Eu regulation updates

Eu regulation updates. . SI – CCP Recovery and Resolution Apr 8, 2022 · The EU regulation 2017/745 on medical devices, or EU MDR, was a major update to medical device regulations introduced in 2017. 25 January 2024 EU Deforestation Regulation. 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. The GDPR adopts a decentralized enforcement model. 1 Guidance on standardisation for medical devices. Mar 13, 2024 · ECHA is making every effort to progress opinion making, following the updates made to the proposal by the five national authorities. Jun 24, 2020 · 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. Aug 22, 2023 · On 4 July 2023, the EU Commission proposed a new Regulation for procedural rules to standardize and streamline cooperation between EU Member State Data Protection Authorities (DPAs) when enforcing the EU General Data Protection Regulation (GDPR) in cross-border cases (GDPR Procedural Regulation). The changes will start to apply in early 2022 and companies need to start preparing. 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. Feb 7, 2023 · On 6 January 2023, the European Commission adopted a proposal to amend the transitional periods provided in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – the “proposal”. The draft act is open for public comment until May 8, 2024. Jan 2, 2024 · Origin. Jun 8, 2023 · In April 2021, the European Commission proposed the first EU regulatory framework for AI. Jan 28, 2022 · EU Clinical Trial Regulation 536/2014 (EU-CTR) aims to overcome EU-CTD’s shortcomings. 4 See Article 3k (3ac) of Regulation 833. Accelerating Clinical Trials in the EU (ACT EU) Building on the application of CTR and CTIS, in January 2022 the EC, the Heads of Medicines Agencies and EMA also launched the Accelerating Clinical Trials in the EU (ACT EU) initiative that seeks to 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. These are… Latest updates News announcement Jun 29, 2021 · The European Commission has revised certain information requirements for registering chemicals under REACH. ECHA will publish more advice in late 2021. 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. Jun 26, 2023 · The European Commission plans to publish the regulation in the fourth quarter of 2023 officially. Green Deal: New law to fight global deforestation and forest degradation driven by EU production and consumption enters into force - European Commission Mar 4, 2024 · In 2018, packaging generated a turnover of EUR 355 billion in the EU. , senior regulatory specialist, UL’s Supply Chain team . EU Member States notifications to the European Commission under the GDPR Jun 13, 2024 · The European Commission is reviewing the rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for human medicines. On Oct. The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU… Aug 25, 2022 · ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force. Mar 8, 2024 · Following their formal adoption by the Council of the EU on 20 February 2024, the amendments to the Markets in Financial Instruments Regulation (MiFIR) and the Markets in Financial Instruments Directive (MiFID II) were published in the Official Journal of the EU on 8 March 2024, marking the end of the procedural journey, which first began in November 2021. More information for companies and individuals. Feb 1, 2022 · This builds on one of the roles of the European Supervisory Authorities (ESAs) under the proposed EU Regulation on digital operational resilience for the financial sector (DORA) of building an effective EU-level co-ordinated response in the event of a major cross-border information and communication technologies (ICT) related incident or 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. It became mandatory on January 1, 2023; the European Commission launched two consultations, one public and one targetted, on the implementation of the SFDR on September 14, 2023 Apr 12, 2022 · The European Commission has revised certain information requirements for registering chemicals under REACH. Other documents issued by EU members. Summaries of EU legislation. 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 Jan 25, 2022 · The European Commission (EC) oversees the implementation of the Clinical Trials Regulation. 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. Aug 15, 2024 · Degraded ecosystems to be restored across Europe as Nature Restoration Law enters into force. At PEFC, we are committed to halting deforestation and strongly support the objectives of the EU Regulation on Deforestation-free Products (EUDR). It helps direct investments to the economic activities most needed for the transition, in line with the European Green Deal objectives. EMA Management Board confirmed to the European Commission on 21 April 2021 that the EU Portal and Database were fully functional. The EU General Data Protection Regulation went into effect on May 25, 2018, replacing the Data Protection Directive 95/46/EC. If adopted, the new regulations would go into effect after January 1, 2026. One REACH-IT account can contain registrations from only one non-EU manufacturer. The update adopts revisions 6 and 7 of GHS and implements changes to many of the 16 sections of the SDS. May 26, 2021 · Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. Dec 14, 2023 · a legislative act to amend the Capital Requirements Regulation (Regulation No (EU) 2013/575) Co-legislators confirmed that the new CRR rules will start applying on 1 January 2025. Consolidated version of the REACH Regulation. Read about a new EU law that enables ecodesign requirements and information to be set for almost all categories of physical goods that come onto the EU market. Search for directives, regulations, decisions, international agreements and other act. The regulation sets binding targets to restore degraded ecosystems, particularly those with the most potential to capture and store carbon and to prevent and reduce the impact of natural disasters. Jul 19, 2024 · 19 July 2024. 