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

DBT weekly update (WC 20 May)

Please note this is an extract of the original bulletin. Smarter regulation and the regulatory landscape Page summary: Call for evidence on what works and what could be improved across the landscape of UK regulators. Change made: Consultation outcome updated. Conformity assessment testing under mutual recognition or free trade agreements Page summary: When you can use a designated UK-based conformity…

adminMay 29, 2024

FDA updates Regulatory Affairs Newsletter FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 20 May)

FDA Webinar: Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances The U.S. Food and Drug Administration (FDA) is announcing a webinar to discuss draft guidances: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564,when finalized, will describe the FDA’s enforcement policy for certain laboratory…

adminMay 29, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

HSE publications WC 20 May

HSE have published their latest bulletins: Biocides 15 May: Upcoming GB active substance expiry dates Biocidal products must be phased off the GB market The active substance/product type combinations listed below are due to expire under the GB BPR on the following dates: 1-methyl]-1H-1,2,4-triazole (Propiconazole) (CAS 60207-90-1 EC 262-104-4) in product type 9 (deadline: 31 May 2025) Carbon dioxide (CAS…

adminMay 29, 2024

European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive

ECHA weekly update (WC 13 May)

ECHA has published their latest weekly update (17 May). Due to changes in the structure of ECHA's updates, we can no longer provide a link to the updates themselves. To ensure BIVDA members continue to receive this information, we have opted to provide the full ECHA notification. Join our IT tools user group for Drinking Water Directive We have…

adminMay 22, 2024

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

MHRA publishes draft policy statement on International recognition of medical devices

The MHRA have published a statement of policy intent for recognition of approvals of medical devices from international regulators by the UK. This statement of policy intent is intended to inform partners of the MHRA’s direction of travel. The legislation will come into being at the same time as the future core regulations – anticipated to be late in 2024…

adminMay 22, 2024

Membership News Membership News Archive Regulatory Affairs Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter

MHRA launches public consultation on common specifications for high-risk IVDs

The MHRA have launched a 4-week public consultation on common specification requirements for high risk IVDs. They are seeking views on the inclusion of these requirements for certain high-risk IVDs and on the removal of the Coronavirus Test Device Approval (CTDA) process from UK MDR 2002. The common specification policy intends to improve the safety profile of high-risk IVDs and…

adminMay 22, 2024

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

MHRA weekly update (WC 13 May)

Please note this is an extract of the original bulletin. MHRA announces dedicated new team to support the international community in tackling antimicrobial resistance Page summary: Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics…

adminMay 22, 2024

Other Updates Environmental Newsletter Other Updates Environmental Newsletter Archive

Ukraine introduces CLP regulation

On May 10, 2024, the Ukrainian government approved the Technical Regulation on the classification, labeling, and packaging of chemical products (“UA-CLP”). This regulation integrates the norms of the European CLP Regulation. This regulation will enter into force after 6 months from the date of publication. The text of the regulation, including Annex VIII “Correspondence Table between EU CLP and UA-CLP”…

adminMay 22, 2024

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive European Commission Updates Regulatory Affairs Newsletter European Commission Updates Regulatory Affairs Newsletter Archive

REACH Restriction of D4/5/6 published in EU Official Journal

The REACH Restriction of D4/5/6 was published in the EU Official Journal on 17 May 2024. It will enter into force 20 days from the date of publication. This marks the end of the legislative process for the regulation of this substance under the Restriction route. The following derogations requested by MedTech Europe have been granted: The new transitional period…

adminMay 22, 2024

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

Office for Life Sciences – publications (WC 13 May)

The Office for Life Sciences have published their latest updates. OLS Stakeholder Bulletin - 17 May Cabinet Office Borders Bulletin - 17 May These include updates on news, including regulatory updates, transitional guidance and events.

adminMay 22, 2024