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Internationally Recognized Testing and Certification for Medical DevicesMDD, IVDD, AIMD, CMDCAS, PAL and FDA Third Party ServicesT U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2NOTE TO GIST : POCKET GOES HEREMarket Observation – WorldwideAre you looking for help with navigating the regulatory challenges of the future in order to participate effectively in the marketplace? With more than 300 locations in almost 50 countries, TUV Rheinland of North America Inc. with its affiliated offices has a global view of the ever changing requirements of the most important markets in the world. TÜV Rheinland Product Safety GmbH as a “Notified Body” for all medical devices, including active implantable medical devices and in-vitro diagnostic medical devices, TÜV is the partner you are looking for.TÜV can offer certification for products and quality management systems for medical device manufacturers doing business in the international marketplace.Benefits• TÜV’s global presence means a quick return on investment• One-stop shopping through a comprehensive range of services• Customer satisfaction resulting in cost reduction• TUVdotCOM certificate reference databaseT U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2Perfectly PositionedCE Certification of Medical Devices• Active and non-active medical devices• Active implantable medical devices• In-vitro diagnostic medical devicesComprehensive Service• International approval of your medical devices • EMC (Electromagnetic Compatibility)• CB scheme for worldwide approvals• Certification in accordance with EN ISO 13485 (and EN ISO 9001)• Certification of QM systems for processing medical devices in risk categories up to and including C-critical• GM Mark (approved medical device) for visible added value• Medical aids• TUVdotCOM Certificate reference databaseT U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2Proven Steps on the Way to CE MarkingDirectives affecting medical device manufacturers in Europe:• 93/42/EEC on medical devices (MDD)• 90/385/EEC on active implantable medical devices (AIMD)• 98/79/EG on in-vitro diagnostic medical devicesManufacturers must comply with the medical device directives in order to sell into the European marketplace. TUV Rheinland of North America with the Notified Bodies can help you carry out your conformity assessment procedure for CE Marking as well as assist you to acquire worldwide approval of your medical devices. TÜV offers a comprehensive range of services.Steps to acquiring the CE marking include:1. Definition of the medical device and intended useAs a manufacturer, you determine theintended use of your device. This results in a decision as to which directive is applicable to your medical device (MDD, AIMD or IVDD).2. Classification of the medical deviceIn the MDD, medical devices are classified in accordance with the regula-tions in Annex IX. The AIMD does not provide for any classification. The IVDD distinguishes between products for self-testing, for performance evaluation, Lists A and B and products which do not fall into any of the categories named.3. Determination of the suitable procedure for conformity assessmentDepending on the classification ofthe product, a “Notified Body” isrequired, which, for example, you willentrust with carrying out an EC type examination, with assessing a designdossier and/or with auditing your QMsystem. AIMD products always requirethe involvement of a “Notified Body”.4. Technical documentationThe manufacturer must preparetechnical documentation for everytype of medical device, whichessentially consists of the following:description of the device, designdocuments, the standards applied anda description of the solutions chosento meet the essential requirements,risk analysis, test reports, clinicalevaluation, labeling and instructionsfor use, and additionally for steriledevice descriptions of the sterilizationprocedures used and the validationcertificates.Medical devices must fulfill the applicableessential requirements listed inAnnex I of the respective directive.T U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2Proof must be provided that the safety requirements have been met and that the technical services have been rendered. An assessment procedure also must be provided. The medical effectiveness must be proven through a clinical assessment. The manufacturer is free to choose how he will provide proof that the essential requirements have been met.As a test body for medical devices, TÜV Rheinland can conduct necessary tests, such as safety, functional and biocompatibility tests, which can then be used as acknowledged proof for your technical documentation.5. EC type examination or examinationof the design of the productFor all AIMD, MDD Class III and IVDD List A products, the manufacturer must decide between the EC type examina-tion procedure and the examination of the product design documentation (design dossier). In this process, TUV Rheinland of North America with the Notified Body can test either the product or the design dossier. After successful examination, the certification body of TÜV Rheinland issues an approval in accordance with the directive.6. Implementation of the conformityassessment procedureManufacturers of medical devices generally choose to audit their quality management systems. The auditors assess the documentation of the QM