Ben Kemp – Page 311 – BIVDA Newsletter

European Commission publishes updated ‘Blue Guide’

The European Commission has published the new ‘Blue Guide on the implementation of the product rules 2022’. This was first published in 2000 and has been updated in 2014 and 2016. Given the New Legislative Framework which has been implemented in the EU, it was appropriate for a further update to take place. This latest update adds mention of (EU)…

Ben KempJuly 1, 2022

Membership News Membership News Archive

CTDA Update

Recognising that a significant amount of the discussion is commercial and in confidence, we are able to share with members some positive outcomes. Firstly, there is recognition that the questions from the webinar have not yet been answered, they have confirmed that all the operational questions are answered internally and they are waiting for a couple more responses back from…

Ben KempJuly 1, 2022

Membership News Membership News Archive

BIVDA contributes to industry panel at the MediWales Connects conference 2022

MediWales Connects was held on 29 June in Cardiff, with fantastic turn out from industry and the healthcare sector. Sessions covered the changes taking place within NHS Wales and talks from key stakeholders on important updates for the sector. Ashleigh spoke on the topic of IVD Regulation and how this is likely to impact stakeholders, including providing some detail on…

Ben KempJuly 1, 2022

Membership News Membership News Archive

MHRA has published their response to the ‘future regulation of medical devices in the UK’ consultation

On 26 June, MHRA published their formal response to the consultation on the future regulation of medical devices in the United Kingdom. This has been eagerly anticipated and gives a lot of detail on what can be expected for the new regulatory framework. The document totals 155 pages and has 16 chapters. An executive summary drafted by BIVDA can be…

Ben KempJuly 1, 2022

Procurement Working Party Procurement Working Party Archive

Procurement Bill – Resources on the new legislation

As of 24 June, The Procurement Bill has passed its second reading in the House of Lords and will begin Committee Stage on 4th July. It was first introduced on 11 May 2022. You can check the latest on the passage of the Bill, including the current list of amendments tabled, on the Parliamentary website. The Procurement Bill team have…

Ben KempJune 24, 2022

Consultations

Draft HIV action plan for Wales 2022 to 2026

The Welsh Government is seeking your views on their draft HIV action plan for Wales 2022 to 2026. The action plan itself can be viewed here. You can either submit your feedback online here or you can download the response form (which can be found on this page) and send it to healthprotection@gov.wales. Your comments must be submitted by 14…

Ben KempJune 17, 2022

Highlights Highlights Archive

Pharmacies to spot cancers to support NHS’s early diagnosis targets

Funding will be provided to pharmacies to identify cancer in patients, the NHS Chief Executive Amanda Pritchard has announced. This is part of an NHS drive to catch tumours earlier when they are easier to treat and improve diagnosis and survival figures. Part of the NHS Long Term Plan committed to increasing the number of cancers caught early from half…

Ben KempJune 17, 2022

Export Working Party

NHS Confederation – Call for information on Swiss-UK FTA consultation

Doris-Ann and Michael met with NHS Confederation's European Office team, Rosie Richards and Kate Ling, this week and discussed the ongoing Swiss-UK free-trade agreement consultation process. Please find the call for input page on Gov.uk here. The DIT is especially asking for views about Which areas do you want the UK government to prioritise in trade talks with Switzerland when…

Ben KempJune 10, 2022

Membership News Membership News Archive

Update on MHRA restructuring and BIVDA engagement

As many members will know, MHRA has been undergoing a re-structuring to bring all elements of healthcare regulation together. But meanwhile they have lost critical IVD expertise with recent moves by Graeme Tonbridge, Mike Messenger and Camilla Fleetcroft. This week however Dr Penny Wilson, who will be familiar to many of you, took up position as a Deputy Director and…

Ben KempJune 10, 2022

Consultations Consultations Archive

NICE Consultations on Diabetes & UTIs

NICE is working on Consultation processes and updates regarding Diabetes in adults and urinary tract infections. Please find the information here on the Consultation regarding Diabetes in adults - Type 1 and Type 2. Please find the information here on the Consultation regarding urinary tract infections. The closing date for comments on both Consultations is: Friday 10 June 2022.

Ben KempJune 1, 2022