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Regulatory Affairs Working Party Archive

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HMRC urges businesses to switch to the new Customs Declaration Service for exchange of goods between GB and UK

HMRC has reached out to businesses this week alerting them of the need to utilise the new Customs Declaration Service in advance of 30 September 2022. The new streamlined customs IT platform must be used from this date onwards, and it will replace the previous Customs Handling Import and Export Freight (CHIEF), representing a significant upgrade by providing businesses with…
Natalie Creaney
June 24, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Upcoming changes to the Northern Ireland Protocol may affect IVD supply in Northern Ireland

The UK left the European Union on 31 January 2020. This meant that the UK would no longer follow EU legislation. However, it was agreed under the Northern Ireland Protocol that Northern Ireland would continue to follow the EU system, including EU legislation. As a result, this meant that there are key differences between Northern Ireland and Great Britain requirements,…
admin
May 20, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

MDCG has published guidance on significant changes under the IVDR

These updated transition periods mean that organisations do not need to conform to the full scope of the IVDR dependent on the risk classification of their product, but also ‘freezes’ the product as significant changes cannot be made to the product during this period. Where significant changes are made, the product must conform to the full scope of the IVDR…
admin
May 6, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA to support TOPRA in IVD global market training

Ashleigh and BIVDA members, Simon Richards (Abbott) and Robyn Meurant (ACT-IVD), will be chairing and sharing expertise on the TOPRA course for IVD Regulatory Affairs for Global Markets. This will be held 27-29 April at the TOPRA offices in London, and feature talks on regulation in the UK, Australia, USA, China, Canada, Japan, Brazil and Latin America, Saudi Arabia, and…
Ben Kemp
April 14, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs News – The first MHRA focus group meeting

The first MHRA focus group meeting Those of you who attended the Regulatory Affairs Working Party meeting on Thursday 3rd March, you will have heard that the introductory meeting for MHRA’s focus groups occurred on Monday 7th March. The aim of these focus groups is to help develop guidance in relation to the new UKCA regulations and provide insight into…
Ben Kemp
March 11, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party – Update 4 March

BIVDA held our Regulatory Affairs working party on Thursday 3 March. The meeting provided an update on the ongoing and future regulatory work being conducted within the IVD sector. This was opened by a presentation from Richard Saunders, our chair, on the European situation. MedTech Europe continue to provide guidance documents to support the implementation of the EU IVDR which…
Ben Kemp
March 4, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Common Registration errors on MHRA system

At a recent meeting between MHRA and Trade Associations, it was raised that MHRA are utilising the registrations system as a method of monitoring compliance of products. This includes rejecting applications for registration where there are errors or omissions rather than giving the applicant an opportunity to correct those mistakes. This results in the products needing to be removed from…
admin
February 25, 2022
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