APPLICATION FOR CERTIFICATION OF MEDICAL DEVICES 1/14

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1 1/14 In order for us to prepare a quotation and send you a certification contract, please fill in this application form and return it to: LNE/G-MED 1 rue Gaston Boissier Paris Cedex 15 France For company located in USA, Canada and Mexique, you may return the questionnaire to: G-MED North America, Inc Georgia Avenue Silver Spring MD USA I. GENERAL INFORMATION ABOUT THE COMPANY APPLYING FOR CERTIFICATION Company name:... Address:... Tel.:... Fax: Legal status:... Company identification number in your country:... (or VAT number for European companies) NACE code:... Name of contact person:... Position held:... Address:... Tel.:... Fax: Chief executive (person authorized to sign the certification contract between LNE/G-MED and the company): If the manufacturer is not located in the European Economic Area: Name of representative:... Address:... Name of contact person:... Tel.:... Fax:

2 2/14 Site(s) to be covered by the certification Name of site Address Main activity or activities Number of staff Are all sites operated under a single quality system? Yes No Please state which quality systems are operated and which sites they cover: Do you wish all sites to be covered by one quality system certificate only? Yes No Please state how many certificates are required and which sites each certificate is to cover: Are the following processes implemented (internally or subcontracted)? Sterilization Yes No Cleaning Yes No Packaging Yes No Date of last validation (or revalidation) of sterilization process: Date of last validation (or revalidation) of cleaning process: Date of last validation (or revalidation) of packaging process:

3 3/14 II. MEDICAL DEVICES TO BE COVERED BY CERTIFICATION Fill in this section if you are applying for certification for CE marking or certification according to Canadian regulations. Please enclose the instructions for use for each device, or other documents explaining the intended use. II.1. Medical devices for which CE marking is required (European regulations) Section not applicable (tick this box if the purpose of your application is not to meet European requirements concerning medical devices) Medical device (short description) State if device is sterile, if it has a measuring function, if it incorporates medication, if it utilizes tissue of animal origin, or if a biological product of animal origin is used in the manufacturing process. 1 Sterilization If device is sterile, specify sterilization method: EtO / Irradiation / Moist heat / other Brand name Class according to Annex IX of Directive 93/42/EEC or Annex II of Directive 98/79/EC, or self-testing device GMDN code (Global Medical Device Nomenclature) ISO/TS 20225: Enclose separate list with requested data if necessary. 2 Canadian PNC code, American SPN, or French code [AFNOR FD CR (2002), indice de classement S ].

4 4/14 II.2. Medical devices intended for the Canadian market (Canadian regulations) Section not applicable (tick this box if the purpose of your application is not to meet Canadian requirements concerning medical devices) Medical device (short description) State if device is sterile, if it has a measuring function, if it incorporates medication, if it utilizes tissue of animal origin, or if a biological product of animal origin is used in the manufacturing process. 1 Sterilization If device is sterile, specify sterilization method: EtO / Irradiation / Moist heat / other Brand name Class according to Article 6 of Canada s Medical Devices Regulations (MDR) GMDN code (Global Medical Device Nomenclature) ISO/TS 20225: Licence number (if applicable) 1 Enclose separate list with requested data if necessary. 2 Canadian PNC code, American SPN, or French code [AFNOR FD CR (2002), indice de classement S ]. Note: The medical device categories stated on the quality system certificate must correspond to the categories declared on the licence applications submitted to Health Canada. Health Canada will not accept separate quality system certificates for each component or product in a line of medical devices. The applicant for quality system certification (company name and address) must be the declared manufacturer, or must be stated as such in the application for a Canadian licence.

