REGULATION FOR THE CE CERTIFICATION ACCORDING TO THE MEDICAL DEVICES DIRECTIVE

Transcription

1 TABLE OF CONTENTS 1. PURPOSE AND FIELD OF APPLICATION 2. GENERAL PRINCIPLES AND GUARANTEES FOR THE CUSTOMER 3. ACCESS REQUIREMENTS FOR CERTIFICATION 4. REQUIREMENTS OF THE ASSESSMENT PROCESS 5. SUSPENSION, REVOCATION, REDUCTION OF THE CERTIFICATION 6. INCORRECT USE OF CERTIFICATION, THE CERTIFICATE AND CE MARKING 7. MANUFACTURER OBLIGATIONS (OR AUTHORIZED REPRESENTATIVE) 8. CLAIMS, APPEALS AND DISPUTES Rev. Summary of change Date 7 Aligning terminology, introduction of the certification procedure details and rights - duties of the parties. 6 Introduction ref. to main bodies, the new terms and conditions of supply access requirements, irregularities classification and management, claim management Verified by: Quality and Industrialisation Director Maria Anzilotta Signature on paper Approved by: Chief Operating Officer Giampiero Belcredi Signature on paper Whole or partial reproduction of this document with any means is prohibited unless otherwise authorised by Kiwa Cermet Italia. rev. 7 of Page 1 of 15

2 1. PURPOSE AND FIELD OF APPLICATION These Regulations define the rights and duties, as well as the operational methodology that governs the relationships between Kiwa Cermet Italia S.p.A. (hereinafter, Kiwa Cermet in short) and the Manufacturer or Authorized Representative (hereinafter the Customers), in the implementation of the procedures to be used for conformity assessment of medical devices (hereinafter MD), provided in Article 11 and Article 12 of the Directive 93/42/EEC, as amended (hereinafter the Directive), in accordance with the provisions of Annexes II, V, VI of the Directive. In addition, the conformity assessment activities are carried out in accordance with applicable European directives and guidelines as well as sector regulations in their harmonised versions at the time of execution of the activities, as said documents contain additional requirements with respect to the above Directive. The requirements indicated in these regulations form an integral part of the contract entered into with Kiwa Cermet (financial quotation and General Terms and Conditions of Kiwa Cermet Italia for the performance of tasks). These requirements refer only to aspects specifically associated with the field of application of the requested certification. In case of discrepancy between the Italian version and English version of any documents relevant to the procedure for certification purposes, the Italian version of the document shall prevail. For the definition of a medical device, manufacturer and Authorized Representative, what is stated in Article 1, paragraph 2 of the Directive applies. The product types for which Kiwa Cermet is authorised to operate are shown in the notification Authorisation for issue of the EC compliance certification for the conformity of medical devices issued to Kiwa Cermet Italia by the Competent Authority. The object of the Contract expressly excludes any form of consulting to the Customer that may jeopardise the independent nature of the evaluations carried out. These Regulations are also available on the Kiwa Cermet website ( In any case, customers wishing to conclude a contract with Kiwa Cermet can ask for a computerised copy. In addition, Kiwa Cermet shall notify the Customer of all subsequent amendments to the contract documents; it is however the customer s responsibility to always have the latest version of said documents, downloading them from the website. 2. GENERAL PRINCIPLES AND GUARANTEES FOR THE CUSTOMER During its conformity assessment activities, in addition to what is specified in the General Terms and Conditions, Kiwa Cermet applies the following principles: a) Lack of discrimination: access to certification services is allowed to any Customer that requests them in compliance with these Regulations, without any discriminatory condition of a commercial, financial nature or associated with membership in special associations b) Impartiality and independence, guaranteed through the following measures: - Performance of the certification activities assigned to individuals having no interest of any kind in the Customer being certified, and required to abide by the rules of behaviour and independence established by Kiwa Cermet; with regard to this, Kiwa Cermet agrees to accept any justified reports from the Customer, within 3 days from reporting of the regulations concerning the existence of assignment incompatibility issues which may jeopardise impartiality or opinion independence. - The timely application of formalised rules and procedures by all certification services personnel and periodic consultation with suitable stakeholders involved in the certification; - Clear separation of personnel carrying out assessment activities and personnel taking part in the certification decision: - Totally abstention from providing assistance during the definition and application of the requirements needed to obtain the Certification. c) Timely management of claims, appeals and litigation, as defined in 8 of these Regulations; rev. 7 of Page 2 of 15

3 d) Confidentiality: in addition to what is regulated in the General Terms and Conditions of Kiwa Cermet, all customer data and information is managed in strict confidentiality, unless otherwise prescribed by the Provisions of law. In addition, Kiwa Cermet arranges for having all its personnel, including personnel conducting conformity assessments, sign a confidentiality agreement as well as a document in which all personnel agree to process any data or information which they may gain possession of in compliance with the provisions of the Privacy Law; Similar commitment to privacy is guaranteed by the control bodies and designating authorities to which Kiwa Cermet must ensure access to the data of its Customers. e) Notification: Kiwa Cermet agrees to notify the Customer with regard to any waiving, suspension or revocation of ministerial notification; in these cases, Kiwa Cermet shall in no way be responsible for any damage caused to the Customer as a result of the waiving, suspension or revocation of the notification; in the aforementioned cases, the Customer shall be entitled to waive the contractual relationship with Kiwa Cermet, without any need for advance notice and additional charges. 