CE Mark

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 EU 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; alternatively, a notified body 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 essential requirements of 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 type examination certificate, (and ensuring the product also satisfies all other applicable regulations), the manufacturer can generate its declaration of conformity and label the product with the CE Mark, which is required for distribution and sale in the EU. Additionally, the EU member state accrediting the notified body will then inform the European Commission that the product complies with the essential requirements (or not).[1][2][3]

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 regulations, but also to provide an official certification mark or a declaration of conformity.[4][5]

Criticism and improvement

The notified bodies system used by the European Union has been publicly criticized in some capacity since at least 2008[6][7][8][9][10] for issues such as:

  • "a lack of uniformity in certification procedures and in the application of harmonised standards";[6]
  • "the varying levels of expertise among notified bodies,"[9] including "differences in test results";[6] and
  • "encouraging 'forum shopping' by sponsors to identify those notified bodies with the most lax operating standards."[9]

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.[6] 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."[7][11]

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."[7][12] 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.[13] 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.[14] 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.[7][15]

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.[16] 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."[17] 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.[18]

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."[3]

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

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 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.

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.[19][2]

See also

References

  1. ↑ The 'Blue Guide' on the Implementation of EU Product Rules (PDF) (1.1 ed.). European Commission. 15 July 2015. p. 134. Retrieved 25 February 2016.
  2. 1 2 "Notified bodies". Growth: Internal Market, Industry, Entrepreneurship and SMEs. European Commission. 11 February 2016. Retrieved 25 February 2016.
  3. 1 2 Rudd-Clarke, P.; Page, F. (9 December 2015). "A product of our times". Insider Quarterly (Winter 2015). Archived from the original on 25 February 2016. Retrieved 25 February 2016.
  4. ↑ Medicines and Healthcare Products Regulatory Agency (November 2013). "Guidance on Legislation: Requirements for UK Notified Bodies" (PDF). Government of the U.K. p. 14. Retrieved 25 February 2016.
  5. ↑ Standards Office of the General Cooperation Council for the Arab States of the Gulf (26 November 2008). "Guide for Notified Bodies" (PDF). GCC Standardization Organization - GSO. p. 12. Archived from the original (PDF) on 1 April 2015. Retrieved 25 February 2016.
  6. 1 2 3 4 Noetel, K.-H. (11 September 2008). "Conformity assessment and notified bodies" (PDF). European Conference on Standardization, Testing and Certification. Retrieved 25 February 2016.
  7. 1 2 3 4 Chowdhury, N. (2014). "Chapter 6: Case Study on Medical Devices Regulation in Europe". European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty. Cham, Switzerland: Springer International Publishing Switzerland. pp. 99–120. ISBN 9783319045948. Retrieved 25 February 2016.
  8. ↑ Maxwell, A. (30 November 2009). "Tightening oversight of notified bodies: Enough to satisfy critics?". Clinica. Informa PLC. Retrieved 25 February 2016.
  9. 1 2 3 Shuren, J. (29 March 2012). "FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients (JS)". Testimony. U.S. Food and Drug Administration. Retrieved 25 February 2016.
  10. ↑ Paravicini, G. (11 December 2015). "Breast implant, diesel cases expose lax EU oversight". Politico. Politico SPRL. Retrieved 26 February 2016.
  11. ↑ Love, B.; Flynn, D. (23 December 2011). "France, UK issue clashing advice on breast implants". Reuters. Thomson Reuters. Retrieved 25 February 2016.
  12. ↑ Clement, R. (November 2011). "Full Manufacturer Addresses on Medical Device Labels?". Consultants Corner. UBM Canon. Retrieved 25 February 2016.
  13. ↑ Eisenhart, S. (13 February 2012). "Tighter EU Regulatory Controls Proposed following PIP Controversy". Emergo Blog. Emergo Group. Retrieved 25 February 2016.
  14. ↑ Eisenhart, S. (23 October 2012). "Overview of new medical device regulations in Europe". Emergo Blog. Emergo Group. Retrieved 25 February 2016.
  15. ↑ Eisenhart, S. (30 November 2012). "European Commission Plans Greater Oversight of Notified Bodies". Emergo Blog. Emergo Group. Retrieved 25 February 2016.
  16. ↑ Montens, E.; Plasschaert, E. (22 May 2014). "PIP breast implants patients obtain a first 5,000,000 Euro victory against the Notified Body TUV Rheinland". Lexology. Globe Business Publishing Ltd. Retrieved 25 February 2016.
  17. ↑ Carbonnelle, N.; Martens, M.-P.; Goraya, T. (2 July 2015). "Medical device liability update". Bird & Bird News Centre. Bird & Bird. Retrieved 25 February 2016.
  18. ↑ Carbonnelle, N.; Martens, M.-P.; Thiénot, J.-B.; Goraya, T. (17 November 2015). "Medical devices liability update". Lexology. Globe Business Publishing Ltd. Retrieved 25 February 2016.
  19. ↑ "EUROPA - European Commission - Growth - Regulatory policy - NANDO".
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