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4 December 2023
in European Law

Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements

The MDGC (Medical Device Coordination Group) has published guidance in order to ensure timely compliance with MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Regulation). The study calls on manufacturers, and the bodies that help regulate them, to increase transparency in regards to the timeline for conformity assessments and increase their public availability. […]

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1 December 2023
in European Law

EU regulator implements decision on harmonised standards for construction products.

On 7 November 2023, the European Commission adopted Decision (EU) 2023/2461 implementing harmonised standards for construction products. This Decision entered into force on 9 November 2023. This Decision amends Decision (EU) 2019/451 by adding five new entries (8-12) that deal with residential solid fuel burning appliances. These are: Room heaters. Inset appliances including open fires. […]

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1 December 2023
in European Law

EU Commission adopts new decision on recycled plastic content in single use bottles

On 30 November 2023, the Commission adopted Decision 2023/2683 on the rules regarding recycled plastic content in single use bottles (Recycled Content in Bottles Decision = RCBD). The RCBD implements Directive 2019/904 (Reduction of Impact of Plastic Products Directive = RIPPD). It will enter into force on 4 December 2023. The RCBD lays down the […]

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20 November 2023
in European Law

EU Member States and European Commission adopt a Medical Device Software Hardware combinations Guidance

On 18 October 2023, the Medical Device Coordination Group (MDCG), a group composed of representatives of all Member States and chaired by a representative of the European Commission, adopted a Medical Device Software (MDSW) Hardware combinations Guidance. This Guidance is aimed at helping manufacturers of medical software understand how to make products in conformity with […]

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20 November 2023
in European Law

The European Commission assigns a Unique Device Identifier for contact lenses

On 10 July 2023, the European Commission adopted Regulation (EU) 2023/2197 that modifies Part C of Annex VI to Regulation (EU) 2017/7405 on medical devices by setting new requirements that will equally apply to both (i) standard contact lenses and (ii) made to order contact lenses. These requirements will obligatorily apply as from 9 November 2025, although […]

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20 October 2023
in European Law

The European Commission updates the EU’s Ecolabelling Criteria

On 14 September 2023, the European Commission adopted a Decision (2023/6024) which updates the EU’s Ecolabelling Criteria for absorbent hygiene products and menstrual cups. This Decision has been effective since 21 September 2023. It repeals Decision 2014/763 as it introduces new criteria for absorbent hygiene products and reusable menstrual cups, aligning with market trends and […]

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4 August 2023
in European Law

CE marking will continue to be recognised across the UK except for medical devices and construction goods

On 1 August 2023 the UK Department for Business and Trade announced that the UK government intends to continue to recognise the CE marking across the UK, indefinitely. This means that the UKCA (UK Conformity Assessed) marking on products will not be required from British importers and distributors of EU-made products or of products that bear […]

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27 October 2022
in European Law

Commission regulation regarding additives to tuna meant for human consumption

On 10 October 2022, the European Commission adopted Regulation (EU) 2022/1923, re-authorizing the use of ascorbic acid, sodium ascorbate, and calcium ascorbate—compounds of Vitamin C—as additives for tuna products. An investigation by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated these substances, concluding no safety concerns from their use. […]

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27 October 2022
in European Law

European Commission proposal for a Council Decision regarding the 33rd Energy Charter Conference

On 5 October 2022, the European Commission adopted a proposal for an EU Council Decision on behalf of the European Atomic Energy Community (Euratom) under the 33rd Energy Charter Convention. This upcoming Convention is to adopt the following proposed amendments and modifications to the Energy Charter Treaty (ECT): 1) amending the ECT to align with […]

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27 October 2022
in European Law

Commission regulation to establish containment of an invasive pest

On 11 October 2022, the European Commission adopted Implementing Regulation (EU) 2022/1927 regarding protective measures against the species Aleurocanthus spiniferus, also called a citrus spiny whitefly. This pest targets citrus and tea plants, and it originates from tropical Asia. It has been discovered in the Dubrovnik Neretva and Split Dalmatia counties of Croatia and the […]

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