Notified Body Status Achieved Under EC Directive 98/79/EC on In Vitro Diagnostic Medical Devices.
London – 1 February 2010 – SGS is pleased to announce that it has extended its medical device Notified Body status to include European Directive 98/79/EC on in vitro diagnostic (IVD) medical devices. SGS’s initial scope of designation as an in vitro diagnostic directive (IVDD) Notified Body includes all LIST B devices and Self-Test IVD devices. This scope will be further expanded to include all LIST A devices during the latter part of 2010.
“The expansion of our global portfolio of services to include IVDD 98/79/EC further strengthens our position as a leading Certification and Notified Body in the in vitro diagnostic device sector,” commented Sharon Williams, SGS Global IVD Certification Manager. “It allows SGS to offer CE Marking, ISO 13485, CMDCAS and JPAL certification to IVD medical device manufacturers, ensuring their devices perform as intended, are legal and gain access to markets in the minimum amount of time necessary,” she continued.
Ms. Williams, who joined SGS in April 2009 to become Global IVD Certification Manager, has over 18 years of experience in the IVD sector, working in both the industry and for a UK Notified Body where she was actively involved in the European level working groups on IVD Directive implementation and guidance.
Chris Jepson, SGS Global Manager for Medical Devices, added, “SGS appreciates the considerable IVD expertise Sharon has brought to the global team, which confirms our leading position as a provider of certification, audit and training services to the whole medical devices sector and the related pharmaceutical industry.”
Starting in March, SGS will arrange complimentary web seminars about the key requirements of IVD medical devices Directive 98/79/EC, registration available online. SGS has also launched public training courses on the subject, and the first session will take place on April 22, 2010 in the UK.
SGS has a global network of qualified medical device and pharmaceutical auditors able to provide auditing and training services from more than 40 countries. Trained IVDD auditors are in place in Europe, Asia and North and South America to support our already active IVD sector and further raise its profile to provide the services needed by this specialist group of manufacturers. This new status allows SGS to support those customers to meet their regulatory obligations with recognised certification across a range of regulatory schemes that are essential for marketing their products in global regions, including North America, the EU and Asia Pacific.
Background information on IVD Devices and Classification
In vitro diagnostic (IVD) medical devices are, in general terms, medical devices that are used to collect human samples to provide diagnostic information for a medical purpose. Under the European Directive 98/79/EC on in vitro diagnostic (IVD) medical devices, they are classified into List A (high risk devices), List B (moderate risk devices) and self test devices (as used by lay users). Any other IVD is considered to be a general IVD device. List A devices include the critical blood grouping devices for ABO, Rhesus and anti-Kell systems and IVD devices for the critical human infections of HIV 1/2, HTLV I/II and hepatitis B,C,D. List B devices include IVD devices for human infections of rubella, toxoplasmosis, CMV, chlamydia and devices for blood grouping systems anti-Duffy, anti-Kidd and irregular anti-erythrocytic antibodies. List B also includes devices for PKU disease, tissue grouping HLA DR, A, B, tumour marker PSA, devices including software for evaluating Trisomy 21 as well as self-testing devices for blood glucose.
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 59,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world. SGS offers IVD and medical device manufacturers, processors, contract manufacturers and distributors a range of medical devices services including certification, training and testing to help them navigate the complexities of the medical device market.
SGS has a global network of qualified auditors able to provide certification for the quality system standard ISO 13485:2003, directive 93/42/EEC and directive 98/79/EC. SGS training services provide training courses on ISO 13485, IVD Directive and Medical Devices Directive, delivering first class training based on our professional competency as a Notified Body and Certification Body.
For further information, please contact:
Outi Helena Maatta
1 place des Alpes
CH-1211 Geneva, Switzerland
t: +41 22 739 9161
m: +41 79 251 8218
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 67,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.