128:. 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.
17:
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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
164:
identification number and contact details of each notified body as well as the tasks for which it has been notified. The lists as well as the designated tasks for each notified body are subject to regular update: as the notification of notified bodies (and their withdrawal, suspension, reinstatement) is the responsibility of the notifying EU Member State (and not of the
European Commission), the data in this Nando database is provided by the designating authorities of that EU Member States.
140:(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.
135:
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
72:
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 regulations, but also to provide an official certification mark or
143:
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
167:
The database can be used to verify the status (valid/withdrawn/expired/suspended) of a notified body related to a particular
European Directive or Regulation as well as the associated designated scope of tasks related to conformity assessment procedures set out in that Directive or Regulation....
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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
95:
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 EU member states. However, more criticism would arise out of the
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The
European Commission maintains an online database which includes all designated notified bodies: Nando (New Approach Notified and Designated Organisations) Information System. This searchable and publicly available Nando database contains different lists of notified bodies, including the
53:(MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices. With this type examination certificate, (and ensuring the product also satisfies all other applicable regulations), the manufacturer can generate its
40:
A manufacturer can use voluntarily
European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; alternatively, a notified body assess the conformity to these essential requirements.
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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."
36:
to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in
European directives or regulations.
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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
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to have a detrimental impact on the cost for manufacturers of getting a product to market, while notified bodies may face a significantly increased
61:, which is required for distribution and sale in the EU. Additionally, the EU member state accrediting the notified body will then inform the
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The notified bodies system used by the
European Union has been publicly criticized in some capacity since at least 2008 for issues such as:
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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
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Regulations governing medical device manufacturers and Notified Bodies operating in the medical device field were tightened with the
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In late 2013 and early 2014, a French court ordered (and later upheld its decision) that notified body TÜV Rheinland pay
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91:"encouraging 'forum shopping' by sponsors to identify those notified bodies with the most lax operating standards."
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460:"FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients (JS)"
649:"PIP breast implants patients obtain a first 5,000,000 Euro victory against the Notified Body TUV Rheinland"
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Standards Office of the General Cooperation Council for the Arab States of the Gulf (26 November 2008).
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More generally, a notified body is an independent, accredited body which is entitled by an authorized
396:
European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty
88:"the varying levels of expertise among notified bodies," including "differences in test results"; and
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85:"a lack of uniformity in certification procedures and in the application of harmonised standards";
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398:. Cham, Switzerland: Springer International Publishing Switzerland. pp. 99–120.
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for most of its implants. Investigators also brought criticism down on notified body
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Carbonnelle, N.; Martens, M.-P.; Thiénot, J.-B.; Goraya, T. (17 November 2015).
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had been using unapproved in-house manufactured industrial-grade instead of
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105:
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673:
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428:"Tightening oversight of notified bodies: Enough to satisfy critics?"
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Medicines and Healthcare Products Regulatory Agency (November 2013).
324:. GCC Standardization Organization - GSO. p. 12. Archived from
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that the product complies with the essential requirements (or not).
729:"EUROPA - European Commission - Growth - Regulatory policy - NANDO"
568:"Tighter EU Regulatory Controls Proposed following PIP Controversy"
364:. European Conference on Standardization, Testing and Certification
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in early 2010, when media revealed that the French manufacturer of
58:
622:"European Commission Plans Greater Oversight of Notified Bodies"
392:"Chapter 6: Case Study on Medical Devices Regulation in Europe"
293:"Guidance on Legislation: Requirements for UK Notified Bodies"
209:(1.1 ed.). European Commission. 15 July 2015. p. 134
236:
Growth: Internal Market, Industry, Entrepreneurship and SMEs
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Carbonnelle, N.; Martens, M.-P.; Goraya, T. (2 July 2015).
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The 'Blue Guide' on the Implementation of EU Product Rules
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541:"Full Manufacturer Addresses on Medical Device Labels?"
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595:"Overview of new medical device regulations in Europe"
487:"Breast implant, diesel cases expose lax EU oversight"
514:"France, UK issue clashing advice on breast implants"
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32:, is an organisation that has been designated by a
750:European Commission portal on harmonised standards
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148:risk for failure to comply with their duties."
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49:conforms to the essential requirements of the
745:European Commission portal on notified bodies
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260:Rudd-Clarke, P.; Page, F. (9 December 2015).
647:Montens, E.; Plasschaert, E. (22 May 2014).
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359:"Conformity assessment and notified bodies"
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512:Love, B.; Flynn, D. (23 December 2011).
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238:. European Commission. 11 February 2016
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138:Court of Justice of the European Union
755:European Commission 2014 Action Plan
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485:Paravicini, G. (11 December 2015).
466:. U.S. Food and Drug Administration
357:Noetel, K.-H. (11 September 2008).
298:. Government of the U.K. p. 14
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703:"Medical devices liability update"
620:Eisenhart, S. (30 November 2012).
566:Eisenhart, S. (13 February 2012).
14:
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676:"Medical device liability update"
593:Eisenhart, S. (23 October 2012).
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183:Deutsches Institut für Bautechnik
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784:Regulation in the European Union
426:Maxwell, A. (30 November 2009).
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709:. Globe Business Publishing Ltd
655:. Globe Business Publishing Ltd
57:and label the product with the
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794:Regulation of medical devices
539:Clement, R. (November 2011).
268:(Winter 2015). Archived from
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73:a declaration of conformity.
458:Shuren, J. (29 March 2012).
7:
680:Bird & Bird News Centre
319:"Guide for Notified Bodies"
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10:
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51:Medical Devices Regulation
153:Medical Device Regulation
77:Criticism and improvement
55:declaration of conformity
262:"A product of our times"
390:Chowdhury, N. (2014).
113:medical-grade silicone
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789:Product certification
98:Poly Implant Prothèse
43:Conformity assessment
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272:on 25 February 2016
63:European Commission
545:Consultants Corner
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682:. Bird & Bird
520:. Thomson Reuters
266:Insider Quarterly
232:"Notified bodies"
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106:silicone gel
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713:25 February
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547:. UBM Canon
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133:restitution
70:accrediting
773:Categories
189:References
146:litigation
464:Testimony
155:of 2017.
28:, in the
707:Lexology
653:Lexology
491:Politico
172:See also
518:Reuters
432:Clinica
102:scandal
59:CE Mark
20:CE Mark
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100:(PIP)
762:Nando
362:(PDF)
329:(PDF)
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Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
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