Notified Body SGS Expands into IVD Certification

SGS has extended its medical device Notified Body status to include Directive 98/79/EC for in vitro diagnostic (IVD) medical devices. The company’s initial scope of designation as an IVD Directive 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.

This move “… 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,” commented Sharon Williams, SGS Global IVD Certification Manager.

Ms Williams, who joined the company in April 2009 to take up that appointment, has more than 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.

Starting in March, SGS will provide complimentary web seminars about the key requirements of IVD medical device Directive 98/79/EC, registration is available online at www.sgs.com/webinars.

The company has also launched public training courses on the subject and the first session will take place on 22 April 2010 in the UK (www.uk.sgs.com/training).

SGS has a global network of qualified medical device and pharmaceutical auditors able to provide auditing and training services from more than 40 countries.

Tags: IVD Notified Body, SGS