Ben Kemp – Page 214 – BIVDA Newsletter

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Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety

The Post-market Surveillance (PMS) Statutory instrument (SI) laid in Parliament yesterday evening is the first major update to the framework of medical device regulations in Great Britain, led by the Medicines and Healthcare products Regulatory Agency (MHRA). You can find the press release here.

Ben KempOctober 25, 2024

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For information: European Ombudsman report on REACH Authorisation delays

Regarding EU REACH Authorisations for substances of very high concern. Of note are the two recommendations below, which could directly impact applicants requesting authorisation. Applying the rule that it is up to applicants to demonstrate that they have satisfied the legal conditions for obtaining the Authorisation by providing sufficient information, Ensuring that applications containing insufficient information are promptly dismissed, so…

Ben KempOctober 25, 2024

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The UK Government have released their position regarding the EU RoHS Exemption pack extension regarding the use of Cadmium for downshifting quantum dots directly deposited on LED semiconductors

The UK Government have released their position regarding the EU RoHS Exemption pack extension regarding the use of Cadmium for downshifting quantum dots directly deposited on LED semiconductors. This will apply to devices in Northern Ireland, but is not automatically extended to GB.

Ben KempOctober 25, 2024

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The UK government’s response to the EU REACH restriction of microplastics

The UK government's response to the EU REACH restriction of microplastics. The legislation will apply in Northern Ireland, but not in GB.

Ben KempOctober 25, 2024

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ECHA EUCLEF Chemicals Regulatory Support tool

ECHA and the national helpdesks work together to provide support to companies on the REACH, CLP and Biocidal Products regulations. National helpdesks are the first contact points for REACH and CLP questions. Find out more here.

Ben KempOctober 25, 2024

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Update: Biocide products in PT 1 – mycobacteria claims

Update: Biocide products in PT 1 – mycobacteria claims MHRA have confirmed that claims against mycobacteria are considered in scope of medicines regulations Article 2 of the Biocidal Product Regulation (BPR), sets out the scope of biocides regulations, including where products are considered out of scope because they are covered by other relevant regulations. For example, it is generally the…

Ben KempOctober 25, 2024

Environmental Newsletter Environmental Newsletter Archive UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

DEFRA Update (WC 21 Oct)

There are two EMs regarding changes to EU legislation, one for RoHS and one for Reach, that will apply in NI, but need to follow up on whether there is an intention to also apply in GB. RoHS is an exemption extension, if not adopted, it would mean that certain CE marked products containing LEDs could not be placed on…

Ben KempOctober 25, 2024

Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 21 Oct)

UK Science and Innovation Network impact stories Page summary: These impact stories highlight the work of the UK Science and Innovation Network (SIN) around the world. Change made: Impact story added on Technology partnerships between the UK and Central and Eastern Europe. Time updated: 11:24am, 14 October 2024 Tech Secretary welcomes foreign investment in UK data centres which will spur…

Ben KempOctober 25, 2024

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Climate Change Agreements: consultation on a new scheme

Climate Change Agreements: consultation on a new scheme Page summary: We’re seeking views on proposals for a new 6-year Climate Change Agreements scheme. Change made: The government response to this consultation has been published. Time updated: 9:30am, 16 October 2024

Ben KempOctober 25, 2024

Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Update (WC 21 Oct)

Non-financial reporting review: simpler corporate reporting Page summary: Seeking views on raising the employee threshold for medium-sized companies to 500 employees and exempting medium-sized companies from producing a Strategic Report. Change made: Page updated with outcome of consultation. Time updated: 9:00am, 14 October 2024 Value of non-financial reporting to investors Page summary: Research examining the benefits and value of non-financial…

Ben KempOctober 25, 2024