commission |edition=1.1 |pages=134 |date=15 July 2015 |accessdate=25 February 2016}}</ref><ref name="">{{cite web |url=http://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies/index_en.htm |title=Notified bodies |work=Growth: Internal Market, Industry, Entrepreneurship and SMEs |publisher=European Commission |date=11 February 2016 |accessdate=25 February 2016}}</ref><ref name="Rudd-ClarkeAProd15">{{cite journal |url=http://www.insiderquarterly.com/a-product-of-our-times |title=A product of our times |author1=Rudd-Clarke, P. |author2=Page, F. |journal=Insider Quarterly |issue=Winter 2015 |date=9 December 2015 |accessdate=25 February 2016}}</ref>

More generally, a notified body is an independent, accredited body which is entitled by an authorized [[Accreditation|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.<ref name="MHRAGuidance13">{{cite web |url=https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/382646/Requirements_for_UK_notified_bodies.pdf |format=PDF |title=Guidance on Legislation: Requirements for UK Notified Bodies |author=Medicines and Healthcare Products Regulatory Agency |publisher=Government of the U.K. |pages=14 |date=November 2013 |accessdate=25 February 2016}}</ref><ref name="GCCGuide08">{{cite web |url=http://www.gso.org.sa/gso-website/gso-website/activities/conformity/technical-regulations-and-guides/guide-on-notified-bodies.pdf |format=PDF |title=Guide for Notified Bodies |author=Standards Office of the General Cooperation Council for the Arab States of the Gulf |publisher=GCC Standardization Organization - GSO |pages=12 |date=26 November 2008 |accessdate=25 February 2016}}</ref>

==Criticism and improvement==
The notified bodies system used by the European Union has been publicly criticized in some capacity since at least 2008<ref name="NoetelConform08">{{cite web |url=http://www.euroshnet-conference.eu/fileadmin/user_upload/content/3_Cracow-2008/7-Noetel-Confomity_assessment-en.pdf |format=PDF |title=Conformity assessment and notified bodies |author=Noetel, K.-H. |publisher=European Conference on Standardization, Testing and Certification |date=11 September 2008 |accessdate=25 February 2016}}</ref><ref name="ChowdhuryEuro14">{{cite book |url=https://books.google.com/books?id=vzS5BAAAQBAJ&pg=PA99 |chapter=Chapter 6: Case Study on Medical Devices Regulation in Europe |title=European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty |author=Chowdhury, N. |publisher=Springer International Publishing Switzerland |location=Cham, Switzerland |year=2014 |pages=99–120 |isbn=9783319045948 |accessdate=25 February 2016}}</ref><ref name="MaxwellTight09">{{cite web |url=http://www.clinica.co.uk/policyregulation/regulation/Tightening-oversight-of-notified-bodies-enough-to-satisfy-critics-181589 |title=Tightening oversight of notified bodies: Enough to satisfy critics? |author=Maxwell, A. |work=Clinica |publisher=Informa PLC |date=30 November 2009 |accessdate=25 February 2016}}</ref><ref name="ShurenFDA12">{{cite web |url=https://www.fda.gov/NewsEvents/Testimony/ucm297418.htm |title=FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients (JS) |author=Shuren, J. |work=Testimony |publisher=U.S. Food and Drug Administration |date=29 March 2012 |accessdate=25 February 2016}}</ref><ref name="ParaviciniBreast15">{{cite web |url=http://www.politico.eu/article/eu-consumer-product-lax-certifiers-of-breast-implant-diesel-engines-notified-bodies/ |title=Breast implant, diesel cases expose lax EU oversight |author=Paravicini, G. |work=Politico |publisher=Politico SPRL |date=11 December 2015 |accessdate=26 February 2016}}</ref> for issues such as:

* "a lack of uniformity in certification procedures and in the application of harmonised standards";<ref name="NoetelConform08" />
* "the varying levels of expertise among notified bodies,"<ref name="ShurenFDA12" /> including "differences in test results";<ref name="NoetelConform08" /> and
* "encouraging 'forum shopping' by sponsors to identify those notified bodies with the most lax operating standards."<ref name="ShurenFDA12" />

