European Commission Updates Regulatory Affairs Newsletter – Page 13

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EU Parliament votes on CLP revision and proposal on Microplastic Pellet Losses

On 23 April, the European Parliament voted on two files relevant to MedTech Europe from a chemicals angle: the CLP Regulation core revision and the Commission proposal for a Regulation on Microplastic Pellet Losses. 1. CLP Core Revision This is a file MedTech Europe engaged in over the last few years via public consultations and interviews with Commission consultants, with…

adminMay 1, 2024

EU parliament approves the final provisional agreement on the Packaging and Packaging Waste Regulation (PPWR)

On 24 April, the plenary of the European Parliament approved the final provisional agreement on the Packaging and Packaging Waste Regulation (PPWR). The EP’s endorsement of the following elements of the agreement reached with the Council: Article 6.11 and 6.12 (renumbered) – recyclability/recycling of scale: A material neutral approach is enacted for the following medtech specific derogation from newly introduces…

adminMay 1, 2024

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

Publication of MDCG 2022-9 rev.1 Summary of safety and performance template

Directorate-General for Health and Food Safety has published the first revision of MDCG 2022 – 9: “MDCG 2022-9 rev.1 – Summary of safety and performance template”. Members are requested to provide any comments to Regulatory@bivda.org.uk by 30 April.

adminApril 17, 2024

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

European Commission publishes two implementing decisions on medical device harmonised standards

The European Commission have published two Implementing Decisions regarding medical device harmonised standards: "Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products."This Implementing Decision…

adminMarch 21, 2024

Proposed EU Sustainability Reporting Standards for Small Companies

The European Financial Reporting Advisory Group (EFRAG) announced the release of new exposure drafts containing proposed sustainability reporting standards for SMEs. This marks the next step in establishing a new sustainability reporting system in Europe under the EU’s Corporate Sustainability Reporting Directive (CSRD). The new standards are composed of general sections covering general requirements, general disclosures, and policies, actions and…

adminJanuary 31, 2024

Sustainability Reporting Standards for Specific Sectors and non-EU Companies delayed for 2 years

On 24 January, the European Parliament approved a proposal to delay key aspects of the Corporate Sustainable Reporting Directive (CSRD) by 2 years, including the adoption of standards for companies to provide sector-specific sustainability disclosures and for sustainability reporting from companies outside of the EU. The proposal was made by the EU Commission in October. It highlighted the postponement of…

adminJanuary 31, 2024

EU Adopts New Regulation to eliminate 500M Tonnes of Greenhouse Gas Emissions

On 29 January, the EU Council announced that they have adopted a new legislation aimed at phasing down the emissions of highly potent greenhouse gases including fluorinated gases (F-gases) and ozone depleting substances (ODSs). This will result in the elimination of 500 million tonnes of CO2-equivalent emissions by 2050. The new rules will enter into force 20 days after publication…

adminJanuary 31, 2024

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European Commission publishes a proposal amending the EU MDR and EU IVDR

A proposal for amending Regulations (EU) 2017/745 (EU MDR) and (EU) 2017/746 (EU IVDR) has been published by the European Commission (EC) on 23 January. The European Commission propose a gradual roll-out of the European database on medical devices (EUDAMED), obligations in case of supply interruption, and transitional provisions for certain in vitro diagnostic medical devices (IVDs). This proposal includes:…

adminJanuary 24, 2024

EU parliament approves a new law for sustainability claims

On 17 January, the EU Parliament approved the adoption of a new anti-greenwashing law banning a series of commercial practices, including the use of unproven generic product claims such as “environmentally friendly,” or “climate neutral,” or marketing a product as having a reduced environmental impact based on the use of emissions offsetting schemes. The new law contains rules on product…

adminJanuary 24, 2024

EU proposed position on intellectual property of genetic resources and traditional knowledge with genetic resources

A recommendation is put forth for Council Decision authorizing the initiation of negotiations on an international legal instrument regarding intellectual property, genetic resources, and traditional knowledge associated with genetic resources. The proposal provides an explanatory memorandum that outlines the context, legal elements, and Union competence for the recommendation.

adminJanuary 17, 2024