Organisation for Certification and Testing on the Field of Medical and Hospital Engineering / CMK-M-03
Number of edition: 01
Number ofversion: 08
Valid from: 20.02.2018
REQUEST FORM FOR CE CONFORMITY ASSESSMENT
(1) Data of the manufacturer
Name of the manufacturer:
Headquarters:
Phone: / Fax:
E-mail: / Web:
Name of official representative: / Position:
Data of the authorised representative (in case of a manufacturer outside of EEA)
Name: / Address:
Phone: / E-mail:
File name: CMK-M-03 Request form v08_en / Page / Number of pages: 1 / 3
/ CE Certiso Ltd.,
Organisation for Certification and Testing on the Field of Medical and Hospital Engineering / CMK-M-03
Number of edition: 01
Number ofversion: 08
Valid from: 20.02.2018
REQUEST FORM FOR CE CONFORMITY ASSESSMENT
Data of contact person
Name: / Position:
Phone: / E-mail:
(2) Necessary information for price offer
Certification route (only one route for one offer):
(In case you need a design examination please fill in request form CMK-M-03gy as well!)
Directive 93/42/EEC on Medical devices, Annex II excluding (4), full quality assurance system
Directive 93/42/EEC on Medical devices, Annex V, production quality assurance
Directive 93/42/EEC on Medical devices, Annex VI, product quality assurance
Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD), Annex 2 excluding (4), full quality assurance system
Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD), Annex 5, production quality assurance
[in case of a device certified according to Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD), Annex 3]
Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex IV excluding (4, 6), full quality assurance system
Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex VII, production quality assurance
[in case of a device certified according to Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex V]
Scope (this will be on the certificate):
Product range:
Name of device* / Type / Intended use / Model / Risk class / NBOG code / GMDN category
Product codes / Special codes
*In case of new or not generally known products, please enclose detailed product specification, product brochure or instructions for use, or access to them.
Number of technical files:
Data of the related technical files:
Technical file ID / Related product types / models
Applied technologies:
Critical subcontracted processes:
Data of critical subcontractors:
Name / Address: / Activity:
Statistical number of employees concerned in the area of the certification:
Number of sites:
Fill out for each site:
Name and address of site: / Product range: / Applied technologies: / Statistical number of employees concerned in the area of the certification:
Headquarters/
Site 1
Site 2
Site 3
Language of the audit: / Language of documentation: / Requested deadline
of the offer:
Number and language of requested certificates:
(3) Other information
Do you have a system certified according to one of the following?
Certification standard: / EN ISO 9001:2015 / EN ISO 13485:2016
MDD Annex / AIMD Annex / IVDD Annex
You wish to perform a change of notified body
Any other information, remark or request concerning the offer:
Please, prepare us a quotation for certification based on the data amplified in this document.
Date: / Signature:Signatory:
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Please, send back this request form to one of these addresses:
E-mail:
Fax: +36 23 880 831
Postal address: 2040 Budaörs, Gyár u. 2., Hungary
CE Certiso Ltd. reserves the right to call for additional data.
File name: CMK-M-03 Request form v08_en / Page / Number of pages: 1 / 3