3. ACCESS REQUIREMENTS FOR CERTIFICATION 3.1 General requirements The Customer, prior to undertaking the Certification procedure with Kiwa Cermet, has to meet the following requirements: - Accept the conditions set forth in these Regulations: - Ensure Kiwa Cermet Staff and the staff involved in the resolution of claims all the facilities necessary to carry out conformity assessment activities, including those for the analysis of the documentation, and access, during the audit, to all areas subject to assessment, the documents and recordings (including internal audit reports); - Appoint one s own Representative as the main contact person of the Audit Team and have any consultants present during the audit carry out the role of observers; - Be responsible for the application of the requirements provided for by the occupational safety laws in force. In the absence of binding provisions, the Customer agrees to provide Kiwa Cermet with complete and detailed information pertaining to the specific risks existing in the environment where Kiwa Cermet staff is intended to operate. Therefore the Customer undertakes to implement, as well as to encourage, through a specific designated person, protection and prevention measures against any workplace risks having an impact on the activities of Kiwa Cermet s Auditors and that require workers and all others who operate or are present in the same work environment to be protected. - Accept without additional charges, the possible presence of: Personnel from the control body who shall be communicated by Kiwa Cermet with a clear illustration of their roles. The purpose of the Evaluators presence is to ascertain that the evaluation methods adopted by Kiwa Cermet comply with notification requirements; Kiwa Cermet Personnel being trained; Kiwa Cermet personnel acting as observers, who have the purpose to carry out on-field monitoring activities with regard to the correctness of the assessments and services provided to Customers. 3.2 Results of conformity assessment activities For the requirements contained in these Regulations, any problem encountered in the course of conformity assessment is classified as follows: Findings: Only in the documentation analysis phase a finding occurs in a situation where requirements are not met in the technical documentation and management system for the quality applied to the medical device subject to certification. In addition, you may also have a finding also in relation to other documents not specifically required by the Directive, but in which a deficiency may adversely affect the conformity of the medical device. Major Non-Conformity (NC): Only in the audit phase - a major NC event occurs if there is a failure to fulfil a requirement laid down by the applicable legal regulations, which affects the ability of the Management System to achieve the expected results, and therefore the safety, fundamental performance, technical features or functionality of the product. It may concern: rev. 7 of Page 3 of 15

4 - Deviation or total lack of conformity with respect to a specified requirement, identified on the basis of objective evidence; - Non-compliance with applicable legal requirements. Minor Non-Conformity (NC): Only in the audit phase - a smaller NC event occurs in case of a failure to fulfil or partial fulfilment of a requirement laid down by the applicable legal regulations which, despite being indicative of inappropriate behaviour by the customer and, as such, in need of correction, does not affect the ability of the Management System to achieve the expected results and therefore does not fall in the non-conformity cases described above. Multiple minor non-conformities pertaining to the same requirement may entail the issuing of a major NC in relation to the contents and the general outcome of the audit. Minor non-conformities that have not be solved and/or not acknowledged by the Customer may entail the issuing of a major NC. Improvement elements: what is not covered in the NC definitions and which constitutes a possible improvement of the management system or product subject to certification. 4. REQUIREMENTS OF THE CONFORMITY ASSESSMENT PROCESS 4.1 General Requirements Kiwa Cermet s activity is carried out in compliance with all the requirements that must be held by Notified Bodies, as prescribed by the Competent Authority at national level. The Customer who intends to make use of Kiwa Cermet for the CE marking of its MD is responsible for the specific intended use assigned to each device and its classification as reported in Article 1 and Annex IX of the Directive respectively. If between the Customer and Kiwa Cermet there is a disagreement regarding the application of the classification rules, Kiwa Cermet, after informing the Organisation, shall send details of the points of disagreement to the Competent Authority, which will decide what to do. The Customer chooses, as provided in Article 11 of the Directive, the conformity assessment procedures in order to affix the CE marking on the MD in relation to the classification thereof. Therefore different possibilities are envisaged for the Customer, grouped for convenience into several options, depending on the different procedures for assessing conformity set out in Article 11 of the Directive. The certification paths followed by Kiwa Cermet for CE marking and its maintenance according to the various options are as follows: Complete System with quality assurance according to Annex II of the Directive; Quality assurance of production according to Annex V of the Directive; Quality assurance of the product according to Annex VI of the Directive; Following each audit described below the following shall apply: After each audit, the Audit Group meets for the assessment of the recorded evidence, its classification and the drafting of a report. In the final meeting, the Audit Group submits the Audit results to Management and the conclusions concerning the compliance of the Management System applied to the Directive, mentioning, any Non Conformities discovered. After the meeting, the Lead Auditor issues a report describing the Audit findings. Any diverging opinions between the Audit Group and the Customer regarding the audit findings or conclusions must, where possible, be discussed and resolved. In the case of any unresolved diverging opinions, the Customer can express reservations about the Audit results. In the event NCs are recorded, the Customer must define and implement appropriate processes, a root cause analysis and corrective actions, with a precise, clearly planned procedure with respect to the methods and timing of implementation. The Customer must notify said action plan to Kiwa Cermet within a reporting period, as provided in the following paragraphs. rev. 7 of Page 4 of 15