5. Directorate-General for Communication. May 2, 2022 · Thus, these substances can no longer be found in cosmetics sold in the EU: beauty brands must have recalled and reformulated their products. Regulation (EC) No 889/2008 consolidated version of 1 Jan. ECHA will publish further advice later this year. KEY POINTS POPs are dangerous chemical substances that may cross international boundaries, are often found far from their emission sources, persist in the environment, bioaccumulate * and consequently pose a threat to Commission Implementing Decision (EU) 2022/1497 of 8 September 2022 determining whether a product containing ‘Capsicum oleoresin expeller pressed’ is a biocidal product, pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance). It also includes provisions on so-called "golden” passports and visas. 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 May 24, 2024 · NPA 2024-04 - Regular update of Commission Regulation (EU) No 748/2012 and the associated acceptable means of compliance and guidance material (RMT. 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. Most recent legislative documents. Apr 24, 2024 · The European Parliament has adopted a package of laws strengthening the EU’s toolkit to fight money-laundering and terrorist financing. 1. Compliance with EU regulation 2018/848. 7 kg of packaging waste in 2021, a figure that is expected to increase to 209 kg in 2030 without additional measures. In October, a landmark deal has been made, easing online business, promoting digital trade, and enabling cross-border data flow. A selection of the latest legislative documents available on EUR-Lex. On February 1, 2022, the European Commission published the Regulation (EU) 2022/135 that foresees new restrictions for the fragrance ingredient M-N-MA. Update on consolidated version of Regulation (EU) 2018/848 After ten years of activities, the New EU Organic Regulation (EU) 2018/848 has entered into application. Jan 25, 2024 · The changes for EU apps reflect the European Commission’s designation of iOS, Safari, and the App Store as “core platform services” under the Digital Markets Act. 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 2, 2022 · The General Data Protection Regulation (GDPR) was a much-needed reform to how the European Union (EU) regulates data privacy. The Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. The draft sets some deadlines for applying the new restrictions. europa. Update of MDCG 2020-16 Rev. 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 Jun 14, 2024 · The EU has introduced several new regulations related to mycotoxins over the past year. In March, Apple will share new resources to help EU users understand the changes they can expect. Long-chain perfluorinated carboxylic acids (C9-21 PFCAs) are being considered for inclusion in the Stockholm Convention and consequent global elimination. May 22, 2023 · The Council has today adopted the new regulation on machinery. It seeks to minimise, or eliminate where possible, releases of such substances and regulate waste containing or contaminated by them. The regulation particularly takes into account the precautionary principle. Author. European Parliament. ec. Improving EU law-making is a shared objective and the responsibility of all EU institutions and Member States. Third edition. 5) Microsoft Word – Human Code. Photo by Maridav, Shutterstock. Companies Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. eu) European Commission EC Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation On July 19, 2023, European Commission has issued a guidance on transition the Clinical Trial Directive (CTD) to Clinical Trials Regulation (CTR). Apr 26, 2023 · The proposal adopted by the Commission revises and replaces the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively). Jan 27, 2022 · MAIN DOCUMENT Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5. Reduce packaging and restrict certain types. Sep 19, 2023 · Background. The European Union is implementing a new customs pre-arrival security and safety programme, underpinned by a large-scale advance cargo information system – Import Control System 2 (ICS2). by Percefoni Doufou-Shafiq, Ph. 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 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. Each European generated 188. Our first regulatory update described the three registration routes in Israel: Declaration Route, Fast-Track Route, and Normal Route. 0031 Subtask 3) | EASA (europa. The new rules extend producer responsibility and require due diligence of supply chains to assess social and environmental risks, with a key focus on the supply of cobalt, natural graphite, lithium and nickel. The EU therefore has legislation in place that requires companies to classify, label and package their chemicals before placing them on the market. It ensures an efficient use of resources and strengthens the quality of HTA across the Union. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure. The Agency will deliver the final opinions to the European Commission in the shortest possible timeframe while ensuring their transparency, independence and high quality. Enabling citizens to have a unique and secure European digital wallet while remaining in full control of their personal data is a key step forward for the EU, which will set a global benchmark in the digital field and enhance security when engaging with online services. The provision included in the CRD will need to be transposed by Member States before they start applying. Designed to increase data privacy for EU citizens, the regulation levies steep fines on organizations that don’t follow the law. Update of MDCG 2021-5 Rev. Evaluating and improving existing laws Dec 7, 2016 · The CLP Regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals. As expected, many delegated and implementing regulations related to the new EU Organic Regulation (EU) 2018/848 have been published the last days of 2021. pdf Jan 9, 2024 · The revised EU fisheries control regulation updates most of the rules for fishing vessels to modern technology and promotes sustainability. Apr 12, 2024 · In an effort to align EU rules with Codex Alimentarius standards, the European Commission (EC) has proposed amendments to its regulations for Listeria monocytogenes in ready-to-eat (RTE) foods. Aug 2, 2018 · 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. It has been amended several times, most recently by Regulation (EU) 2022/2400, which updates Annexes IV and V to the regulation. 