In-Vitro Diagnostic Directive (IVDD) and IVDD Technical File Preparation Workshop. 3-4 July 2014 TÜV SÜD

Transcription

1 In-Vitro Diagnostic Directive (IVDD) and IVDD Technical File Preparation Workshop 3-4 July 2014 TÜV SÜD

2 Introduction The In-Vitro Diagnostic Directive (IVDD) 98/79/EC applies to all In-Vitro Diagnostic medical devices (IVDs) sold in the European Economic Area (EEA) regardless of where they are designed and manufactured. The Directive was introduced in the later part of 1998 and its compliance became mandatory on December 7, It addresses the safety, quality and performance of IVD medical devices and its objective is to ensure that IVD medical devices do not compromise the health and safety of patients, users and third parties and attain the performance levels specified by the manufacturer. The preparation and maintenance of Technical Documentation forms a fundamental step in the path toward meeting the IVDD requirements. Technical Documentation is intended to provide information on the design, manufacture, and operation of the product. New Approach directives oblige manufacturers to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. Though the requirement and processes involved in preparing a proper technical documentation is not very well defined in the IVDD, yet it forms one of the most critical steps toward applying for the CE mark on an IVD medical device. Through this training workshop, participants would expect to acquire information on IVDD and how to prepare a proper technical documentation that meets the requirements of IVDD.

3 About the Trainer Mr. Chenchuan Weng, Supervisor IVD, TÜV SÜD Certification and Testing (China) Co., Ltd. Mr. Weng is a qualified IVDD Technical File Reviewer and has 6 years R&D experience for HIV (1+2) antibody ELISA kit, HCV antibody ELISA kit and Syphilis antibody ELISA kit in Chinese IVD reagent manufacturer. In addition, he has 10 years of audit and assessment experience in notified body TÜV SÜD Product Service GmbH. He is an authorized auditor for ISO 13485, ISO 9001, IVDD 98/79/EC, MDD 93/42/EEC, J-GMP and CMDCAS. He has audited in more than 60 IVD manufacturers in China, Chinese Taiwan, USA, Korea and India. Who Should Attend Regulatory and non-regulatory staff in medical device companies including distributors, governmental authorities, health care providers, physicians, academicians, consultants, laboratory managers and members of Notified Bodies and test houses are welcome to join. Training Fee a. Early bird discount fee Workshop fee of S$1,200 per person (excluding 7% GST) if registration and /or payment is received latest by 6 June b. Normal registration fee Workshop fee of S$1,300 per person (excluding 7% GST) if registration and/or payment is received after 6 June c. Group discount fee Workshop fee of S$1,100 per person (excluding 7% GST) for at least 5 participants from the same organization to register before 6 June Enquiries Mr. Caleb Ng at DID: , Fax: , caleb.ng@tuv-sud-psb.sg Payment Fax or scanned copy of payment receipt together with registration form to guarantee your seat, or In Cheque / Cash must be made (Prior to commencement*), payable to TÜV SÜD PSB Pte Ltd is required upon registration and must be received prior to the event to guarantee your seats. Refunds and cancellations are allowed if written notice is received 14 days prior to the date of the event. No refunds are allowed thereafter. If the registered candidate is unable to attend the seminar, please inform us in writing of the replacement candidate. The final decision will be at the discretion of the management. Substitution is encouraged and permitted when notified.

4 Programme Schedule In-Vitro Diagnostic Directive (IVDD) and IVDD Technical File Preparation Workshop on 3-4 July 2014 Time Topic Day 1 Topic Day am Registration Registration 9:00 am Background of CE mark and Directive 98/79/EC Detailed requirements of CE technical file and EN standard 10:00 am Coffee Break & Networking am Product Classification & Conformity Assessment Route Con t with Detailed requirements of CE technical file and EN standard 11:00 am Certification Process Assessment 12:00 pm Lunch & Networking 1:30 pm Cont with Certification Process Discussion on Assessment Results 3:00 pm Coffee Break & Networking 3:30 pm Certification Maintenance Q & A 5.00 pm End of Programme All information is accurate at the time of printing. TÜV SÜD PSB reserves the right to make changes to the programmes and Trainer(s) due to unforseen circumstances.

5 In-Vitro Diagnostic Directive (IVDD) and IVDD Technical File Preparation Workshop on 3-4 July Registration Form Complete the application form below and to Ms. Doreen Yeo by 23 June Tel: / Fax: / doreen.yeo@tuv-sud-psb.sg Application Form: Company Name Number of Participants Company Address Telephone (Office): HP: Fax: Venue: