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Derogations proposed for D4/D5/D6 European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Derogations proposed for D4/D5/D6

The restriction proposal for D4/D5/D6 is expected to be discussed within REACH Committees in June 2023. ECHA has proposed derogations for medical technologies, including for certain uses or increased allowable concentrations: Dental impression materials Medical devices for scar and wound management, and stoma care More information can be found on the Silicones Europe website. This information was kindly provided…

adminApril 28, 2023

HMRC weekly update (WC 17 Apr) UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

HMRC weekly update (WC 17 Apr)

Please note this is an extract of the original bulletin. Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: Appendix 1: entry summary declaration data elements for the S&S GB service has been updated to include a link to location…

adminApril 28, 2023

Request for information on labelling BIVDA Updates Environmental Newsletter BIVDA Updates Environmental Newsletter Archive BIVDA updates Regulatory Affairs Newsletter BIVDA Updates Regulatory Affairs Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive MedTech Europe Updates Regulatory Affairs Newsletter MedTech Europe Updates Regulatory Affairs Newsletter Archive

Request for information on labelling

There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…

adminApril 21, 2023

Joint industry statement on the PPWR Single Market Legal Basis Industry newsletters Environmental Newsletter Industry Newsletters Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Joint industry statement on the PPWR Single Market Legal Basis

The joint industry statement on the PPWR Single Market Legal Basis has now been made public. This urges co-legislators to preserve the internal market legal basis for the Packaging and Packaging Waste Regulation as the best way to achieve proposed environmental and economic objectives. The document is planned to be circulated amongst various key stakeholders, including the European Commission. …

adminApril 21, 2023

MHRA extends MORE portal deadline to 31 August UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

MHRA extends MORE portal deadline to 31 August

MHRA have extended the deadline for their new MORE portal to 31 August. It was initially intended to be mandatory for vigilance reporting to MHRA from April. MHRA have provided the following information: The MHRA has been listening to feedback and engaging with device manufacturers and stakeholders since the new MORE portal was launched in November 2022. We understand that…

adminApril 21, 2023

ECHA weekly update (WC 17 Apr) European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive Upcoming Events Environmental Newsletter Upcoming Events Environmental Newsletter Archive

ECHA weekly update (WC 17 Apr)

ECHA has published their latest weekly update (12 April). Due to changes in the structure of ECHA's updates, we can no longer link to updates themselves. To ensure BIVDA members continue to receive this information, we have opted to provide the full ECHA notification. Watch our webinar on ECHA's new public data availability system The recording and presentations from our…

adminApril 21, 2023

DEFRA weekly update (WC 10 Apr) UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

DEFRA weekly update (WC 10 Apr)

Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Use the lists to check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved…

adminApril 21, 2023

APHA weekly update (WC 10 Apr) UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

APHA weekly update (WC 10 Apr)

Please note this is an extract of the original bulletin. Balai Directive: approved premises Page summary: Institutes, centres and premises in Great Britain approved to move animals, semen and embryos covered by the Balai Directive. Change made: Updated approval date for Amazon World Zoo Park, New Forest Wildlife Park and Woburn Safari Park.Added Messingham Zoo Ltd to the list.…

adminApril 21, 2023

HSE publications WC 17 Apr UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

HSE publications WC 17 Apr

HSE have published their latest bulletins: Classification Labelling and Packaging (CLP) 11 April: Publication of GB mandatory classification and labelling (GB MCL) technical reports - The next batch of GB MCL technical reports is now available for download* ECHA public consultation: call for comments for (deadline 26 May): • 4-phenylbenzophenone (EC: 218-345-2; CAS: 2128-93-0). Chemical registered under REACH. Human…

adminApril 21, 2023

DHSC weekly update (WC 10 Apr) UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 10 Apr)

Please note this is an extract of the original bulletin. Hewitt review: call for evidence Page summary: We want your views on how the oversight and governance of integrated care systems can best enable them to succeed. Change made: Added link to the Hewitt Review, which forms the outcome of this call for evidence.

adminApril 21, 2023