Use of certificates, logos and CE mark
of conformity
General
Certificates & logos
with respect to voluntary certification systems (ISO 9000; EN 46000) may be used for
marketing purposes
The CE mark is a legal mark
of product conformity with an European directive
Personnel shall be trained
in the significance of the proper use of such certificates, logos and the CE mark
Misuse of either may lead to
legal measures or measures by the Certification Body
ISO 9001/2/3, EN
46001/2 and ISO 13485/88 logos
The logos with respect to
the voluntary QM certifications maybe used on letterheads and other marketing means but
shall include a written reference to the certified QM system. The logo shall not be used
on products and labels or in a way that may be interpreted as denoting product conformity.
An electronic and hard copy of mdc and partner logos, including reference to certfied
standards, can be obtained on request. If questions of proper use of logos remain mdc
should be contacted.
CE mark of conformity
The CE mark is applied in
accordance with the requirements, as stipulated, in the Medical Device Directive 93/42/EEC
Article 17 & Annex XII.
The CE mark is configured with
the mdc Notified Body number, for example, as shown:
The Notified Body number is
used with the CE mark when the Notified Body has been involved in the certification
process (i.e. all product types except the Class I (non-sterile and without measuring
function). Additional words/descriptions shall not be used together with the CE printing.
The CE mark is used on labels, boxes, products and instructions for use. It shall not be
used on letter heads. An electronic copy of the above indicated marking with number can be
obtained on request from mdc. The CE mark may only be applied in conjunction with a valid
certificate in accordance with the Medical Device Directive MDD 93/42/EEC.
Further Information:
Publicizing your ISO 9000
or ISO 14000 certification. ISO publication. Available free of charge on request from the
ISO Central Secretariat, Case postale 56, CH-1211 Geneva 20, Switzerland; ph. +41 22 749
01 11; fax: +41 22 733 34 30; e-mail: iso9000@iso.ch; webpage: http://www.iso.ch/
ISO/IEC Guide 23: Methods of
indicating conformity with standards for third-party certification systems. ISO/IEC
publication.
The aforementioned information can be downloaded
in portable document format (pdf) as follows: Use of certificates, logo and CE mark of
conformity (110 KB)
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