Improving the Performance of Notified Bodies
With encouragement from the EC Commission a ‘Code of Conduct for Notified Bodies’ has been written and recently signed by an initial group of 11 Notified Bodies, including SGS United Kingdom Limited as Notified Body 0120. The Code of Conduct will be independently audited to ensure compliance.
Code of Conduct for Notified Bodies
This first issue covers: Qualification and assignment of auditors and technical file reviewers; a standard method for calculation of audit times and technical file review times; how to sample technical files for Class IIa and IIb devices; the depth of review for class IIa, IIb and III technical documentation; subcontracting; what expertise must be in house and; competence of the certification decision maker.
Objective of the Code of Conduct
The objective of the Code of Conduct is not to stop competition and efficiency improvements but to highlight and then stop the practice where most bodies would require five days for an audit but one body decides they only need two days; or where a Notified Body uses a technical file reviewer with no experience of the device or its use.
Increased confidence in certification
Certification at a level below that which can provide confidence risks devaluing the certification and approval of the vast majority of manufacturers who wish to achieve true compliance and a safe and performing product.
Code of Conduct available via SGS website
As the Code of Conduct is based on current best practice of the leading Notified Bodies customers of certification bodies such as SGS, should not see significant differences in operation. A joint Press Release has been published. Future editions of the SGS Medical Devices Newsletter will contain further articles on this subject.
For a copy of the Code of Practice, please request one from SGS via email.
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Medical Device Team
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 67,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.