General framework agreement on performing

conformity assessment of medical devices

Article I

Parties to the agreement

1. INSTITUT PRO TESTOVÁNÍ A CERTIFIKACI, a. s.

(Institute for Testing and Certification, joint stock company),

having its seat in: T. Bati 299, 764 21 Zlín, Czech Republic,

banking with: Komercni banka, a. s., Praha, branch at Zlín,

Account No.: 86211333026710100

IBAN No: CZ8801000000862113330267

SWIFT Code: KOMBCZPP

having company's registration number: 47910381

and company's tax registration number: CZ47910381

person responsible for the matter of Agreement: PhDr. Martin Jankovec,

person responsible for the technical matters: Ing. Pavel Vaněk,

represented by: RNDr. Radomír Čevelík, Director General,

(Hereinafter referred to as only ITC or Notified body)

2. Name of the client : ………………………………..

Address : …………………………….

banking with: …………………………..

Account No.: ……………………………

SWIFT Code: ……………………………………

having company's tax registration number: ……………………(if any)

person responsible for the matter of Agreement: ……………….. email: ………………

person responsible for the technical matters: ………………….. email: ………………

represented by: …………………………….. email: ………………

(Hereinafter referred to as only Client or Manufacturer)

Article II

Aim of the agreement

1.Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices, Directive 98/79/EC on in vitrodiagnostic medical devices, hereafter named "Directives on medical devices", contain certain legal requirements with regard to the audits, assessments and unannounced audits performed by notified bodies in the field of medical devices (see

2.The aim of this agreement is to ensure a proper verification by ITC that the client fulfills all relevant legal requirements laid down in"Directives on medical devices".

3.Subject to the respective conformity assessment procedure, ITC performs product assessments or quality system assessments. In order to verify the day-to-day compliance with all relevant legal obligations, notified bodies should perform regular, extraordinaryand unannounced audits. ITC will perform theregular, extraordinary and/or unannounced audits in compliance with this principle in addition to the product conformity assessment and initial quality system assessment.

