SGS is pleased to announce that it has extended its Notified Body scope under the European Directive 98/79/EC on in vitro diagnostic (IVD) medical devices to include high risk LIST A products, giving a full designation scope. SGS initially gained designation as IVD medical device Directive (IVDD) Notified Body 0120 in 2010, with a scope that included all LIST B and Self-Test IVD devices. This extension to the designated scope means that SGS Notified Body can additionally provide certification services for all LIST A devices. SGS now has a global comprehensive scope for all manufacturers of IVD devices.
Sharon Williams, SGS Global IVD Certification Manager commented that “This further expansion of our Notified Body services for IVDD 98/79/EC demonstrates our commitment to providing the widest possible range of certification services to our clients in the IVD industry sector, backed by a global network of qualified medical device auditors and offices, strengthening our position as a World Class Certification and Notified Body". She also commented, “SGS can offer its IVD medical device clients a full service across CE Marking, ISO 13485, CMDCAS, JPAL and other certification, supporting manufacturers to ensure their devices reach the market as quickly and smoothly as possible, with regulatory certification.”
Ms. Williams, who joined SGS in April 2009 to become Global IVD Certification Manager, has nearly 20 years of experience in the IVD sector, working in both industry and for UK Notified Bodies, and she is actively involved in the European level working groups on IVD Directive implementation and guidance.
Expansion in the Fastest Growing Healthcare Sector
IVD medical devices are the fastest growing sector in the healthcare landscape. The IVD Directive 98/79/EC defines the requirements for CE Marking and EU market access for these products which test human samples, providing diagnostic information for individual patients as well as ensuring a safe blood supply for hospitals. SGS will be working in partnership with Europe’s leading independent IVD testing laboratory, the Paul-Ehrlich-Institut laboratory in Germany, to provide testing services for LIST A devices for the verification of manufactured product.
Chris Jepson, SGS Global Manager- Medical Devices, added, “This represents another major step forward for SGS and our IVD clients worldwide. With a full current directive scope and extensive expertise SGS is also prepared for the increased range of Notified Body certification needed for future revisions to Directive 98/79/EC. As a provider of certification, audit and training services to the whole medical devices sector, SGS can help IVD medical device manufacturers to confirm their devices perform as intended, are legal and gain access to EU and Global markets in the minimum amount of time.”
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 provide the full service profile needed by this specialist sector of manufacturers. SGS can support these customers to meet their regulatory obligations with recognized 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.
About 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 64,000 employees, SGS operates a network of over 1,250 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.
Learn more about SGS Medical Devices.
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The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.