UL customers have direct access to Notified Body technical experts to help you understand the transition.
The new IVD and EU regulations were published in May 2017. There will be a 5-year transition period and during the transition, manufacturers can apply the IVD Directive or the IVD Regulation. After the transition period, all products placed on the market must meet the regulation or be taken off the market.
The IVDR moves from a list based regulatory structure to a risk-based classification system, based on the GHTF. This means that now, the majority of IVDs are required to have Notified Body approvals, many of which were under self-declaration in the past.
The organisation GHTF, a partnership between regulatory authorities and regulated industry, has now been permanently replaced by The International Medical Device Regulators Forum (IMDRF), who continue the work of the Global Harmonization Task Force.
UL has experts based throughout Europe, and UL-UK is a Notified Body under MHRA, (number 0843) with full-time technical file reviewers and auditors located around the world. UL customers have direct access to Notified Body technical experts to help them stay on the right path.
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