5 Improvement elements must be analysed by the Customer, who will decide whether to define the subsequent actions for their implementation or not. If the Customer decides not to act on the improvement element, it must however report the analysis performed and the reasons for non-transposition; in the latter case, Kiwa Cermet reserves the right to further examine the aspect reported. 4.2 Contractual Procedure Request for Conformity Assessment To gain access to certification services for medical devices, the Customer must complete the information questionnaire prepared by Kiwa Cermet and sent on request. In the questionnaire, the Customer must specify at least the following information in detail: - Personal data: company name, name, address and legal status, any remote operating locations - Description of the products to be certified, their classification and rule; - Choice of the conformity assessment procedure; - Any outsourcing providers who are entrusted with critical processes that impact on the products subject to certification (components, semi-finished products, sterilisation, special processes, etc.) Together with the duly completed information questionnaire, the Customer must send Kiwa Cermet the annexes required by the latter, and in particular the following documents: - Certificate of registration of the Chamber of Commerce (copies on unstamped paper) or equivalent document for foreign countries; - Any quality management system certificates held by the Customer or its critical suppliers. In case of certification renewal, the customer will be sent another questionnaire directly by Kiwa Cermet to confirm the data already held by Kiwa Cermet and the Customer's willingness to continue with certification renewal Preparation of the offer Based on the information reported in the questionnaire, Kiwa Cermet prepares the financial quotation for CE marking certification, containing the description of the service offered, complete with all information relating to the activities, and the prices determined in accordance with the rates in force. In the event that from the information contained in the questionnaire aspects were to emerge due to which Kiwa Cermet cannot guarantee the ability to perform the certification activity, said situation shall be communicated to the Customer with the refusal of the request for conformity assessment and the reasons, and the offer will not be issued Acceptance of the offer Acceptance of the offer by the Customer establishes the contractual relationship between the parties and constitutes the formal request for conformity assessment activities for the purposes of CE marking. Acceptance of the offer also implies acceptance of the specifications provided in these Regulations and in Kiwa Cermet s General Terms and Conditions for performance of the tasks document, mentioned in the offer. In the event that the Manufacturer intends to transfer the certification issued by another Notified Body to Kiwa Cermet, it should inform Kiwa Cermet of the existence of relationships with the other Body for the same type of medical devices, as well as make the documents available relating to the conformity assessment carried out in the period of certification, and the related CE certificates in force Re-examination of the offer and order confirmation Once Kiwa Cermet has received the signed offer and all the documents requested therein and in the questionnaire, it will re-examine said documentation, ensuring that: - The data and documents required have been provided in a comprehensive manner; - Both parties have clearly defined and understood the certification service requirements; - Kiwa Cermet is able to perform the required tasks; - There are no differences compared to the data provided at the time of the request for quotation. rev. 7 of Page 5 of 15

6 If the outcome of the review is positive, the certification procedure is started. In case of a negative result, Kiwa Cermet is entitled to request any necessary additions or changes before the formal start of the procedure, or communicate the impossibility for said start, providing the Customer with reasons. Furthermore, if in the process of document assessment or audit inconsistencies emerge with regard to statements made in the questionnaire, the offer may be subject to review by Kiwa Cermet Planning of the conformity assessment activities The conformity assessment activities include: 1. Documentation analysis; 2. Planned audits at the headquarter/s of the Organisation (as described below); 3. Unannounced audit. Depending on the type of request made by the Customer (for e.g. new certification, extension, amendment), Kiwa Cermet determines which conformity assessments need to be performed (described in the offer) and defines the resources to be involved. Tasks can be assigned to employees or qualified external collaborators according to the requirements of the reference documents and Kiwa Cermet procedures. Should a situation arise that requires the sub-contracting of part of the certification process, Kiwa Cermet shall implement all measures necessary to ensure that the subcontractor complies with the provisions of reference and Kiwa Cermet system documents. The liability for any subcontracted activities is borne by Kiwa Cermet. 