Regulatory Affairs Working Party

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,…

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…

The date of application for the IVDR is the 26 May 2022 – just one month away! There has been a huge amount of work to get us to this point, and I hope all our members are working towards IVDR compliance as quickly as possible. Where your products are benefitting from the amended transition periods published in January 2022,…

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 key changes. They are split by…

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…

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…

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…

This morning, the IVDR postponement was published in the Official Journal of the EU. This means that this is now legally binding, and the postponement will take effect. This pushes back the full implementation of the EU IVDR based on the risk class of the IVD, primarily due to the ongoing Covid-19 pandemic response which resulted in those involved in…

BIVDA held our Regulatory Affairs working party on Friday 17th December. 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. Numerous guidance pages have been drafted by MedTech Europe to ease compliance to the IVDR. As…