5 5/14 II.3. Medical devices placed on the market according to Own Brand Labelling procedure (OBL) Criteria for applying the OBL procedure: The medical device covered by the CE marking application already has CE marking certification obtained by your subcontractor in his own name. The product must be placed on the market in your own name, ie. you are the manufacturer within the meaning of the European Directives. You act as distributor only and perform no packaging/repackaging or labelling/relabelling functions. This procedure does not apply to applications for certification according to Annex IV of Directives 93/42/EEC or 90/385/EEC or Annex VI of Directive 98/79/EC. An OBL procedure must not have been used for the CE marking certification obtained for the medical device by your subcontractor. Medical device (short description) State if device is sterile, if it has a measuring function, if it incorporates medication, or if it utilizes tissue of animal origin. 1 Brand name Class Actual manufacturer of device Details of manufacturer s CE marking certificates GMDN code (Global Medical Device Nomenclature) ISO/TS 20225: Enclose separate list with requested data if necessary. 2 Canadian PNC code, American SPN, or French code [AFNOR FD CR (2002), indice de classement S ].

6 6/14 III. ACTIVITY COVERED BY THE QUALITY SYSTEM (Voluntary certification according to ISO or EN standards only) Please give draft title(s) of certificate(s). In English:... In French (if available):... LNE/G-MED certificates are drawn up in both English and French. If you require LNE/G-MED to issue certificates in another language, please specify:... Requests for other languages are examined individually. Please contact LNE/G-MED for further information.

7 7/14 IV. STANDARDS REQUIRED FOR LNE/G-MED CERTIFICATION IV.1. Voluntary certification (Fill in section III). ISO 9001 (2000) - Quality management system ISO (2003) - Medical devices - Quality management system - Requirements for regulatory purposes NF EN ISO (2004) - Medical devices - Quality management system - Requirements for regulatory purposes EN 550 (1994) - Sterilization of medical devices with ethylene oxide EN 552 (1994) - Sterilization of medical devices by irradiation EN 554 (1994) - Sterilization of medical devices by moist heat Certification according to Canadian Medical Devices Regulations [art. 32 (2) f - 32 (3) j - 32 (4) p] Fill in sections II.2 and III. ISO (2003) Note: The manufacturer specified in the licence application submitted to Health Canada must have ISO certification. If the legal manufacturer within the meaning of the Canadian regulations is not the company specified in section I of this application form, another form must be completed in the name of the legal manufacturer specified in the licence application. IV.2. Certification of medical devices (except in vitro diagnostic devices) for CE marking Directive 90/385/EEC covering active implantable medical devices Directive 93/42/EEC covering medical devices The choice of conformity assessment procedure depends on the class of the device. See CE marking procedures in annex 1. NB: If the annexes chosen are not the same for all the devices listed in section II.1, please indicate which annex applies to which device(s) on a separate sheet. Annexes II.3 - EC declaration of conformity: "full quality assurance system without examination of product design" II.4 - EC declaration of conformity: "examination of product design" III - EC type examination IV - EC verification V - EC declaration of conformity: "production quality assurance" VI - EC declaration of conformity: "product quality assurance" Choice of annex limited to securing and maintaining sterile state Choice of annex limited to control of measuring function

8 8/14 IV.3. Certification of in vitro diagnostic medical devices for CE marking Directive 98/79/EC covering in vitro diagnostic medical devices The choice of conformity assessment procedure depends on the product listing in Article 9 of the Directive. See CE marking procedures in annex 2. NB: If the annexes chosen are not the same for all the devices listed in section II.1, please indicate which annex applies to which device(s) on a separate sheet. Annexes III.6 - EC declaration of conformity: "examination of product design for devices for self-testing" IV.3 - EC declaration of conformity: "full quality assurance system without examination of product design" IV.4 - EC declaration of conformity: "examination of product design" IV.3 and IV.6 - EC declaration of conformity: "verification of manufactured products covered by Annex II, List A" V - EC type examination VI - EC verification VII - EC declaration of conformity: "production quality assurance" VII and VII.5 - EC declaration of conformity: "verification of manufactured products covered by Annex II, List A" IV.4. Certification according to Taiwanese regulations Do you require a cover letter in the context of Taiwan s Technical Cooperation Programme on Exchange of Medical Device GMP and ISO Audit Reports? The audit will be performed by a team of specially trained auditors. The audit report will be drawn up in English. NOTE : This service is reserved for companies located on the territory of one the European Union member state. Yes No