4.3 Analysis of documentation The analysis of the complete technical file 1 and Quality System documentation is performed, unless otherwise agreed by the parties, at Kiwa Cermet s premises by staff holding the necessary technical expertise relating to the scheme and the type of product to be certified. The customer must keep a controlled updated copy of the technical file for Kiwa Cermet and Quality System documentation and make it available during the evaluation activities and for the entire term of the evaluation contract with Kiwa Cermet. At the end of the documentary analysis, the customer is issued a report summarising the outcome, with any remarks. Depending on the result of the analysis of the documentation, the Customer may decide at its sole discretion whether to integrate or modify the documentation on the basis of the irregularities, or terminate the certification process. When the customer submits the supplementary or amended documentation, an evaluation of the revised documentation is performed. The presence of irregularities during document analysis does not allow subsequent phases of the certification to be performed until complete resolution thereof and receipt of the duly updated documentation, reviewed and approved by Kiwa Cermet. In special cases established by Kiwa Cermet, the irregularities that emerged in the process of document analysis during the on-field audit can be closed, if provided for, e.g. as a result of no substantial remarks or where the resolution is easily verified during the next phase of the audit. The successful completion of the analysis phase of the documentation must finish within 1 year from the date of the first analysis of the documentation; beyond said limit, Kiwa Cermet will assess the subsequent actions (including for example interruption of the certification). In this case, the request for a new certificate must be submitted to Kiwa Cermet s approval and in any case not be carried out earlier than 6 months from the previous one. 4.4 Certification audit The certification audit is performed following the analysis of the documentation at the sites where the activities related to the products to be certified take place, with a view to assessing that the quality system verified during document analysis is applied in all the life cycle phases of the device for which certification is requested. In particular: 1 To be considered complete, the Technical file must deal with at least the items listed in the GHTF document Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performances of Medical Devices (STED) in as much detail as possible, in addition to any other items required by the European legislation applicable during the conformity assessment (ref. and the relevant annexes referred to. rev. 7 of Page 6 of 15

7 - It shall provide for the assessment of all device features with regard to documents and application; - It shall provide for quality system assessment regarding the product. The certification audit is planned so as to take into consideration all the requirements of the Directive relating to the Annex chosen for conformity assessment. In defining the aspects to be verified, Kiwa Cermet decides any critical suppliers that will be audited. In particular, there will be no audits in the following cases: 1. Suppliers who have an ISO quality management system accredited by a Certification Body, except for all class III devices and innovative devices; in said cases, critical suppliers will always be audited. 2. Suppliers who have certification for medical schemes (ISO or CE marking) with Kiwa Cermet; 3. Suppliers who perform sterilisation services and/or surface treatments widely adopted and with the application of harmonised standards, known on the market for reliability and for which market return issues have never occurred; 4. Accredited or quality management system certified testing laboratories by an accredited certification body, or authorised Test Facilities for Good Laboratory Practices (GLP). The Lead Auditor prepares an activity plan which is sent to the customer. Any changes to the plan can be agreed on the basis of Customer requirements during the initial meeting during audit. Where appropriate, in the initial phase of the audit the resolution of any irregularities reported in the analysis document is also evaluated. Any unresolved irregularities are included in the audit report as major NCs. During said audit, Kiwa Cermet may carry out or have tests carried out. Kiwa Cermet can perform sampling and execution of laboratory tests on the medical device to be certified. To this end, an adequate sample of the final products must be taken on site, and the appropriate tests defined in the corresponding standard, or equivalent tests, must be performed. During the certification audit the Lead Auditor prepares the audit programme. This programme represents the basis for the subsequent detailed planning of each audit. At the end of the audit, the Audit Team gives a copy of the audit report to the customer who signs it. The audit report is subjected to internal analysis and approval by Kiwa Cermet in view of the final approval of the certificate. If any NCs are encountered, the Customer must send the proposed corrections and corrective actions identified (upon the analysis and formalisation of the causes that generated them), along with implementation timing, to Kiwa Cermet s Lead Auditor via the appropriate form within 20 working days from the date of the audit. The Lead Auditor shall assess the actions proposed and, in case of acceptance, communicate them to the Customer. Kiwa Cermet cannot proceed with the certification approval until receipt of the proposals for resolution and corrective actions accepted by the Lead Auditor. The implementation and effectiveness of changes and corrective actions referring to minor NCs is monitored by Kiwa Cermet during the Surveillance audit for the next period. In addition, in the case of major NCs, approval cannot proceed until also implementation of changes and corrective actions have been audited through an additional conformity assessment according to the assessment procedures established by the Lead Auditor (audit at the customer s premises and/or by means of document analysis where possible). Said assessment must be carried out within 6 months from the audit certification; beyond said limit, Kiwa Cermet will decide, at its discretion, whether to assess the subsequent actions. In the event of a positive outcome of the additional assessment, the certification procedure will continue with the next steps for the approval of the certificate. In case of failure, the certificate cannot be issued. In the latter case, Kiwa Cermet assesses the subsequent actions that may provide additional conformity assessment activities, the launch of a new certification activity, or the interruption of the procedure. The approval of the certificate is conducted by different members with technical and clinical expertise at different times. Members, even though in possession of all the skills and qualifications required by the certification scheme, cannot in any way taking part in the conformity assessment activities. During the certificate approval process, members may feel it necessary to request clarification, additional conformity assessment activities or additions from the Audit Team. Each different assessment with regard to the Audit Team is communicated to the customer. In the rev. 7 of Page 7 of 15