Article III

Duties and responsibilities of ITC

  1. In the case of Full Quality Assurance System, the surveillance performed by ITC should ascertain that the application of the quality system assures the conformity of the devices with legal requirements of the "Directives on medical devices". In the case of Production or Product Quality Assurance, the verification should ascertain that the application of the quality system assures the conformity of the devices with the device typeand meet the provisions of the respective Directive which apply to them.
  1. The quality system verification should include audits in the premises of the manufacturer and, if appropriate, of his critical subcontractors or of his crucial suppliers.
  1. ITC should identify which products the manufacturer regards as covered by his application, whether these products fall under the ”Directives on medical devices” and whether there have been changes to these products or to the quality system since the last audit or since the application submission. Furthermore, ITC should identify the post-market information about the product, available to ITC or to the manufacturer, which might need to be taken into account when planning and performing the audit.
  1. If any nonconformity of a device is detected ITC should investigate if the nonconformity was caused by the quality system itself or its incorrect application. If a test has been carried out, ITC should provide the client with the test report and an audit report which highlights in particular the link between quality system deficiencies and detected non-conformities of the devices.
  1. ITC should verify the existence of a product identification system. This system should ensure that the ITC's certificates, the manufacturer's declarations of conformity and the manufacturer's technical documentations can unequivocally be attributed to certain devices and not to others.
  1. ITC should verify the client’s working instructions with regard to the product documentation. The working instructions relating to the product documentation should ensure that all products intended to be placed on the market or put into service are covered by the necessary certificates issued or to be issued by the ITC. The instructions with regard to the products (certified by ITC) documentation should also ensure that all products intended to be placed on the market or put into service, regardless of their trade name, are covered by the declarations of conformity of the manufacturer and that these are contained in and are compatible with the technical documentation. ITC should verify the correct execution of these instructions by sampling the product documentation of individual devices.
  1. In case of manufacturers of medical devices other than in vitro diagnostic devices, ITC should verify that the client’s working instructions on clinical evaluations and the post-market clinical follow-up are complete and correct and are correctly implemented. ITC should examine clinical evaluations and the post-market clinical follow-up for the device types covered by the application or certificate issued by ITC. ITC should verify the correct execution of these instructions by checking the product documentation of individual devices.
  1. In case of manufacturers of in vitro diagnostic medical devices, ITC should verify the client's working instructions on performance evaluations and correct execution of these instructions by checking the product documentation of individual devices.
  1. ITC should verify that the manufacturer controls the manufacturing environment and processes in order to assure the conformity of the devices with the legal requirements laid down in "Directives on medical devices". ITC should pay special attention to critical processes such as design control, establishment of material specifications, purchasing and control of incoming material or components, assembling, software validation, sterilization, batch-release, packaging, and product quality control, regardless of whether they are subcontracted by the client or not.
  1. ITC should verify the manufacturer's system ensuring traceability of materials and components, from the entry into the manufacturer's, supplier’s' or subcontractors' premises to the delivery of the final product.
  1. ITC should verify that experience gained in the post-production phase, in particular vigilance data, is systematically collected and evaluated on the day-by-day basis by client for the devices covered by the application or certificate issued of the manufacturer and that the necessary improvement of the devices or of their production has been initiated. ITC should in particular verify that all distributor related business processes are suitable for providing information indicating the need for reviewing the design of the device, its manufacturing or the quality system.
  1. At each annual surveillance audit (regular audit), ITC should verify that the client correctly applies the approved quality management system and the post-market surveillance plan. A product sample could be taken in order to assure its inspection or testing arranged by the ITC. In such case, the test report should be delivered to the client.
  1. ITC should carry out unannounced audits at least once every three years.In case of the Class III medical devices, Active implantable medical devices and List A In-vitro diagnostics, the frequency increases to at least one unannounced audit per two years. ITC should increase the frequency of unannounced audits if the devices of the respective type are frequently non-compliant or if specific information provides reasons to suspect non-conformities of the devices or of their manufacturer. The timing of the unannounced audits should be unpredictable.
  1. ITC may, instead of visiting the manufacturer or in addition to it, visit one of the premises of the manufacturer's critical subcontractors or crucial supplier’s if this is likely to provide more pertinent information.
  1. Within the context of such unannounced audits, ITC should check a recently produced adequate sample, preferably a device taken from the on-going manufacturing process, for its conformity with the technical documentation and with legal requirements. The check should encompass a file review and a product sample testing.
  1. To prepare the test, ITC should, during or after the unannounced audit, request from the manufacturer all relevant technical documentation including previous test protocols and results. The test should be undertaken in accordance with the testing procedure defined by the manufacturer in the technical documentation which has to be validated by the ITC. The test may also be performed by the manufacturer under observation of the notified body ("witness testing"). The control of the device conformity should include the verification of the traceability of all critical components and materials and of the manufacturer's traceability system.
  1. If the sampling in the manufacturer's premises is not possible ITC should take samples from the market, if necessary with support of the competent authorities, or should perform testing on a device installed at a customer location. To prepare the test ITC should request from the manufacturer all relevant technical documentation including final batch testing reports, previous test protocols and results.
  1. In the case of unannounced audit ITC should check critical processes such as design control, establishment of material specifications, purchasing and control of incoming material or components, assembling, software validation, sterilization, batch-release, packaging, or product quality control. Amongst the suitable critical processes, ITC should select one which has a high likelihood of non-conformity and one which is particularly safety relevant.
  1. A client’s application for recertification should be accepted by ITC provided that the application will be delivered to ITC two months before actual certificate validity expirationat the latest.

Article IV

Duties and responsibilities of the client

  1. Client is obliged (in the case of Full Quality Assurance System) to operate the quality system which assures the conformity of the devices with legal requirements in the "Directives on medical devices". Client is obliged (in the case of Production or Product Quality Assurance) to operate the quality system which assures the conformity of the devices with the device type and meet the provisions of the Directive which apply to them.
  1. Client agrees with regular and unannounced audits and will make full effort to enable such audits performed by ITC in the premises of the manufacturer and of his critical subcontractors or of his crucial suppliers and is ready to pay for them according to conditions described and agreed on in a separate financial agreement.

Client is aware of the fact that when regular and/or unannounced audits would not be executed due to client’s non-cooperation, ITC could suspend or cancel the issued certificate.

Client is obliged to inform ITC about the following items:

Task / Frequency
Clinical evaluation – MEDDEV. 2.7.1 Rev.3 / Regularly update 2 times per year
Clinical investigation - MEDDEV 2.7/4 / Regularly update 2 times per year
Post marketing follow-up - MEDDEV 2.12/2 rev2 / Regularly update 2 times per year
Vigilance information – MEDDEV 2.12-1 rev 7 / Regularly update 2 times per year
Adverse events and their solution / Immediately, and regularly update 2 times per year
Information about countries, where the corresponding product was or has been introduce on the market and put in to operation / Regularly update 2 times per year
Information about authorized representative in Europe / Immediately after any change,
regularly once a year
Any significant changes in quality system / Immediately, regularly once a year
Any significant changes in the design of the product / Immediately, regularly once a year

(See e.g.

Client is aware of the fact that in case this necessary information should not be sent to ITC not even after it is appealed, ITC could suspend or cancel the issued certificate (certificates).