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 key changes involve enhanced monitoring of fishing activities, better traceability of catches, and harmonised sanctions for rule violations. In this way, the industry has time to adapt, avoiding excessive financial and environmental costs. 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. Mar 26, 2024 · The adoption of the European digital identity regulation is a milestone in our society’s digital transformation. Jul 19, 2023 · Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation News announcement 19 July 2023 Directorate-General for Health and Food Safety 1 min read Feb 16, 2024 · Read how EU rules will make online platforms safer, fairer and more transparent, by countering illegal content, protect minors and more transparency on advertising New rules to protect your rights and activity online in the EU - European Commission In response to the European Climate Law and the need for stronger climate action, the European Commission reviewed the 2014 F-gas Regulation and, on 7 April 2022, proposed a new regulation to the European Parliament and the Council of the European Union. The proposed legislation updates the 2006 machinery directive and transforms it into a regulation. The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. As a regulation, EU-CTR is binding on all EU member states in its entirety – a key difference from EU-CTD. The Regulation incorporates the classification criteria and labelling rules agreed at UN level - the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). 28 SEPTEMBER 2023 hta_regulation-implementation_factsheet_en. Understanding CLP; Understanding Seveso; Legislation; Classification of substances and mixtures; Labelling and packaging ; Harmonised classification and 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. The non-EU manufacturer can appoint one Only Representative. It was a massive undertaking and one that is still being fine-tuned today. Jan 21, 2022 · The EU SDS regulation Annex II to Regulation (EC) 2015/830 was replaced by the updated Regulation EU 2020/878. 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 Nov 16, 2020 · Major changes to the European SDS regulation are on the horizon. The regulation entered into force on 24 May 2016 and applies since 25 May 2018. This agreement still needs to be formally approved by both institutions. On 29 June 2023, the Regulation on deforestation-free products entered into force. In March 2022 the European Commission published its proposal for a Revision of the F-Gas Regulation (2022/0099 COD) to replace the current regulation from 2014. 29, 2021, the EU published amendment (EU) 2021/1902 to Cosmetics Regulation 1223/2009, updating Annexes II (substances prohibited for use in cosmetics), III (substances allowed to be used with restrictions) and V (preservatives authorized for use in cosmetics). The key objective of the revision is to have a more ambitious phase-down of HFCs, meaning a much stronger shift to (very) low-GWP refrigerants in the coming years which will significantly impact the RACHP sector. eu) 6) Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products 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. Palm oil and soya account for more than two-thirds of this. doc (europa. The limits concern both the formulation content and Jan 13, 2023 · On 30 December 2022, Commission Delegated Regulation (EU) 2022/2553 was published in the Official Journal . Jan 25, 2024 · The latest EUDR updates at the European Commission level. 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. EU consumption represents around 10% of this global deforestation. Deliverables, Implementation and Compliance Nov 19, 2021 · Trading IMPORT There will be 2 options to export an organic product to the EU: Trade agreement guaranteeing the equivalence of the non-EU country's organic specification with the EU organic regulation. 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) Jun 18, 2024 · Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use Feb 27, 2024 · The Medical Device Regulation, EU is an essential update to the framework that governs the approval, oversight, and monitoring of medical tools in the European Union. Information about the incorporation of the General Data Protection Regulation (GDPR) into the EEA Agreement. See links here. The new text harmonises the essential health and safety requirements for machinery in the EU, promotes the free movement of machinery and ensures a high level of safety for workers and citizens. 1–175). Jun 14, 2024 · The EU has introduced several new regulations related to mycotoxins over the past year. 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. National implementing measures. 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. Jun 29, 2023 · Today, the pioneering EU Regulation on deforestation-free supply chains, a key building block in the fight against climate change and biodiversity loss, enters into force. Apr 4, 2024 · On 4 March 2024, the Parliament and the Council reached a provisional agreement on the new regulation. Oct 12, 2020 · Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance) Apr 19, 2023 · The UN Food and Agriculture Organization (FAO) estimates that 420 million hectares of forest — an area larger than the EU — were converted from forests to agricultural use between 1990 and 2020. 