9 9/14 V. SUBCONTRACTED ACTIVITIES OR PROCESSES If any activities are subcontracted, eg. design, manufacturing, sterilization, packaging or labelling, please give details below. A LNE/G-MED requires information on each subcontractor s quality system (ISO 13485, EN 550, EN 552, EN 554, etc.) to draw up its proposal. M Name of subcontractor Address Nature of subcontracting Quality system certification Yes 1 No 2 Cleaning 3 Packaging 3 Sterilization 3 Sterilization 3 Storage 3 1 Please enclose a copy of the certificate. 2 If a subcontractor does not have a quality system certificate, please specify the measures taken to control the quality of the services supplied (eg. product specifications, contracts, definition of process requirements, acceptance inspection and tests, subcontractor audit, etc.). 3 This line must be completed if applicable.

10 10/14 VI. INFORMATION CONCERNING YOUR COMPANY AND ITS QUALITY SYSTEM Please send us a company brochure and an organization chart presenting the functions in your company. Have you obtained quality system certificates and/or CE marking certificates before? Yes If yes, please enclose a copy of the certificate(s). No Existing quality documents: Quality manual: Yes No Procedures: Yes No Requirement exclusions envisaged (standards ISO 9001:2000, ISO 13485:2003 and EN ISO 13485:2004): The requirements of clause 7.3 of ISO (or EN ISO 13485) may be excluded only if permitted under the regulations (see foreword and clause 1.2 of ISO 13485). In all other cases the company must justify exclusion of a requirement (see clause 4.2.2a of ISO 9001 and ISO 13485). Specify the clause(s) or subclause(s) excluded from the quality management system: Justification of exclusions:? provided for in the regulations (ISO 13485:2003 or EN ISO 13485:2004)? other justification (essential for ISO 9001:2000): Has your company sought advice or assistance in setting up the quality management system within the last three years? Yes If yes, specify which body provided the service: No Language to be used for the audit: English French Note for companies which use neither English nor French: Whichever language is used at the site(s) to be audited, the following documents must be made available in either English or French: - Quality documents (quality manual, to be provided for preparation of the audit, at least one month in description of processes): advance - Description of medical devices: to be provided with this application form - Validation reports for special processes: to be provided for the audit - EC type examination file or design to be provided for the audit or sent to LNE/G-MED, according to examination file: the annex chosen by the manufacturer During the audit, descriptions of the procedures must be available in English or French, otherwise an interpreter must attend the audit. Details concerning your activity (where applicable): Working hours of office staff:... Working hours of manufacturing staff:... Shift work: Yes No Transit time between the various buildings and/or sites:...

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12 12/14 VII. OTHER RELEVANT INFORMATION Required deadline for certification audit: Date:... Signature of company representative: Useful websites: F LNE/G-MED: F Directives: If you require any further information, please contact our sales engineer: Bruno Treni Tel.: +33 (0) Fax: +33 (0) bruno.treni@lne.fr

13 13/14 ANNEX 1 STATUTORY CERTIFICATION Choice of annex according to class European Directive 93/42/EEC Class I for non-sterile devices and devices with no measuring function Annex VII Class I for sterile devices Annex VII and Annex V (limited to aspects of the manufacturing process designed to secure and maintain a sterile condition) Class I for devices with one or more measuring functions Annex VII and Annex IV or Annex V or Annex VI (limited to aspects of manufacture concerning conformity with metrological requirements) Class IIa or Annex II.3 Annex VII and Annex IV or Annex V or Annex VI Class IIb or Annex II.3 Annex III and Annex IV or Annex V or Annex VI Class III and active implantable medical devices or Annex II.3 and II.4 Annex III and Annex IV or Annex V

14 14/14 ANNEX 2 STATUTORY CERTIFICATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES Choice of annex European Directive 98/79/EC Devices included in list A (Annex II) or Annex IV.3 and IV.4 and IV.6 Annex V and Annex VII.3 and VII.5 Devices included in list B (Annex II) or Annex IV.3 Annex V and Annex VI or Annex VII.3 Devices for self-testing (other than those included in Annex II lists) or or Annex III and III.6 Idem list A Idem list B Other devices Annex III