Please see below a Q and A in reference to a UKRP. Is it possible to transfer to a UK agent? If transfer is possible, will the procedures and registered medical devices be transferred as well? If transfer is not possible, should the medical device be registered under the name of a new agent? Only one UKRP is permitted for…
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Dear members, BIVDA held a joint in-person workshop with the MHRA on the future IVD Roadmap. This took place on 10 February at the MHRA offices. The aims of this were to understand: The IVD ecosystem The gaps in the landscape MHRA’s role in this The needs for pre-market support The barriers and enablers for market access The workshop was…
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On 29 December, the UK Health Security Agency published their statutory review of the CTDA process. The CTDA process was introduced to ensure that antigen and molecular Covid-19 tests were assessed for performance before being put into the UK market, intending to increase the quality of UK tests. The overarching theme of the review is summarised: “It is clear that…
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The UKCA sub-group met on 29 November for the first time in over a year. This group had been paused due to insufficient information on UKCA in recent time but has now been restarted as we are expecting discussions around UKCA and the future requirements to increase substantially. The meeting itself had a fantastic turnout and a lot of interesting…
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Each year, BIVDA organises a Christmas dinner for members of the Regulatory Affairs Working Party, as well as a charity appeal. This years charity is FareShare, who redistribute surplus food to charities that turn it into meals and provide much needed support to communities in need. Please donate here. The Christmas lunch will be held at Ponti's restaurant which is located just off Oxford…
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