8 event of a positive outcome of the approval process, Kiwa Cermet issues a declaration of conformity which is sent to the customer. Upon receipt of the CE certification, the customer applies Kiwa Cermet s 0476 identification number on the devices subject to certification. In case of certificate refusal, Kiwa Cermet shall send the customer a notification specifying the related consequent actions as provided during the Certification Decision Phase. In these cases, the request for a new certificate must be submitted to Kiwa Cermet for approval. The Kiwa Cermet Certificate is valid for 5 years from date of issue. The expiry date of the certificate cannot be changed, even if the certificate is extended. Any request to modify the certificate content should be sent to Kiwa Cermet in writing. 4.5 Surveillance Audit Surveillance audits are performed annually (with reference to the month of certificate expiry). They are always performed at the sites where they carry out activities related to products subject to certification. The purpose of the surveillance audit is to check the maintenance of the conditions that led to the granting of the certification, as well as any subsequent changes to the process or the products, if previously required (the times must be sufficient to assess the request, issue an offer and reviewing the offer) and approved by Kiwa Cermet Italia. The surveillance audit is based on a sampling of the activities subject to certification, ensuring complete audit of the management system and technical documentation during the certification cycle. In addition, the surveillance audit must include the check of any critical suppliers as defined in the audit programme issued after the certification audit. During the surveillance audit the evaluation of the resolution of non-conformities in previous audits is carried out, as well as assessing the implementation and effectiveness of the corrective actions taken by the Customer. During said audit, Kiwa Cermet may carry out or have tests carried out. Kiwa Cermet can perform sampling and execution of laboratory tests on a certified medical device. To this end, an adequate sample of the final products must be taken on site, and the appropriate tests defined in the corresponding standard, or equivalent tests, must be performed. At the end of the audit, the Kiwa Cermet Audit Team gives a copy of the audit report to the customer who signs it. The report shall be deemed confirmed if no further communications are received by Customer within 60 calendar days. If any NCs are encountered the customer must send on the appropriate form within 20 working days from the date of the audit to Kiwa Cermet s Lead Auditor, the proposal relating to the corrections and corrective actions identified (upon the analysis and formalisation of the causes that generated them), within implementation timing. The Lead Auditor shall assess the actions proposed accepting the proposals or not and shall communicate it to the Customer. The action plan shall be deemed confirmed within 90 calendar days from the acceptance date of the corrective actions by the Lead Auditor if no further communications are received by the Customer The implementation and effectiveness of changes and corrective actions referring to minor NCs is monitored by Kiwa Cermet during the Surveillance audit for the next period. In addition in the case of major NCs, implementation of the corrections and corrective actions must be audited through an additional assessment according to the procedures established by the Lead Auditor (audit at the customer and/or documented evidence where possible). Said assessment must be carried out within 6 months from the audit surveillance; beyond said limit it will be at Kiwa Cermet discretion to assess the subsequent actions. In case of a positive outcome of the above assessment the certification procedure is confirmed. In case in which the customer fails to implement the agreed actions for the approval of the irregularities within the terms approved, certification may be suspended or revoked on the decision of Kiwa Cermet. The execution of surveillance audits planned during the certification cycle is subject to regular payment of invoices for previous activities by the Organisation. Conversely Cermet Kiwa reserves the right not to carry out the planned activities and to proceed with certificate suspension. rev. 7 of Page 8 of 15

9 4.6 Extension or amendment audit In case of extension or amendment request, the necessary activities will be managed in accordance with the instructions given in 4.3 and/or 4.4. Following an internal assessment Cermet Kiwa reserves the right to make the extension or amendment activities at its offices (through document analysis) or at the Customer. The detailed path for the extension or amendment of the certification is communicated to the Customer. 