A new ‘UK Responsible Person Directory’ page will be launched on 1 December by BIVDA, with support from member company IVDeology. The directory will be of use to those looking to have their UKRP status made known to those looking to place a devices on the UK market.
The UKRP Directory is available free of charge to BIVDA member companies who wish to have their details made public on the page, there is a nominal fee of £199 plus VAT for non-BIVDA member companies to be featured on the list.
The new role is similar to the existing responsibilities of the EU Authorised Representative (AR) that is currently required for non-EU Legal Manufacturers within to place device onto the market in the EU under the IVD Directive. The use of the EU AR will continue under the new IVD Regulation from May 2022. The UKRP is responsible for registering devices with the MHRA, and acts as the first point of contact for MHRA, and customers within the UK market.
Please contact Michael ahead of the web-page’s launch for more information on the page and how to appear on it.