IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

Issue link: http://dc.cn.ubm-us.com/i/92152

Contents of this Issue

Navigation

Page 32 of 43

1. principle classifi cation of in vitro diagnostic medical devices;3 2. labeling of medical devices;4 3. Summary Technical Documentation for Demonstrat- ing Conformity to the Essential Principles of Safety and Performance of Medical Devices;5 4. Principles of Conformity Assessment for In vitro Diagnostic Medical Devices6 Of particular interest to the OEM business is the GHTF standard GHTF/SG1/N011: 2008 of the Sum- mary Technical Documentation. Th e OEM must generate technical documentation, the types of which are addressed in a highlighted section in Table II. Th e required content is relatively generic from a global point of view; however, spe- cifi c requirements related to the national medical device law of a given country need to be considered, as well. It's the PLM's responsibility to prepare the technical documentation of the customized lateral fl ow reader. But given the OEM's knowledge and experience, it must sup- port the PLM by preparing the documentation. However, the technical documentation requires information about the manufacturer, which includes the OEM's protected IP. Th erefore, the OEM prepares a detailed version of the technical documentation that contains this sensitive infor- mation. To allow government overview, a quality plan is implemented as described above. Th e modular approach to customization of IVD instru- ments is benefi cial to the PLM from the regulatory point of view. Apart from fl uorescence detectors, the lateral fl ow reader hardware and the main parts of the fi rmware are generic; the corresponding technical documentation sections for the hardware and fi rmware are also generic, including design and manufacturing information, essential principles checklist, risk analysis, control summary, and product verifi cation and validation. Th e fi rmware's docu- mentation covers the European Safety Class C and FDA's High Level of Concern, allowing the PLM to use the cus- tomized reader for even the highest safety class rapid tests. Th e advantage of this modular approach is that only the GUI, which represents the most important customized part of the instrument, needs to be introduced into the techni- cal documentation individually and PLM-wise. While the OEM exclusively focuses on the verifi cation description and the GUI validation processes, the PLM must address aspects around human factors engineering of the GUI and perform a formal risk analysis. 5. Essential Principles of Safety and Performance of Medical Devices7 References 1. I Macfarlane, F Davis, "Building blocks for the point-of-care boom," IVD Technology, January 2002. 3. Global Harmonization Task Force, "Principles of In vitro Diagnostic Medi- ivdtechnology.com 2. ZLG/EK-Med Answers and Resolutions, "Conformity Assessment – Certifi - cation of OEM Devices," 2007. Available online at http://www.tuvps.co.uk/ uploads/images/1281516789545136220477/ZLG%20EKmed_309_0607_ B16EN%20Certifi cation%20of%20OEM%20Devices.pdf. IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 33 4. Global Harmonization Task Force, "Labeling for Medical Devices," SG1- N43: 2005. cal Devices Classifi cation," SG1-N45: 2008. 5. Global Harmonization Task Force, "Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In vitro Diagnostic Medical Devices," SG1- N63: 2011. 6. Global Harmonization Task Force, "Principles of Conformity Assessment for In vitro Diagnostic Medical Devices," SG1-N46: 2008. 7. Global Harmonization Task Force, "Essential Principles of Safety & Per- formance of Medical Devices," SG1-N41: 2005. IVD Bernhard Gerstenecker, PhD, is senior scientist, head of the application laboratory, and respon- sible for market development PON instrumentation at Qiagen. He can be reached at bernhard. gerstenecker@qiagen.com. Michael Doumanas (MBA) is associate director strategic alliances & OEM PON global sales at Qiagen. He can be reached at michael. doumanas@qiagen.com. Klaus Haberstroh is senior director and head of PON instrumentation at Qiagen. He can be reached at klaus.haberstroh@qiagen.com. V i s i t u s a t M e d i c a : b o o t h 1 F 3 8 Now al so avaiabl l e wi th stri p devi ce !

Articles in this issue

Links on this page

Archives of this issue

view archives of IVDT_In Vitro Diagnostics Technology - IVD Technology, November/December 2012