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Ben Kemp

HighlightsHighlights Archive

EU publishes IVDR transitional period extensions into law

The amending regulation which extends the transitional provisions of the IVD Regulation has become EU law and comes into force from today. This is immediately applicable in all member states, and will allow for further preparation time for companies depending on device classification. Regulation (EU) 2022/112 extends the IVDR transitional periods, allowing most devices with their EC Declaration of Conformity…
Ben Kemp
January 28, 2022
External Affairs Working PartyExternal Affairs Working Party Archive

External Affairs WP Minutes -21 January 2022

The BIVDA External Affairs Working Party held its latest meeting on Friday 21 January. The group heard updates on BIVDA activities regarding COVID test approvals, the BIVDA/EUCOPE Early Cancer Diagnostics Roundtable, consultation work and discussions around vaccination requirements on health sites. You can find the minutes from today’s External Affairs Working Party meeting here.
Ben Kemp
January 28, 2022
Export Working PartyExport Working Party Archive

UK-Israel Free Trade Agreement: Pre-Consultation Questions for Members

In November 2021, the PM announced that the UK would begin talks with Israel in 2022 on an enhanced and improved UK-Israel Free Trade Agreement. The Department for International Trade are planning to open the Call for Input (CFI) shortly, and this will likely remain open for eight weeks. They strongly encourage input from a wide variety of businesses whose…
Ben Kemp
January 21, 2022
COVID-19 TaskforceCOVID-19 Taskforce Archive

Medical Device Coordination Group (MDCG) issues note to COVID IVD Manufacturers

The Medical Device Coordination Group (MDCG) has endorsed a notice addressed to manufacturers of in vitro diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection that are based in countries outside the EU or the EEA and that place or intend to place the abovementioned devices on the EU market. The notice is…
Ben Kemp
January 14, 2022
Export Working PartyExport Working Party Archive

Talks on a UK-India Free Trade Agreement to commence next week

On Thursday 13 January, the United Kingdom launched negotiation talks with India on an ambitious new Free Trade Agreement (FTA). An event was held in New Delhi to announce the opening of the talks process, attended by the UK’s International Trade Secretary Anne-Marie Trevelyan. Ms Trevelyan is due to meet with her counterpart, Indian minister of Commerce and Industry Piyush…
Ben Kemp
January 13, 2022
Export Working PartyExport Working Party Archive

Temporary relaxation of the enforcement of the retained EU drivers’ hours rules

The Department for Transport has, pursuant to Article 14(2) of the retained EU Drivers’ Hours Regulation, gained the approval of the Secretary of State for Transport to temporarily relax the enforcement of the Regulation in England, Scotland and Wales, from 12 January until 10 February 2022. The temporary relaxation of the rules reflects the urgent situation arising from the impacts…
Ben Kemp
January 13, 2022
European AffairsEuropean Affairs Archive

European Affairs Updates – 14 January

British Manufacturers issue warning over spiralling costs due to Brexit changes in 2022 UK manufacturing firms are sounding the alarm over the effect of Brexit changes in 2022 leading to soaring costs. Companies are expecting further customs delays and red tape (including rule-of-origin forms and customs declarations) as a result of Brexit to be among the biggest challenges facing their…
Ben Kemp
January 13, 2022
HighlightsHighlights Archive

Blood test could diagnose cancer in people with nonspecific symptoms

Scientists have created a blood test which is highly effective in detecting cancer in those with worrying symptoms, such as unexplained weight loss and fatigue. If the test is validated, it could significantly improve survival rates by diagnosing cancer much earlier and thus allowing patients to receive more effective treatment. The test can also show whether the cancer has spread.…
Ben Kemp
January 7, 2022
HighlightsHighlights Archive

UKHSA Chief Executive Dr Jenny Harries honoured with Damehood

Dr Jenny Harries, Chief Executive of UKHSA, has been made a Dame in the Queen’s New Year honours list for her outstanding contribution to public health. Some of her colleagues have also been honoured by Her Majesty, including Jonathan Turner, Head of Scientific and Technical Services, who has been awarded an MBE and Professor Kevin Fenton, London Regional Director of…
Ben Kemp
January 7, 2022
HighlightsHighlights Archive

Confirmatory PCR tests to be temporarily suspended for positive lateral flow test results

UKHSA has announced that from 11 January in England, people who receive positive lateral flow device test results for COVID-19 will be required to self-isolate immediately and won’t be required to take a confirmatory PCR test. This is a temporary measure while COVID-19 rates remain high across the UK. Whilst levels of COVID-19 are high, most people with positive lateral…
Ben Kemp
January 7, 2022
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