4.7 Renewal audit At least 2 months before the deadline, Kiwa Cermet performs a renewal audit which aims to allow for an effective review, also in terms of documents, of the conformity of the products to be certified with the essential requirements of the Directive. Upon renewal, the management system progress over five years is reviewed. The management of the audit results occurs according to the same method described in 4.4. Operations and formalities required for the renewal of the certificate must be completed before the certificate expiry date. Kiwa Cermet decides whether to renew the certificate or not, based on the audit renewal results. Following renewal, the certificate will be confirmed for further 5 years. Performing an audit renewal is subject to the regular payment of the aforementioned activities by the Organisation, otherwise Cermet Kiwa reserves the right not to perform the tasks envisaged for the renewal audit. If the customer does not intend to proceed with the certificate renewal, or the renewal is not completed within the deadline, the Customer shall retain the right to market the products whose manufacture has taken place before the expiry date of the certificate; this issue, however, must occur within 6 months from the expiration date thereof. The products not in stock at the certificate expiry date will no longer show reference to certification and can no longer be marketed. In the event that the Organisation intends to market the products in the warehouse, it must send specific communication to Kiwa Cermet signed by its Legal Representative with said request and specify: products, batches and quantities in stock. Kiwa Cermet shall assess whether to approve said request or not and reserves the possibility to perform an audit at the customer's warehouse to check the actual inventory of products in stock and production dates. 4.9 Additional Audit (or follow-up) Cermet Kiwa reserves the right to conduct additional Audits for the following types of situations: - Audit for the implementation of changes and corrective actions to close non-conformities or requests arising under the Certification Decision phase; - Reactivation of suspended certifications; - Audits to authorise marketing of products in the warehouse; - Obtaining information of serious accidents, emergencies or malfunctions; - Receiving claims, or reports in general or news regarding non-conforming aspects related to certified medical devices; Any such additional audits performed by the Organisation do not replace and do not change the process and the frequency of annual surveillance audits Unannounced audit Kiwa Cermet performs unannounced audits at the sites where activities related to the products subject to certification are carried out (these can also include local critical suppliers), to check the daily compliance with legal requirements by the Customers in the Medical Devices industry, as required by the European Commission Recommendation of 24 September /473/EU concerning the checks and assessments carried out by Notified Bodies in the Medical Devices industry. Kiwa Cermet can increase the frequency of audits without notice, for example in cases where the devices have a high hazard potential and/or they are often non-compliant and/or have specific reasons for suspicion on the compliance of the devices and/or the Manufacturer. rev. 7 of Page 9 of 15

10 In order to ensure the proper conduct of unannounced audits, the Customer agrees to provide Kiwa Cermet with information on the periods of the year (company closures, holidays, etc.), where the manufacture of the medical devices subject to certification is not planned. In addition, the Customer undertakes to include, in contracts governing the relationship with its critical suppliers, the prior authorisation for Kiwa Cermet to access the premises/establishments where production, storage and monitoring activities related to the medical devices subject to certification are conducted. Similarly, critical suppliers must undertake to provide the Customer, who in turn will promptly inform Kiwa Cermet, with information on the periods of the year (company closures, holidays, etc.) where the manufacture of the medical devices subject to certification is not planned. The Kiwa Cermet Audit Team arrives at the sites where activities related to the products subject to certification are conducted, identifying themselves by identification badges and letters of identification and authentication. In the context of an unannounced audit, Kiwa Cermet conducts controls on a suitable sample of recently manufactured medical devices, preferably taking them from the manufacturing process in progress at the time of the audit, for the purpose of ascertaining, even through trials, conformity with the technical documentation and the legal provisions. During an unannounced audit the following occurs: - Maintenance of conformity of the devices subject to sampling, with regard to the approved technical documentation (technical file examination) and the provisions of law; - The traceability of all components and critical materials used, in particular by comparing the correspondence between the purchased materials and the outgoing finished products; - Maintenance of conformity of the management system for approved quality. In addition, during an unannounced audit, trials/tests are required to be performed on the medical devices subject to sampling. The Group, therefore, is asked to provide the relevant technical documentation, including the previous testing protocols and the relative results. The test is performed in compliance with the procedure reported by the Manufacturer in the technical documentation and can be conducted: - At the Manufacturer s or critical Supplier s headquarters, directly by the personnel responsible under the supervision of the Audit Team, who shall also investigate the use of competent staff and measurement tools calibrated by accredited calibration centres and therefore with metrological traceability guarantee. - At the Kiwa Cermet Laboratory or with external laboratories qualified by Kiwa Cermet. In special cases, when tests show protocols not easily performed by laboratories, laboratories recommended by the Customer can be chosen, provided that the test is performed under the supervision of a Kiwa Cermet expert technician. At the end of the audit, the Lead Auditor gives a copy of the audit report to the Customer and files a copy of the recording of the tests carried out the day of the audit and compiled by the Manufacturer s and/or critical supplier s staff responsible, who was in charge of the performance of the tests. If the tests are carried out by an external laboratory, or the test results require longer times than the unannounced audit days, the report will be closed by the Lead Auditor only after the outcome of the tests and sent to the Customer together with the test reports from the external laboratory. If the customer requires it, a copy of the completed report can issued. The management of the results of the announced audit occurs according to the same method described in 4.5. If the manufacturer refuses to receive an unannounced audit, Kiwa Cermet shall reserve the right to assess the subsequent actions that may lead to the suspension or revocation of certification. The customer is promptly informed about the decisions taken. 5. SUSPENSION, REVOCATION, REDUCTION OF THE CERTIFICATION The Certification can be suspended, revoked or reduced. - At the Customer s request; - After a decision by Kiwa Cermet, in case of: o When there are more major non conformities; rev. 7 of Page 10 of 15

