Eu regulation updates. 3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. Dec 22, 2023 · The latest on the EU’s PPWR . 4 See Article 3k (3ac) of Regulation 833. The text responds to a number of new challenges, mainly stemming from digital toys and online shopping, and converts the existing directive into a directly applicable regulation. It is an ever-increasing source of waste, the EU total having increased from 66 million tonnes in 2009 to 84 million tonnes in 2021. Since its first draft developed by the European Commission in September 2020 - which we covered in a previous article - numerous important changes have been made to the Act’s official text, published on 24 June 2022. Stay tuned for more updates on EU sustainability regulations over the coming months. Each European generated 188. The Regulation establishes a set of rules for integrated planning, monitoring and reporting under the five dimensions of the Energy Union: Update of MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 and Appendix: Clinical investigation summary safety report form. SDS complying with the 2015 regulation are no longer acceptable. Dec 6, 2023 · The EU and Japan initiated talks in October 2022 to include cross-border data flow rules in the EU-Japan Economic Partnership Agreement (EPA), aligning with the EU's commitment to modern digital trade regulations. Overview of legislation by subject area. Learn about EU law and how it is applied. Apr 24, 2024 · The regulation, which aims to tackle constantly growing waste, harmonise internal market rules and boost the circular economy, was approved with 476 votes in favour, 129 against and 24 abstentions. Orphan: EU/3/24/2952 - orphan designation for treatment of congenital alpha-1 antitrypsin deficiency: New: 13/09/2024 : Orphan: EU/3/24/2958 - orphan designation for treatment of Creutzfeldt-Jakob disease: New: 13/09/2024 : Orphan: EU/3/24/2945 - orphan designation for treatment of primary large B-cell lymphoma of immune-privileged sites: New Jun 14, 2024 · The EU has introduced several new regulations related to mycotoxins over the past year. ECHA will publish further advice later this year. 0031 Subtask 3) NPA 2024-04 - Regular update of Commission Regulation (EU) No 748/2012 and the associated acceptable means of compliance and guidance material (RMT. EU Member States notifications to the European Commission under the GDPR Sep 19, 2023 · Background. The Commission is currently revising the REACH Regulation, in line with the Commission’s Better Regulation provisions. The REACH Regulation (EC 1907/2006) entered into force in 2007 and has since evolved to reflect the advancement of knowledge regarding various chemicals and their properties. 0031 Subtask 3) | EASA (europa. Evaluating and improving existing laws Mar 13, 2024 · The Commission added the substance group in the EU's POPs Regulation in May 2023 and the regulation entered into force on 28 August 2023. eu) Jan 23, 2024 · In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety. 46 KB - HTML) Mar 11, 2024 · 3 See Council Regulation (EU) 2024/745 of 23 February 2024 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine. All are available in all 24 EU official languages via machine translation, when clicking on the full list of corresponding content. EMA Management Board confirmed to the European Commission on 21 April 2021 that the EU Portal and Database were fully functional. Latest EU cosmetic regulations update . Jun 8, 2023 · The use of artificial intelligence in the EU will be regulated by the AI Act, the world’s first comprehensive AI law. Summaries of EU legislation. The EU Packaging and Packaging Waste Regulation (PPWR), which aims at reducing packaging pollution and building a circular economy for packaging, has an overall objective to ensure all packs are designed for recycling by January 1st, 2030, and recyclable five years later. SDS complying with the 2015 regulation will remain acceptable until December 31st, 2021. These are… Latest updates News announcement Aug 9, 2024 · NPA 2024-04 - Regular update of Commission Regulation (EU) No 748/2012 and the associated acceptable means of compliance and guidance material (RMT. As of 29 June 2023 The Financial Regulation (FR) is the main point of reference for the principles and procedures governing the establishment, implementation and control of the EU budget. Ban on harmful chemicals Nov 17, 2023 · These cumulative efforts will contribute to a more sustainable and efficient reporting landscape. The EU therefore has legislation in place that requires companies to classify, label and package their chemicals before placing them on the market. Law - European Commission Consolidated version of the REACH Regulation. It was a massive undertaking and one that is still being fine-tuned today. The non-EU manufacturer can appoint one Only Representative. The Regulation incorporates the classification criteria and labelling rules agreed at UN level - the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). Mar 17, 2022 · EU Clinical Trial Regulation 536/2014 (EU CTR) replaces the EU Clinical Trial Directive (Directive 2001/20/EC). Nov 2, 2022 · The General Data Protection Regulation (GDPR) was a much-needed reform to how the European Union (EU) regulates data privacy. The regulation - as did the 2006 directive - defines the mandatory essential health and safety requirements that machinery products must fulfil to be placed on the European market, as well as the procedures for assessing their conformity Find information on EU court judgments, public consultations, data protection, fraud, and cross-border cooperation. Under the Regulation, any operator or trader who places these commodities on the EU market, or exports from it, must be able to prove that the products do not originate from recently deforested land or have contributed to forest degradation. Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746: August 2021: MDCG 2021-18: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) July 2021: MDCG 2021-17 Dec 6, 2023 · The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. 1 Commission Delegated Directive (EU) 2017/1975 of August 2017, to be read in conjunction with the Corrigendum; 3 Commission Delegated Directives (EU) 2017/1009 to (EU) 2017/1011 of March 2017; 2 Commission Delegated Directives (EU) 2016/1028 to (EU) 2016/1029 of 19 April 2016; Commission Delegated Directive (EU) 2016/585 of 12 February 2016 Jan 21, 2022 · The EU SDS regulation Annex II to Regulation (EC) 2015/830 was replaced by the updated Regulation EU 2020/878. 1. English (260. There is a three-year transition period: Previously, sponsors had to submit clinical trial applications separately to national authorities and ethics committees (ECs) in each country to gain regulatory approval to run a clinical trial. Nov 16, 2020 · Major changes to the European SDS regulation are on the horizon. Jan 23, 2020 · 11 Key Changes to the EU Medical Device Regulation (update summary) Unique Device Identification (UDI) System (Article 27, Annex VI) A UDI device identifier (UDI-DI) and a UDI production identifier (UDI-PI) will be required on all products to be placed on the EU market, with the exception of custom-made devices and investigational devices. It is also possible to find what measures countries take to incorporate EU legislation into national law and track infringement procedures taken by the European Commission against EU countries. The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU… The most recent consolidated version includes the adaptations to technical progress up to the 16th ATP, but does not yet incorporate Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 (15th ATP) as this update applies from 1 March 2022 nor Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 (17th ATP) as this update Jun 29, 2023 · The EU's new Deforestation Regulation requires companies trading in cattle, cocoa, coffee, oil palm, rubber, soya and wood, as well as products derived from these commodities, to conduct extensive diligence on the value chain to ensure the goods do not result from recent (post 31 December 2020) deforestation, forest degradation or breaches of local environmental and social laws. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 Jul 19, 2024 · On 30 March 2022, the European Commission proposed an Ecodesign for Sustainable Products Regulation (ESPR) as part of the Commission's Circular Economy Action Plan under the European Green Deal. Update of MDCG 2021-5 Rev. EU Battery Regulation update 2023/1542 Table Of Contents As the global demand for batteries escalates, driven by advancements in technology and the transition to renewable energy, the European Union has taken decisive steps to ensure that the lifecycle of batteries aligns with stringent environmental, safety, and performance standards. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical device. Reduce packaging and restrict certain types. Mar 28, 2023 · the EU “single rulebook” - regulation - with provisions on conducting due diligence on customers, transparency of beneficial owners and the use of anonymous instruments, such as crypto-assets, and new entities, such as crowdfunding platforms. Find out how it will protect you. In line with the most recent EU cosmetic regulations update, which will take effect on October 1, certain popular beauty ingredients are to be considered as CMRs and their use in beauty products should be discontinued or restricted by manufacturers. These updates aim to simplify existing regulations, update thresholds for certain mycotoxins and commodities, bring changes to the sampling process, and introduce a new requirement for mycotoxin testing. Jun 16, 2021 · Our food contact expert shares their take on the proposed 16th amendment updates to EU Regulation 10/2011, including the impact of certain removals and changes to requirements for specific materials. Most cover the main types of legislation passed by the EU: directives, regulations and decisions. Apr 10, 2024 · Welcome to the UK Regulation Round Up, a regular bulletin highlighting the latest developments in UK and EU financial services regulation. Mar 4, 2024 · In 2018, packaging generated a turnover of EUR 355 billion in the EU. Applying EU law. Sep 5, 2024 · Browse through a selection of Featured EU news, see a comprehensive overview of the Latest EU news or read about past and upcoming events from all EU’s institutions and bodies. Publication of MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746. pdf Aug 25, 2022 · ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force. The current versions of the Financial Regulation applies from 2 August 2018. Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and deferred the application of conditions for in-house devices. . 5 days ago · Adopted in 2018, the Regulation (EU) 2018/1999 established a new governance mechanism to help the EU and its Member States reach the 2030 climate and energy targets and meet the Paris Agreement goals. The CSRD is still set to come into effect in 2024 as part of the EU sustainability regulations, with few delayed rules taking effect at a later date. A selection of the latest legislative documents available on EUR-Lex. Mar 13, 2023 · On 22 September 2022, the UK government introduced the Brexit Freedoms Bill, under which all EU legislation will be amended, repealed, or replaced. Apr 12, 2022 · The European Commission has revised certain information requirements for registering chemicals under REACH. 