/ QS ZÜRICH AG
PO. Box 6335- CH 8050Zürich
+41 (0)443504665
/ Questionnaire for Quotation 93/42/EEC

Many thanks for your interest in our service. If you need any assistance in completing this form please call +41 (0)61 722 04 24 or mail to

1. Applicant
Company name:
Address:
Contact / Tel:
Email:: / Website:
Industry / activities / MD scope:

Please enclose your company brochure.

2. Details about your quality management system
departments
Please specify the (approximate) number of (full and part-time) employees in the particular departments / Quality management / Research and development / Purchasing / Production / Storage / Marketing and sales / Administration / Others:…………… / Summary / Number of shift workers
Name and address of the head quarter, as well as of the possible subsidiaries/branches, that will be included in the certification.

Please enclose an organization chart of your headquarter as well as of the possible subsidiaries/branches.

Process / Name and place of companiesto which relevant activities were outsourced(suppliers and/or subcontractors).
Research and development
Production
Packaging
Sterilization
Storage
Services
Others
Name and place of your Commercial CompetitorsPlease list your commercial competitors (so we can ensure our independence and impartiality).
Do you desire a pre audit (Recommended in case of certification for the first time)? / yesno
In what language can the audit be carried out? / German / English / ……………………….
In what language is your QM system written? / German / English / ……………………….
In what language is your technical documentation written? / German / English / ……………………….
3. Details about the Medical Device, for which a certification according to dir. 93/42/ECC is intended
Tradename / MD scope [NBOG BPG 2009-3 for all devices] / Class / Rule[CLASSIFICATION CRITERIA] / Description of the device or device category
GMDN code required for class IIb/III devices / Intended use

Please add detailed product information / brochures / user manuals.

3.1 Number of technical documentations
Document name(product, productgroup) / Number of pages
1.
2.
3.
4.

3.2.a Additional details about the product or device categories that are mentioned under point 3

Is the device equipped with an external or internal energy source? / yesno
Doesthe device include software? / yesno
Is the device equipped with a measuring function? / yesno
In case of an active device, is an EMC test report of an accredited test laboratory available? / yesno
Does the device incorporatehuman blood derivative? / yesno
Is the device manufacturedutilising tissues of animal origin? / yesno
Does the device contain any medicinal products? / yesno
Is a biocompatibility test of an accredited test laboratory available? / yesno
Is a risk analysis available? / yesno
Does the device require sterilization prior to being used? / yesno
Does the product contain latex material as an integral part or is latex used as an excipient during production? / yesno
Do you sell products under your company name, which are certified by other companies? / yesno
If yes, did the original equipment manufacturer (OEM) already carry out a conformity assessment procedure? / yesno
Have the devices described in Chapter 3 already been certified? / yesno

Please enclose copies of already existing certificates of conformity according to dir. 93/42/EEC.

3.2.bDetail about processing Agent

1 -Enlist all ID’s/brand name/constituent material of cleaning Agent / anti sticking, greasing and oiling Agent that are used in the product and come into contact directly or indirectly to the product
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2 – Enlist utilities that come in to contact with the product during process (ex. Compressed air, Nitrogen water, etc.)
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3.3 Details about sterile products and other aspects

Are the products or device categories mentioned under point 3 produced or handled under sterile conditions? / yes no
If yes, what methods are applied for sterilization? / ethylene oxide accordingto ISO 11135-1
irradiation according toISO 11137-1
moist heat according toISO 17665-1
Others: ……………………
Is the sterilisation processvalidated for the specified products? / yesno
Does the product used for immune-compromised patient (pediatric pregnant) / yesno
Does the product or raw material contain DEHP? / yesno
3.4Quality management system (QMS)
Does your company operate a QMS? / yesno
If yes, which guidelines and/or standards do you apply? / EN ISO 9001
EN ISO 13485
GMP
………………..
When wasQMSintroduced (month/year)? / ………………………….
Is your QMS already certified? / yesno
Date of the last (internal) audit / ………………………….
Results of the last (internal) audit
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Please add copies of your quality management system certificates in case your quality management system is already certified.

4 Time scheduling

Please specify the scheduleddates for technical documentation assessment: / ……………………………………
Do you request QMS certification by QS Zürich AG? / yesno
Please specify the scheduleddates for the audit / ……………………………………

Declaration:

I hereby declare that all above information is correct.

Date:Signature:Stamp:

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5Check by QS Zürich

Information supplied by the applicant is sufficient for preparing the quotation

Date:Signature:

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CLASSIFICATION RULES

Excerpt from [Directive 93/42 EEC ANNEX IX]:

Rule 1
All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.
Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa,
•if they may be connected to an active medical device in Class IIa or a higher class;
•if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues;
in all other cases they are in Class I.
Rule 3
All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class llb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa.
Rule 4
All non-invasive devices which come into contact with injured skin,
•are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
•are in Class Ilb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent;
•are in Class Ila in all other cases, including devices principally intended to manage the micro-environment of a wound.
Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device
•are in Class I if they are intended for transient use;
•are in Class lla if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I;
•are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class lla or a higher class, are in Class IIa.
Rule 6
All surgically invasive devices intended for transient use are in Class lIa unless they are,
•intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
•reusable surgical instruments, in which case they are in Class I;
•intended to supply energy in the form of ionizing radiation in which case they are in Class llb;
•intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb;
•intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which they are in Class lIb.
Rule 7
All surgically invasive devices intended for short-term use are in Class IIa unless they are intended,
•either specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III;
•or specifically for use in direct contact with the central nervous system, in which case they are in Class III;
•or to supply energy in the form of ionizing radiation in which case they are in Class IIb;
•or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III;
•or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class lIb.
Rule 8
All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended,
•to be placed in the teeth, in which case they are in Class Ila;
•to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class Ill;
•to have a biological effect or to be wholly or mainly absorbed, in which case they are in ClassIll;
•or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III.
Rule 9
All active therapeutic devices intended to administer or exchange energy are in Class lIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which cast they are in Class lIb.
All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class llb.
Rule 10
Active devices intended for diagnosis are in Class IIa,
•if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum;
•if they are intended to image in vivo distribution of radiopharmaceuticals;
•if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.
Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class lIb.
Rule 11
All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class lIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb.
Rule 12
All other active devices are in Class I.
Rule 13
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 65/65/EEC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class Ill.
Rule 14
All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class lIb, unless they are implantable or long term invasive devices, in which case they are in Class III.
Rule 15
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb. All devices intended specifically to be used for disinfecting medical devices are in Class IIa. This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.
Rule 16
Non-active devices specifically intended for recording of X-ray diagnostic images are in Class Ila.
Rule 17
All devices manufactured utilising animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only.
Rule 18
By derogation from other rules, blood bags are in Class Ilb.

Please send the completed questionnaire to:

/ or / QS Zürich AG
Erlenstrasse 31
CH-4106 Therwil

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