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. See full list on health. D. The main driver of deforestation is the expansion of agricultural land that is linked to the production of commodities like cattle, wood, cocoa, soy, palm oil, coffee, rubber, and some of their derived products, such as leather, chocolate, tyres, or furniture. The wind-down period applies to goods falling under CN codes 8504 10, 8504 21, 8504 22, 8504 23, 8504 31 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. 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. As reported by Emergo by UL, the Ministry of Health of Israel is implementing reforms to the registration process for medical devices and IVDs. The EU taxonomy is a cornerstone of the EU’s sustainable finance framework and an important market transparency tool. Find out more by reading the article, and for more information please contact an expert. 2017, pp. Aug 2, 2023 · A new batteries regulation will impact the design, production and waste management of all types of batteries manufactured or sold in the European Union. In this case the rules will therefore be exactly the same for a producer inside or outside the EU. This Delegated Regulation amends the RTS set out in Delegated Regulation (EU) 2019/815 as regards the 2022 update of the taxonomy for the single electronic reporting format. This concerns the Commission Regulation (EC) No 1234/2008 together with the variations guidelines within the existing legal framework of Regulation (EC) No 726/2004 and Directive 2001/83/EC. On 20 May 2021, the European Parliament and the Council adopted Regulation (EU) 2021/821. What is new in the updated Implementing Regulation? Marine equipment listed as a “new item inserted by Implementing Regulation (EU) 2022/1157”, which complies with the requirements or testing standards for type approval in force before 15 August 2022, may continue to be placed on the market and on-board EU ships until 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. Companies should start to prepare as the changes will begin to apply in October 2022. Overview of legislation by subject area. Dec 14, 2023 · Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Who it affects. 3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. 2021 (HTML and PDF versions in all the EU languages can be found here) Regulation (EC) No 1235/2008 (applied until 31 December 2021) Regulation (EC) No 1235/2008 of 8 December 2008 This regulation aligns with the EU’s 2019 Communication on Stepping up EU Action to Protect and Restore the World’s Forests, the European Green Deal, the EU Biodiversity Strategy for 2030, and the new EU Forest Strategy for 2030. 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 Dec 9, 2022 · The agreed rules will cover the entire battery life cycle, from design to end-of-life and apply to all types of batteries sold in the EU: portable batteries, SLI batteries (supplying power for starting, lighting or ignition of vehicles), light means of transport (LMT) batteries (providing power for the traction to wheeled vehicles such as electric scooters and bikes), electric vehicle (EV Dec 7, 2023 · 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. Mar 17, 2022 · EU Clinical Trial Regulation 536/2014 (EU CTR) replaces the EU Clinical Trial Directive (Directive 2001/20/EC). The different risk levels will mean more or less regulation. The revision aims to achieve the following main objectives: European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. Regulation (EU) 2021/181 on use of non-organic young poultry and protein feed and amending Annexes V and VIII. eu 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. Aug 29, 2024 · Israel Registration Update: Modifications and Renewals. SDS complying with the 2015 regulation are no longer acceptable. It seeks to increase transparency and restore the EU’s clinical research competitiveness by reducing administrative requisites and streamlining Every year trillions of Euros worth of goods are imported into EU, with the EU-27 now accounting for around 15 % of the world’s trade in goods. It says that AI systems that can be used in different applications are analysed and classified according to the risk they pose to users. Investors and other financial market participants (FMPs) Important dates to know. Access the authentic <i>Official Journal of the European Union</i>, EU law, EU case-law, consolidated texts, summaries of legislation, and much more. 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. It was activated in May 2021 and replaces previous directives with a more stringent and transparent system that enhances patient and user protection. Dec 6, 2023 · The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. The AI Act (Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence) provides AI developers and deployers with clear requirements and obligations regarding specific uses of AI. Applying EU law. SDS complying with the 2015 regulation will remain acceptable until December 31st, 2021. Sep 14, 2023 · Relevant for manufacturers CMC, yard and owners of EU flagged vessels. The new Export Control Regulation upgrades and strengthens the EU's export control toolbox to respond effectively to evolving security risks and emerging technologies, and allows the EU to effectively protect its interests and values. Jul 22, 2024 · AI Regulation: The EU’s first comprehensive AI Act aims to categorize AI applications by risk and establish specific regimes for large foundation models and generative AI. The MDR replaces the previous EU Medical Device Directive (MDD), and is designed to modernize the EU regulatory system to better address the current needs of the market and new technologies. Publication of MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The current versions of the Financial Regulation applies from 2 August 2018. At the same time, the regulation seeks to reduce administrative and financial burdens for business, in particular small and medium-sized Oct 5, 2023 · A factsheet summarising the Health Technology Assessment Regulation, its governance and implementation is now available in 23 EU languages. Database of infringement decisions. qfb zznp dooauit amxpv ytxrc kbquk dgyu bkwp lrncpr wjwae