UKABs carry out medical device conformity assessments under the UKCA scheme. The scheme allows manufacturers to market their products in the UK. TÜV SÜD’s UKAB designation will help ease market pressure, at a time when industry is concerned by the limited capacity to conduct UKCA medical device conformity assessments within specified government deadlines. TÜV SÜD’s UKAB accreditation also offers medical device manufacturers the chance to gain UKCA and CE certification simultaneously which can reduce costs and time to market across Europe for new products.
Monisha Phillips, Head of UK Medical and Health Services (MHS) Certification Body at TÜV SÜD, said: “Extending our designation scope to include active implantable medical devices mirrors TÜV SÜD Germany’s EU Notified Body scope and will allow our active implantable medical devices clients to benefit from our full support for EU and UK market access, so they can optimise efficiencies.”
Full details of the scope of designation can be accessed here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1178444/TUV_SUD_BABT_Unlimited_Medical_Devices_Scope.pdf
Further information:
Founded in 1866 as a steam boiler inspection association, the TÜV SÜD Group has evolved into a global enterprise. More than 26,000 employees work at over 1.000 locations in about 50 countries to continually improve technology, systems and expertise. They contribute significantly to making technical innovations such as Industry 4.0, autono-mous driving and renewable energy safe and reliable. tuvsud.com
TÜV SÜD AG
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http://www.tuvsud.com/de
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E-Mail: Dirk.Moser-Delarami@tuev-sued.de