  1. Client is obliged to operate a product identification system. This system should ensure that the ITC's certificates, the client’s declarations of conformity and the client's technical documentations can unequivocally be attributed to certain devices and not to others.
  1. Client is obliged to have working instructions with regard to the product documentation. The working instructions relating to the product documentation should ensure that all products intended to be placed on the market or put into service are covered by the necessary certificates issued or to be issued by the ITC.
  1. Client is obliged to control his manufacturing environment and processes so as to assure the conformity of the devices with the legal requirements. Client is obliged to operate a system ensuring traceability of materials and components, from the entry into the manufacturer's, supplier’s' or subcontractors' premises to the delivery of the final product.

Client is aware of the fact that if the traceability of materials and components would not be sufficient, ITC could suspend or cancel the issued certificate(s).

  1. Client is obliged to operate a system of collecting the information in the post-production phase, in particular vigilance data, on the day-by-day basis.
  1. Client agrees, that ITC will take photo-pictures of the product, its packaging, labelling and/or accompanying documentation in the course of regular or unannounced audit.
  1. Client agrees that ITC will carry out unannounced audits at least once every third year and is ready to pay for them according separate financial agreement. ITC should increase the frequency of unannounced audits if the devices bear a high risk, if the devices of the respective type are frequently non-compliant or if specific information provides reasons to suspect non-conformities of the devices or of their manufacturer.

Client agrees that the unannounced audits can be realized also on the premises of the manufacturer's critical subcontractors or crucial supplier’s if this is likely to provide more pertinent information.

Client is aware of the fact that when regularly and/or unannounced audits according previous paragraph would not be executed due to client’s or his subcontractor’s non-cooperation, ITC could suspend or cancel the issued certificate(s).

  1. Client agrees, within the context of such unannounced audits, that ITC will check a recently produced adequate sample, preferably a device taken from the on-going manufacturing process, for its conformity with the technical documentation and with legal requirements.
  1. Client agrees, that to prepare the test, ITC will, during or after the unannounced audit, request from the manufacturer all the relevant technical documentation including previous test protocols and results. The test should be undertaken in accordance with the testing procedure defined by the manufacturer in the technical documentation which has been validated by the ITC. Another tests could be performed proving that harmonized and other standards specified in the technical documentation were really applied. The test may also be performed by the manufacturer under observation of the notified body ("witness testing"). The check of the conformity of the device should include the verification of the traceability of all critical components and materials and of the manufacturer's traceability system.

Client agrees with this testing and is ready to pay for it according to conditions stipulated in a separate financial agreement which can include also costs for shipping.

  1. Client agrees that if the sampling in the manufacturer's premises is not possible ITC can take samples from the market, if necessary with support by the competent authorities, or should perform testing on a device installed at a customer location. For this client is obliged to send on ITC’s request all the relevant technical documentation including final batch testing reports, previous test protocols and results. Client agrees with this testing and is ready to pay for itaccording toa separate financial agreement.
  1. Client agrees unannounced audits in premises of the manufacturer or of his critical subcontractors or crucial suppliers is to be foreseen in this arrangement.

Article V

Confidentiality

  1. The parties hereto shall keep in strict confidence and shall not disclose to any third party any information which is acquired in connection with a performing of this agreement. The only exclusion for ITC is to inform authorities, governmental, surveillance agencies as it is set in the corresponding legislation acts (see
  1. In addition to the foregoing, no party shall be entitled to use the information for purposes other than those expressly set forth in the present agreement.
  1. The confidentiality obligation contained in this Article shall not apply to information which the parties hereto lawfully received from third parties or which is accessible in the public domain.

Article VI

Contacts

  1. In order to efficiently and continuously carry out the mutual process both parties commit to assign points of contact for technical questions and process administration.
  1. Where the accreditation rules and respective EU directives allows for it, the electronic message (e-mail) sent from the appointed contact person’s address shall have equal validity as the registered letter.

Article VII

Validity of the agreement

  1. The General framework agreement enters into force after ratification by both parties’ representatives.
  1. This General framework agreement is valid till the end of the validity of the certificate (certificates) issued by ITC to the client.

Article VIII

Final provisions

  1. This agreement is established on the amicable principle and both parties should act by the spirit of its provision.
  1. Should individual provisions of the present agreement not be applied, this shall not affect the balance of the agreement and intended aims.
  1. All disagreements, claims and breach of the present Agreement, which would not be settled by the parties’ authorized representatives during period of 6 months, shall be resolved by judicial procedures. The applicable legislation is the legislation of the Czech Republic.
  1. The present agreement can be modified and/or amended in writing on the basis of mutual understanding.

Done in Zlín

On …………………

For ITC :

Dr. Radomír ČEVELÍK

Director General

Institut pro testování a certifikaci, a. s.

For the client:

Name : …………………………………..

Position in the company (producer) : ……………………………….

Company : ………………………………

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