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Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party – Update 4 March

By March 4, 2022No Comments

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 has been granted an amendment to the initial implementation dates. These dates are staggered based on the risk classification of the products primarily, with some requirements still needing to be met by May 2023.

There are also a number of consultations ongoing in Europe and the UK for changes to the regulatory landscape. More information has been provided in these within the weekly Regulatory Affairs working party alerts.

An update was provided on the upcoming Plastics Tax and what it means for those in the IVD supply chain. HMRC are hosting webinars on the topic which BIVDA encourages members to watch, these are available at this page (type in your details and click register and you will see the video) .

A new programme has been launched by CPI in partnership with Innovate UK to aid organisations in regulation for IVDs. The programme allows manufacturers to claim a grant to support regulatory development and aims to provide overarching regulatory support in the form of training. BIVDA’s Regulatory Affairs Manager, Ashleigh Batchen, will be on the Expert Advisory Group assisting the programme, and BIVDA are keen to provide training to suit member needs.

There continue to be a range of movement in the IVD sphere for regulation for all stakeholders involved. MHRA continue to develop the update to the UK Medical Device Regulations, with their focus groups starting WC 7 March. BIVDA will be representing the membership in these groups and providing input to the MHRA guidance and additional documents intended to provide information in relation to the new regulations.

The next Working Party is scheduled for 23 June, with the working party seminar on 12-13 October.

Minutes and presentations will be produced shortly.