11 o Existence of serious reports from the market and/or Competent Authority; or failure to promptly notify Kiwa Cermet regarding actions, for whatever reason, the public authority and/or accidents, or legal proceedings; o Implementation of significant changes to the product or quality management system approved or covered by the certification without prior information to Kiwa Cermet; o Irregularities in payments of activities undertaken; o References to certification or use of the Kiwa Cermet trademark in such a manner as to deviate from the provisions of this regulation in 6; o Suspension/revocation of the CE certificate of the supplier OEM in the event of Own Brand Labelling (OBL); o Incorrect allocation or incorrect classification of the MDs; o Failure to adapt to the amended requirements of the regulations in the Kiwa Cermet certification system in case of amendment; o In the event of sentencing for facts concerning failure to comply with binding requirements pertaining to the product being certified; in this case, the agreement will be suspended in case of a sentence that has not become res judicata, while the agreement will be revoked for a sentence that has become res judicata. o More generally: failure by the customer of the contractual conditions (set out in this document, in Kiwa Cermet s general terms and conditions and in the financial quotation accepted by the Customer), the requirements for certification of the economic conditions agreed with Kiwa Cermet, or in case of change of the contractual terms and conditions implemented without the approval of Kiwa Cermet; Kiwa Cermet, based on the reasons that led to the suspension/revocation/reduction, reserves the right to: - Request the Customer to recall the products already on the market (including products in stock the volumes of which must be communicated to Kiwa Cermet by the Customer); - Allow the Customer to continue with the marketing of the products already made at the date of the suspension/revocation/reduction for a period of 6 months from the date of suspension/revocation/reduction, prior to receipt by the Customer of a communication signed by the Legal Representative specifying the number and identification of lots of products concerned; in said case Kiwa Cermet reserves the right to conduct an audit at the customer before granting the possibility to continue with marketing; said audit is charged to the Customer. The products not in stock at the date of certificate validity expiry may no longer show reference to the certification and be placed on the market. In case of suspension/revocation/reduction, Kiwa Cermet shall notify the customer in writing, communicating also the conditions that the customer must meet, and the time-frame for doing so. During the suspension period the customer loses the right to refer to the certification and use the CE marking and relative certificate, must stop using all advertising material that contains relative references and return, at the request of Kiwa Cermet, any certification documents. The conditions for the reinstatement of the certificate (including the necessary activities of the conformity assessment) shall be established by Kiwa Cermet according to the motivations that led to the suspension and based on the duration of the suspension. Except in exceptional cases (however approved by the Kiwa Cermet or by the Competent Authority), the period of suspension may not last longer than 6 months, otherwise the certification shall be revoked. In the event that the Customer fails to implement the actions indicated by Kiwa Cermet for the purpose of reinstatement the suspended certification, the latter shall be revoked or, where possible, its field of application shall be reduced. The reduction of the scope of application of the certification leads to the withdrawal of the old certificate and the issuing of a new certificate, specifying the type of product for which the certification is still valid. Following the certification revocation, the Customer loses the right to refer to the certification and use of the CE marking and the related certificate. The Customer can start the certification procedure again, by submitting a new application. The suspension, revocation and the possible reduction of the certificate are communicated by Kiwa Cermet to the Competent Authority with information on the reasons and medical devices covered by these measures. rev. 7 of Page 11 of 15

12 6. INCORRECT USE OF CERTIFICATION, THE CERTIFICATE AND CE MARKING It is considered incorrect use of the certification or certificate when a third party is misled, or led to misinterpret the nature, quality and origin of the device. In particular it must be clear that the certificate relates solely to the "product" certified. Partial copies of the certificate are not allowed. It is incorrect to use the CE marking when: - The marking is applied to devices not in conformity with the subject shown in the certificates or for which certificates were revoked/suspended. - The certificate has expired and has not been renewed; - For devices with certification application not yet submitted or refused; - When the Customer has not implemented the changes requested by Kiwa Cermet. If incorrect use of the certification, certificate or CE marking is detected, Kiwa Cermet shall notify the Competent Authority and revoke the Customer s right to affix the CE marking and use the certification. In severe cases (for e.g. unlawful marking) Kiwa Cermet shall also inform the Prosecutor's Office. 