1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in Jan 31, 2022 · Although the Regulation entered into force on 16 June 2014 the timing of its application depended on the development of a fully functional EU clinical trials portal and database. Long-chain perfluorinated carboxylic acids (C9-21 PFCAs) are being considered for inclusion in the Stockholm Convention and consequent global elimination. In October, a landmark deal has been made, easing online business, promoting digital trade, and enabling cross-border data flow. National implementing measures. In 2024, new packaging rules are set to come into force in the EU. Find out more by reading the article, and for more information please contact an expert. One REACH-IT account can contain registrations from only one non-EU manufacturer. Database of infringement decisions. Update of MDCG 2020-16 Rev. Access the authentic <i>Official Journal of the European Union</i>, EU law, EU case-law, consolidated texts, summaries of legislation, and much more. Key developments in March 2024: 28 March FCA Regulation The regulation entered into force on 24 May 2016 and applies since 25 May 2018. Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery replaces Directive 2006/42/EC on machinery. It also includes provisions on so-called "golden” passports and visas. In the European Union, the new regulation on cyber security will be mandatory for all new vehicle types from July 2022 and will become mandatory for all new vehicles produced from July 2024. Returning from a long holiday and need to catch up on EU medical device and IVD regulatory developments? Read our update on European regulatory news over the last few months. Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. Most recent legislative documents. 28 SEPTEMBER 2023 hta_regulation-implementation_factsheet_en. Oct 5, 2023 · A factsheet summarising the Health Technology Assessment Regulation, its governance and implementation is now available in 23 EU languages. Improving EU law-making is a shared objective and the responsibility of all EU institutions and Member States. Jul 8, 2024 · MDCG 2020-16 Rev. Summaries of EU legislation are short, easy-to-understand explanations of the main legal acts passed by the EU – intended for a general, non-specialist audience. Information about the incorporation of the General Data Protection Regulation (GDPR) into the EEA Agreement. Jun 29, 2021 · The European Commission has revised certain information requirements for registering chemicals under REACH. The changes will start to apply in early 2022 and companies need to start preparing. Designed to increase data privacy for EU citizens, the regulation levies steep fines on organizations that don’t follow the law. Together, the EU, the Republic of Korea and Japan accounted for some 32 million vehicles produced in 2018, representing just over one third of global May 24, 2022 · The Only Representative must declare their non-EU manufacturers they represent and provide their contact information in REACH-IT by October 14, 2022, starting from April 26, 2022. Search for directives, regulations, decisions, international agreements and other act. Companies should start to prepare as the changes will begin to apply in October 2022. More information for companies and individuals. Apr 24, 2024 · The European Parliament has adopted a package of laws strengthening the EU’s toolkit to fight money-laundering and terrorist financing. Sep 29, 2023 · Latest updates Updated document - Questions & Answers : Clinical Trials Regulation (EU) No 536/2014 News announcement 29 September 2023 Directorate-General for Health and Food Safety 1 min read In July 2022, the European Commission adopted the proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application Sep 9, 2024 · EU Update: Current State of Medical Device Regulations. Effective January 1st, 2021, the EU SDS regulation Annex II to Regulation (EC) 2015/830 will be replaced by the updated Regulation EU 2020/878. The update adopts revisions 6 and 7 of GHS and implements changes to many of the 16 sections of the SDS. Find out how updates to data protection rules will affect you individually, (23 May 2018) to Regulation (EU) 2016/679 on data protection. ECHA will publish more advice in late 2021. The Regulation on deforestation-free products repeals the EU Timber Regulation. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. The EU’s Carbon Border Adjustment Mechanism (CBAM) is the EU's tool to put a fair price on the carbon emitted during the production of carbon intensive goods that are entering the EU, and to encourage cleaner industrial production in non-EU countries. Companies Jun 14, 2024 · The EU has introduced several new regulations related to mycotoxins over the past year. The wind-down period applies to goods falling under CN codes 8504 10, 8504 21, 8504 22, 8504 23, 8504 31 Oct 21, 2022 · The European Commission adopted the annual Delegated Regulation that updates the EU dual-use export control list in Annex I to Regulation (EU) 2021/821 (dual-use Regulation) European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. The best way to improve EU law-making and deliver better results is for the European Parliament, the Council of the European Union and the European Commission to work more closely together in the coming years. 7 kg of packaging waste in 2021, a figure that is expected to increase to 209 kg in 2030 without additional measures. As it currently stands, EU regulations and tertiary legislation relating to food and nutrition are retained as UK law under the powers contained within the European Union (Withdrawal) Act 2018. 1 Guidance on standardisation for medical devices. The EU General Data Protection Regulation went into effect on May 25, 2018, replacing the Data Protection Directive 95/46/EC. But some cover other documents, such as international agreements. 3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024 Member States should pay particular attention to the implementation of horizontal Community legislation and measures regarding counterfeit products in the field of cosmetic products, for example Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property Mar 13, 2024 · On Wednesday, Parliament approved its position on revamped EU rules on toy safety with 603 votes in favour, 5 against and 15 abstentions. ddbt efdek ccvyj nqkypx voeccd euuu axbaudsh jtuldf oeyjv ornlc