MedTech Europe Updates Environmental Newsletter – Page 5

New Guidance (MDCG 2024-13) on the Qualification of Ethylene Oxide for Medical Device Sterilization Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

New Guidance (MDCG 2024-13) on the Qualification of Ethylene Oxide for Medical Device Sterilization

An update from MedTech Europe on the newly published MDCG guidance mdcg 2024-13 regarding (Ethylene Oxide (EtO) used to sterilise MD and IVDs. It clarifies the status of EtO as not being under the Biocides Regulation (where it would have been banned), but falling under the MDR/IVDR, but not in itself being a medical device. Dear Members, We are…

Ben KempNovember 1, 2024

For information: European Ombudsman report on REACH Authorisation delays Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

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

For information and review by 21 Oct: Follow-up on Potentially Impactful Substances Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

For information and review by 21 Oct: Follow-up on Potentially Impactful Substances

Update from MTE Chemicals WG. If any members are impacted they need to let use know. Dear members, I hope this email finds you well. We would like to follow up with you on a few substances on which members were recently consulted on and inform you of the outcomes: Octamethyltrisiloxane (EC 203-497-4, CAS 107-51-7): On…

Ben KempOctober 16, 2024

EU Commission Warns 17 Member States Over Failure to Implement CSRD Sustainability Reporting Rules Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

EU Commission Warns 17 Member States Over Failure to Implement CSRD Sustainability Reporting Rules

The European Commission announced that it has sent letters to 17 EU member states, opening infringement procedures with the states over their failure to communicate that they have fully transposed the new Corporate Sustainability Reporting Directive (CSRD) into their national laws. Find out more here.

Ben KempOctober 2, 2024

ESPR: COM publishes FAQ document Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

ESPR: COM publishes FAQ document

The EC have issued a FAQ regarding the EU ESPR (ECO Design and Sustainable Products Regulation) which includes MD/IVDs in scope. This replaces the traditional legislation that focused on consumer white goods, and the energy usage and water consumption figures etc. Beyond the fact that we could eventually see ECO Design requirements being placed on the sector for products, the…

Ben KempOctober 2, 2024

PPWR Stakeholder Consultation Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

PPWR Stakeholder Consultation

This is an issue with the current Labelling directive, where we are seeing potentially 27 different member approaches and non-harmonised labelling requirements, as a consequence this is causing issues with companies having to place different SKUs of the same product on the different member state markets because of national differences in labelling requirements. The harmonised approach is designed to help…

Ben KempOctober 2, 2024

For review by 19 Sept: Weekly ECHA Substance Evaluations Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

For review by 19 Sept: Weekly ECHA Substance Evaluations

MedTech Europe have set deadline for feedback at 19th September, therefore BIVDA members would need to inform us by the 18th September. Note also the comment from the previous week's update that one of the substances is flagged as having medical or healthcare applications already identified. Octamethyltrisiloxane (EC 203-497-4, CAS 107-51-7) à the proposal lists medical and healthcare applications among…

Ben KempSeptember 11, 2024

MedTech Europe Views on the European Commission Delegated Regulation amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards Dechlorane Plus Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

MedTech Europe Views on the European Commission Delegated Regulation amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards Dechlorane Plus

Dear Members, please see this MedTech Europe paper and message below, regarding the inclusion of Dechlorane plus in EU POP’s legislation, this will impact products placed on the EU and Northern Ireland markets. I will also submit this to HSE for their reference, since Dechlorane Plus is being added to the Stockholm convention, and the UK is also a signatory…

Ben KempSeptember 11, 2024

EU EcoDesign Requirements for Sustainable Products Regulation Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

EU EcoDesign Requirements for Sustainable Products Regulation

Dear members, MedTech Europe Circular Economy Working Group have drafted a guide to the new EU EcoDesign Requirements for Sustainable Products Regulation. IVDs are in scope both directly, and indirectly due to the inclusion of horizontal categories being included that will impact the sector e.g. Iron, Aluminium, other metals, glass, plastic, chemicals, detergents etc. Because this is an internal MedTech…

Ben KempSeptember 11, 2024

Start of Hungarian Presidency – final Presidency Programme & key dates to remember Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Start of Hungarian Presidency – final Presidency Programme & key dates to remember

Dear Members, please see below update on the the focus of the Hungarian Presidency of the EU, impacting chemicals and circular economy workstreams. Dear members, the Hungarian Presidency starts today – please see the final programme of the Presidency here. Its overriding theme is “Making Europe Great Again”. With respect to Sustainability, it confirms the priorities shared earlier in…

Ben KempSeptember 11, 2024