7. MANUFACTURER OBLIGATIONS (OR AUTHORIZED REPRESENTATIVE) 7.1. Manufacturer obligations (or Authorized Representative) for Annex II, V and VI of the Directive. - Provide Kiwa Cermet with all necessary information regarding the Manufacturer, products or categories of products covered by the certification/extension procedure and any possible outsourcing suppliers; - Inform Cermet Kiwa of all the places in which the device is manufactured, particularly if said places do not correspond to the Manufacturer s (or his Authorized Representative s) operational headquarters; - During offer acceptance, expressly declare not to have submitted the application for certification for the same device to another Notified Body; - Provide Kiwa Cermet with all the technical and system documentation during the first stage as well as after subsequent conformity assessments, - Respect and enforce the obligations under the Directive; - Ensure the registration/information procedures provided for by the Local Competent Authority; - Inform Kiwa Cermet concerning the periods when the certified device will not be manufactured; - Maintain product conformity with the essential requirements of the Directive; - Fulfil the obligations imposed by the quality system approved by Kiwa Cermet and ensure its proper and effective functioning. These obligations also include the systematic updating of the documentation in line with legislative updates, guidelines and the state of art of the reference sector; - Establish and implement a procedure for the changes that affect the products subject to certification or the approved quality management system, providing timely notification to Kiwa Cermet before implementation; - Undertake to establish a procedure for the management of claims and reports received from its customers and interested parties affecting the conformity of the certified devices, ensuring their proper registration, including the implementation of appropriate investigations and, where necessary, the adoption of corrective measures. - Establish and maintain a procedure for the evaluation of clinical data and after sales clinical follow-up undertaken or planned in relation to the device subject to certification, as provided in Annex X of the Directive. If no clinical investigation is undertaken, due justification must be provided; - Establish and maintain a systematic procedure to assess the experience gained from devices in the postproduction phase, including the provisions of Annex X of the Directive, as well as provide the appropriate means to apply the necessary corrective measures; - Notify the Competent Authority and Kiwa Cermet, as soon as it becomes aware of incidents that are by way of example provided below: rev. 7 of Page 12 of 15

13 Any malfunction or deterioration in the characteristics and/or performance, as well as any inadequacy in the instructions for use of a device that may cause or have caused death or severe deterioration of the patient's or a user s health; Any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point i), which led to the systematic withdrawal from the market by the manufacturer of the devices belonging to the same type. - Maintain the above obligations for all extensions to new products subject to certification by Kiwa Cermet; - In case of conformity assessment procedures in OBL 2, monitor the existence of the CE Marking certificate of the Original Equipment Manufacturer - OEM supplier, promptly informing Kiwa Cermet in the event of changes. - For all suppliers identified as critical (including OEM): establish a contractual requirement between the Customer and the supplier in such a way that access by Kiwa Cermet is granted to all critical suppliers sites and documents 3 or critical subcontractors 4 (also downstream of the supply chain where appropriate) where medical devices subject to certification are produced or processed, for periodic and unannounced audits; - For all critical suppliers (including OEM): The supplier must provide the Customer with all the technical and system documentation which is required to provide evidence of compliance with the essential requirements and the application of quality management system. If the supplier documentation is covered by industrial secrecy so that the supplier cannot supply it to the manufacturer, a supporting objective reason must be available, which shall be assessed by Kiwa Cermet with regard to the suitability of process trade secrets. Said documentation must be available for consultation during the audit. 7.2 Manufacturer Obligations (or the Authorized Representative) specific to Annex II of the Directive. Within the context of a device which includes an examination of paragraph 3.1 of annex II of the Directive, it must submit an application to Kiwa Cermet for examination of the product design file which will be manufactured; As part of a device that includes an examination of paragraph 3.1 of Annex II of the Directive, it should provide Kiwa Cermet with a description of the design, manufacture and performance of the product, in addition to the necessary documents contained in paragraph 3.2, letter c ) of Annex II of the Directive; Provide a statement to Kiwa Cermet specifying whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in paragraph 7.4 of annex I, or that attests whether tissues of animal origin referred to in Directive 2003/32/EC have or not been used in the production; Undertake to keep available to the competent Authorities and Kiwa Cermet, for a period of at least ten (10) years and, in the case of implantable devices at least fifteen (15) years from the date of manufacture of the last product: a) The EC Declaration of conformity; b) The documentation provided in paragraph 3.1, fourth indent (in particular the documents, data and records referred to in paragraph 3.2, second paragraph) of Annex II of the Directive; c) The adaptations provided in paragraph 3.4 of Annex II of the Directive; d) The documentation provided in paragraph 4.2 of Annex II of the Directive; e) The decisions and reports of the Notified Body referred to in paragraphs 3.3, 4.3, 4.4, 5.3 and 5.4 of Annex II of the Directive. 2 Own Brand Labelling (OBL) shall mean a Manufacturer of medical devices marketing in its own name an already CE marked device by an Original Equipment Manufacturer (OEM) 3 Crucial suppliers: the supplier of crucially important components or whole devices (critical raw material, finished products, primary packaging, crucial semi-finished products, etc.). 4 Critical subcontractors: suppliers in charge of processes that are essential in assuring conformity with the legal provisions (design, special or custom components, special processes, sw, tests and controls, etc.); rev. 7 of Page 13 of 15