system prior to the audit and verify the application of the written procedures during the audit at the company location. The duration of the audit and the number of auditors required will depend on the size of the company and the number of different products covered. This information (size and number of products) is provided to TÜV Rheinland in each company’s individual quotation. After the audit, you will receive a written report with the audit results.As an alternative to the audit, a manufacturer can choose the EC verification procedure (sampling or individual testing) in accordance with Annex IV (MDD) or Annex VI (IVDD). Upon successful completion of the conformity assessment procedure, the Notified Body will issue an approval for the CE Marking of your devices.T U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2Faster Market AccessTUV Rheinland of North America can help you get to market faster (The fol-lowing steps apply to medical devices in accordance with the AIMD, MDD, IVDD directives).1. Establishing ContactFirst, TUV Rheinland of North America with the Notified Body will introduce you to the range of services of the Notified Body and capabilities and then get to know you, your company and your products. Your needs and further procedures are then determined together. Early establishment of communication, in some cases even in the product development phase, will allow for better coordination of the time schedule for the market launch of your product.2. QuotationTUV Rheinland of North America will prepare a quotation for you that covers the requested services in the CE Marking process (QM audit, product testing, examination of the technical documenta-tion, etc.).3. OrderAfter receipt of the order, TÜV Rheinland will respond to your questions quickly and coordinate the handling of your project.4. Technical DocumentationPrior to product testing or an audit, selected documents from the technical documentation will be checked for plausibility and for conformity with the requirements of the directive.5. All AIMD, MDD Class III and IVDD List A ProductsFor examination of the design dossier or EC type-examination: Submit the documentation on the product design (design dossier) to TÜV Rheinland. It will be checked for completeness and plausibility, or the product and the associated documentation will be tested. A report on the test results is then issued. If the assessment is positive, you will receive the following certificates:• MDD: Annex II.4 or Annex III• AIMD: Annex II.4• IVDD: Annex IV.4 or Annex V for List A• Annex III.6 for IVDD for self-testing6. Voluntary Pre-AuditTÜV Rheinland will base the scope of the pre-audit on your wishes. Upon completion of the pre-audit, you will receive a report that includes recom-mendations for improvements.7. Review of the QM DocumentationThe QM documents, such as the Quality Management Manual and any relevant procedures, will be assessed by TÜV Rheinland prior to the audit, and a report will be issued to you. 8. Certification AuditPrior to the certification audit, you will receive the audit plan created with and approved by you. During the audit, your company’s operations will be examined and evaluated to ensure that the requirements of the applicable directive and the relevant standards are fulfilled. During the audit process, TÜV Rheinland will pay particular attention to assess the conformity of your products with the essential requirements and the team of auditors will always include at least one expert on your product category. All relevant production sites are included in the scope of the audit. Upon completion of the certification audit, a detailed report will be issued, including recommendations for improvement. 9. Certificate/ApprovalIf the audit result is positive, you will receive an approval for the respective conformity assessment procedure. In follow up, surveillance audits will be performed every twelve months and a recertification audit will be conducted after five years. 10. Declaration of ConformityYou will then be permitted to issue the declaration of conformity for your medical devices, to provide them with the CE Mark including the identification number of the “Notified Body” and to place your T U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2Medical deviceClassification of the deviceClass IIa Class IIb Class III Class IIaClass IClass Is(sterile)Class Im(with measuring function)Annex VII Annex VII Annex III Annex IIEG typeexamination certificateClass III:additional EC design-examination certificateAnnex V Annex IV Annex VI(not for Class III)ApprovalQM certificateApprovalQM certificateDeclaration of Conformity by the “Notified Body”ApprovalQM certificateDeclaration of Conformity by the manufacturer Essential requirements met0197Modular System for Medical Device CertificationT U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2Complete Service Puts You a Step Ahead• EMC• CB Scheme• EN ISO 13485 (and EN ISO 9001)• CMDCAS• Japanese (PAL) Pharmaceutical Affairs Law• Processing medical devices• GM Mark (approved medical device)• Medical aidsOn your way to increased safety and quality, TÜV Rheinland offers an array of services in addition to CE marking and international product certification.EMC – Electromagnetic CompatibilityAnyone who wants to successfully market medical devices worldwide must comply with the relevant EMC standards. TÜV Rheinland carries out