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.<ref name="NoetelConform08" /> However, more criticism would arise out of the [[Company:Poly Implant Prothèse|Poly Implant Prothèse]] (PIP) [[Company:Poly Implant Prothèse#Scandal|scandal]] in early 2010, when media revealed that the French manufacturer of silicone gel [[Unsolved:Breast implant|breast implant]]s had been using unapproved in-house manufactured industrial-grade instead of [[Medicine:Medical grade silicone|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."<ref name="ChowdhuryEuro14" /><ref name="LoveFrance11">{{cite web |url=https://www.reuters.com/article/us-breast-implants-idUSTRE7BM14420111224 |title=France, UK issue clashing advice on breast implants |author1=Love, B. |author2=Flynn, D. |work=Reuters |publisher=Thomson Reuters |date=23 December 2011 |accessdate=25 February 2016}}</ref>

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."<ref name="ChowdhuryEuro14" /><ref name="ClementFull10">{{cite web |url=http://www.qmed.com/consultants/full-manufacturer-addresses-medical-device-labels |title=Full Manufacturer Addresses on Medical Device Labels? |author=Clement, R. |work=Consultants Corner |publisher=UBM Canon |date=November 2011 |accessdate=25 February 2016}}</ref> 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|traceability]].<ref name="EisenhartTighter12">{{cite web |url=http://www.emergogroup.com/blog/2012/02/tighter-eu-regulatory-controls-proposed-following-pip-controversy |title=Tighter EU Regulatory Controls Proposed following PIP Controversy |author=Eisenhart, S. |work=Emergo Blog |publisher=Emergo Group |date=13 February 2012 |accessdate=25 February 2016}}</ref> 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.<ref name="EisenhartOver12">{{cite web |url=http://www.emergogroup.com/blog/2012/10/overview-new-medical-device-regulations-europe |title=Overview of new medical device regulations in Europe |author=Eisenhart, S. |work=Emergo Blog |publisher=Emergo Group |date=23 October 2012 |accessdate=25 February 2016}}</ref> 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.<ref name="ChowdhuryEuro14" /><ref name="EisenhartEuro12">{{cite web |url=http://www.emergogroup.com/blog/2012/11/european-commission-plans-greater-oversight-notified-bodies |title=European Commission Plans Greater Oversight of Notified Bodies |author=Eisenhart, S. |work=Emergo Blog |publisher=Emergo Group |date=30 November 2012 |accessdate=25 February 2016}}</ref>

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.<ref name="MontensPIP14">{{cite web |url=http://www.lexology.com/library/detail.aspx?g=28a21496-a3d9-4b05-8a13-fa3027f826c8 |title=PIP breast implants patients obtain a first 5,000,000 Euro victory against the Notified Body TUV Rheinland |author1=Montens, E. |author2=Plasschaert, E. |work=Lexology |publisher=Globe Business Publishing Ltd |date=22 May 2014 |accessdate=25 February 2016}}</ref> 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."<ref name="CarbonnelleMedical15">{{cite web |url=http://www.twobirds.com/en/news/articles/2015/global/life-sciences-newsletter-june/medical-device-liability-update |title=Medical device liability update |author1=Carbonnelle, N. |author2=Martens, M.-P. |author3=Goraya, T. |work=Bird & Bird News Centre |publisher=Bird & Bird |date=2 July 2015 |accessdate=25 February 2016}}</ref> 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.<ref name="CarbonnelleMedical-2_15">{{cite web |url=http://www.lexology.com/library/detail.aspx?g=1219c1ad-910a-4ce3-ae04-bb638f1da089 |title=Medical devices liability update |author1=Carbonnelle, N. |author2=Martens, M.-P. |author3=Thiénot, J.-B. |author4=Goraya, T. |work=Lexology |publisher=Globe Business Publishing Ltd |date=17 November 2015 |accessdate=25 February 2016}}</ref>

{{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."<ref name="Rudd-ClarkeAProd15" />

==Nando database==
The European Union maintains an online database of accredited Notified Bodies.
The {{Official webpage|https://ec.europa.eu/growth/tools-databases/nando/|name=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.

==See also==
* [[Accreditation]]
* Deutsches Institut für Bautechnik

==References==
{{Reflist|33em}}

==External links==
* [http://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies/index_en.htm European Commission portal on notified bodies]
* [https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en European Commission portal on harmonised standards]
* [http://europa.eu/rapid/press-release_IP-14-699_en.htm European Commission 2014 Action Plan]

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[[Category:Accreditation]]

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