Team-NB is a voluntary organization of Medical Device Notified Bodies (doesn’t represent all EU NB’s under the 3 Medical Device Directives) and as of 12 Nov 2012 there are now 35 members.  During the 9 Oct 2012 Assembly in addition to the adoption of the CoC three (3) new members were unanimously added (LGA InterCert GmbH – Nurnberg Deutschland, UDEM – Ankara Turkey, and ALBERK QA TECKNIC – Istanbul Turkey).

The Version 3.0 Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC, & 98/79/EC is a very thorough document which is 31 pages long and includes the Unannounced Inspections (or Unannounced Audits of Medical Device Manufacturers that are Certified under the applicable Medical Directive) which comes from the recently proposed Medical Device Regulations.  As of the 30 October 2012 News Release 14 Notified Bodies had signed the V3.0 CoC and 2 additional NBs (LNE/G-MED & DQS) signed prior to 12 Nov 2012.  It is anticipated that more NBs will sign in the near future as they adopt the policies covered within the V3.0 CoC which shows their commitment to improve the implementation of the EU CE marking certification of medical devices through clarified organizational criteria, management of competence and assessment practices.  The major topics in the document are:

• Implementation, enforcement and monitoring of the Code of Conduct
• Qualification and Assignment of Notified Body Assessment Personnel
• Minimum time for Notified Body assessments
• Unannounced visits
• Sampling of class IIa and IIb technical files
• Design Dossier Reviews
• Rules for subcontracting
• Rules for Certification Decisions 

Further revisions will be made to be in line with the new developments of the European legislation.

The following text has been taken straight from the Health Canada website on the page for this final guidance document

“A draft version of this guidance document was first published and released for consultation in 2006. Comments from stakeholders and the Scientific Advisory Panel on Reprocessing of Medical Devices have been considered in producing this final version.

To reduce the risks associated with the use of reprocessed reusable medical devices, Health Canada has developed this guidance document to aid manufacturers of Class I, II, III and IV reusable medical devices in the preparation of reprocessing and sterilization information to be provided with these devices.

The guidance document is intended to assist manufacturers in understanding and complying with the regulatory requirements of section 21(1)(i) of the Medical Devices Regulations as they pertain to the directions for use for reusable medical devices. This guidance document should be used in conjunction with the Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations.

In order to provide industry with sufficient time to meet the specifications of the guidance document, Health Canada will allow a six-month transition period commencing on the date of implementation, June 1, 2011. Following the transition period, Health Canada will expect manufacturers to meet the specifications listed in the guidance document.

Further information on this guidance document, and a summary of comments received and Health Canada’s responses to them, may be obtained by contacting:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Phone: 613-954-0297
Fax: 613-957-9969
E-mail: DED_manager@hc-sc.gc.ca

Published by authority of the Minister of Health

Date Adopted 2011/06/01

Effective Date 2011/06/01

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.”