these tests in fully equipped test laboratories with absorber halls or in outdoor measuring places. Numerous measurements can also be made on a mobile basis at short notice on your premises. With “Competent Body” accreditation and FCC (Federal Communications Commission) listing, TÜV Rheinland is authorized to carry out all European and internationally required examinations.CB Scheme – Worldwide ApprovalWould you like worldwide approval of your devices? A single test and certifica-tion procedure may suffice as a basis for acquiring national test marks for many countries worldwide and multiple tests may not be required. The national test marks desired can be issued quickly and without problems on the basis of the CB certificate, saving time and money. As a National Certification Body, we have been associated with the CB procedure of IECEE for many years. Even in many other countries without official members, the CB procedure serves as the basis for national certifications (in IECEE), the CB Scheme serves as the basis for national certifications. Certification in Accordance withEN ISO 13485 (and EN ISO 9001)This international standard for quality management systems for companies in the field of medical devices defines the requirements for QM systems for the design and development, production, customer care and installation of medical devices. It covers fundamental GMP (Good Manufacturing Practice) principles, which normally apply during the manufacture of medical devices.CMDCAS – Canadian Medical Device Conformity Assessment SystemCompanies that manufacture and/or sell medical devices in Canada must conform to CMDCAS, the purpose of Essential requirements metT U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2which is to ensure that the companies are actually complying with the quality systems requirements of the Medical Device Regulations. All medical device companies that submit an application for a Class II, III or IV medical device must also submit a valid quality system certificate issued by a CMDCAS recog-nized registrar, such as TUV Rheinland of North America.Japanese (PAL) PharmaceuticalAffairs LawThe Pharmaceutical Affairs Law establishes regulations necessary for the manufacturing and distribution of medical devices and pharmaceutical products in Japan. TÜV Rheinland can help you to navigate these require-ments and understand established methods of both manufacturing control and quality in compliance with Japanese Good Manufacturing Practice (GMP).FDA Third Party Services As an Accredited Person (AP) TÜV Rheinland is authorized by the U.S. Food and Drug Administration (FDA) to perform Third Party Reviews and Third Party Inspections. Under the Third Party Review program TÜV Rheinland is authorized to conduct the primary review of 510(k)’s for eligible devices. TÜV Rheinland conducts the primary review of the 510(k), then forwards its review, recommendation, and the 510(k) to FDA. By law, FDA must issue a final determination within 30 days after receiving the recommenda-tion of an Accredited Person. 510(k) submitters who do not wish to use an Accredited Person may submit their 510(k)’s directly to FDA.Under the Third Party Inspection Program, eligible manufacturers of class II or class III medical devices may elect to have third parties conduct their inspec-tions against the U.S. Quality System Regulations instead of the FDA. The intention of the program is to reduce the burden of multiple inspections on manufacturers.GM Mark – For Visibly Added ValueThe GM (approved medical device) Mark is a comprehensive statement on quality and safety of a medical device issued by a neutral, independent test institute. Use this Mark to convince your customers that you far exceed the minimum required standard needed to guarantee the safety and quality of your products.Medical AidsTÜV Rheinland offers a wide range of services for medical aids, such as usability tests or a compliance check with the technical requirements in the official register of medical aids. T U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2Worldwide Market PresenceTUVdotCOM Service:• New global market opportunities • Support for buying decision of buyers, traders and consumers • Tool to differentiate you from your competitors• Communications platform for tested and certified performances • Non-stop full service – 7 days, 24 hours Anyone can advertise. But having the quality statements that are made about your product confirmed by a recognized, independent third party, (such as TÜV Rheinland), enables you to improve your advertising. With TÜV’s TUVdotCOM service, a non-stop, full-service communi-cations platform, we offer you a special sales and marketing tool. On the TUVdotCOM website, you and your customers can use your individual ID number to get direct information on the quality statements about your product. See for yourself. Visit www.tuv.com and try out TUVdotCOM.T U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2North American Headquarters12 Commerce Road, Newtown, CT 06470USA: Austin, Boston, Chicago, Detroit, Portland, Raleigh, San Diego & San FranciscoCanada - MexicoFor more information on internationally recognized tests and certifications for medical devices, please contact TUV at:1-TUV-RHEINLAND(1-888-743-4652)Service Beyond the MarkT U V R h e i n l a n d o f N o r t h A m e r i c a • 1 - T U V - R h e i n l a n d • 1 - 8 8 8 - 7 4 3 - 4 6 5 2