This video gives a quick outline of the different legislative acts (Directives, Regulations and Decisions) used by the EU and highlights the main differences between them. For more information on the EU and its institutions please subscribe to our channel. In this series we explain complex aspects of the EU in a comprehensive and understandable way. If however, despite our diligence and help of Dr. Jan Oster, we have left something out or made a mistake, please be so kind to tell and forgive us. -------------------------------------------------- With Ciceroni we seek to be a guide to European culture and history. We make videos on little known subjects as well as more ubiquitous ones, ranging from current affairs like the European Union, to historic events like the Tulip Mania, and even mythological stories like those of the Greek Gods. In all these videos we strive to present the subjects in a objective manner and within their complex context. Become a Patron: https://www.patreon.com/Ciceroni Follow us on Twitter: https://twitter.com/Ciceroni_EU Like us on Facebook: https://www.facebook.com/CiceroniChan...
Views: 28400 Ciceroni
The European Parliament will vote on its controversial Copyright bill on Wednesday, September 12, 2018. The directive aims to ensure that producers of creative content are remunerated fairly online. Its supporters think the new regulation will protect the rights of the content producers, while its critics say it will destroy the public domain. Watch this short explainer video to learn more about the directive, and more specifically about Article 11 and Article 13.
Views: 4379 EURACTIV
The Medical Device Regulation MDR replaces both, the Medical Device Directive (MDD, 93/42/EEC) and the Directive for Active Implantable Medical Devices (AIMDD). This video gives an overview on the 5 most relevant changes the MDR introduces. These changes include 1. Conformity assessment procedures 2. Classification 3. Essential requirements - General safety and performance requirements 4. UDI & EUDAMED 5. Post-Market requirements The Johner Institute helps medical device manufacturers to fast and easily navigate the approval processes, to fulfill the MDR requirements and to obtain the CE mark. Complimentary consulting on www.johner-institute.com.
Views: 6994 Johner Institute
The European Union’s Medical Device Regulation (MDR) is in place. What does it mean for device manufacturers? MasterControl and UL (Underwriters Laboratories) present a free webinar featuring industry expert Linda Chatwin, who breaks down the new regulation and offers practical tips.
Views: 11383 MasterControl
Direct effect allows rights under EU law to be enforced within a domestic court system. Vertical direct effect allows rights to be enforced against an emanation of the state while horizontal direct effect allows rights to be enforced against other individuals or against companies. Direct effect is also conditional on the type of EU law that is being enforced. Treaties are a form of primary legislation and have vertical and horizontal direct effect so long as the relevant treaty article matches the conditions set out in Van Gend en Loos (1963): Clear and unconditional Prohibition Not dependent on member state implementation Regulations are directly applicable and as such also have vertical and horizontal direct effect. Directives, in principle, only have vertical direct effect because they are an obligation for member states to implement them. Even then they can only be enforced when they grant rights to individuals (Defrenne v SABENA (No. 2) (1979)) and the time limit for implementation has passed (Pubblico Ministero v Ratti (1979)). However there is a way that directives can have horizontal direct effect and this is known as indirect effect. This works because the courts themselves can be considered as emanations of the state and so in their judgments have to enforce EU law between individuals. This concept first arose in Von Colson v Land Nordrhein-Westfalen (1984) and was applied in the UK through Lister v Forth Dry Dock . An emanation of the state was defined in Foster v British Gas plc  as a body that: Provides a public service Under the control of the state Has special powers beyond those of individuals
Views: 38947 marcuscleaver
This video gives a short yet comprehensive explanation of the regular yet complicated way new EU law is made (the Ordinary Legislative Procedure). It sheds a simplified light on the process as a whole, the main actors and some of the possible complications. For more information on the EU and its institutions please subscribe to our channel. In this series we explain complex aspects of the EU in a comprehensive and understandable way. If however, despite our diligence and help of Dr. Jan Oster, we have left something out or made a mistake, please be so kind to tell and forgive us. -------------------------------------------------- With Ciceroni we seek to be a guide to European culture and history. We make videos on little known subjects as well as more ubiquitous ones, ranging from current affairs like the European Union, to historic events like the Tulip Mania, and even mythological stories like those of the Greek Gods. In all these videos we strive to present the subjects in a objective manner and within their complex context. Become a Patron: https://www.patreon.com/Ciceroni Follow us on Twitter: https://twitter.com/Ciceroni_EU Like us on Facebook: https://www.facebook.com/CiceroniChan...
Views: 61579 Ciceroni
www.janalbrecht.eu www.greens-efa.eu/ www.gef.eu Idea by Jan Philipp Albrecht MEP Concept & Realisation by www.annalenaschiller.com +Team Concept+Design: Anna Lena Schiller Eli Breuing Project management: ahoihochzwei - Iris Börgerding Voiceover: Will Rolls Sound: The SoundShack GmbH Set Assistant: Arne Schiller
Views: 39631 Jan Philipp Albrecht
This video introduces the Europan medical device regulations, in particular the Medical Device Regulation MDR, the conformity assessment procedures (sometimes referred to as "certification process") and the medical device classification. It explains when an ISO 13485 certified quality management system is required and which are the most relevant documents manufacturers have to compile
Views: 3440 Johner Institute
For those privacy professionals out there - everything you REALLY need to know about the new EU General Data Protection Regulation in 60 minutes (or thereabouts).
Views: 90350 Phil Lee
SIEMIC Website: http://www.SIEMIC.com Email: [email protected] Phone Number: 408 - 526 - 1188 Location: 775 Montague Expressway, Milpitas, CA 95035 Ukraine Ministry of Economic Development and Trade website: http://www.me.gov.ua/
Views: 100 SIEMIC Global Testing & Certifications
On 26 September 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council on medical devices and in vitro diagnostic (IVD) medical devices. These regulations, once adopted, will replace the existing three medical devices directives (MDD, AIMD, IVD). The MDD and AIMD will be incorporated into one single regulation, the MDR. For current IVD directive, the new regulation will be the IVDR. The new Medical Device Regulation affected all kinds of medical devices, from home-use items like sticking plasters and contact lenses, to X-ray machines, pacemakers, breast implants and hip replacements. The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. Ensuring compliance to the new regulations is critically important for legal manufacturers in order to CE mark their devices in Europe. Manufacturers however will also benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation. The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.
Views: 9359 TÜV SÜD Product Service UK
NEW DATA PROTECTION REGULATION FOR EU INSTITUTIONS AND BODIES - ANOTHER PIECE OF THE PUZZLE. Chair: Cornelia Ernst, MEP (EU) Moderator: Vagelis Papakonstantinou, VUB-LSTS (BE) Speakers: Diana Alonso Blas, Eurojust (EU), Elena Gil Gonzalez, CEU San Pablo University/IVIR (ES/NL), Juraj Sajfert, DG JUST (EU); Christina Samaras, Cleary Gottlieb Steen & Hamilton LLP (FR); Wojciech Wiewiorowski, EDPS (EU) On 11 December 2018, almost two years after the Commission presented its proposal, the new data protection Regulation for Union institutions and bodies (EU) 2018/1725 entered into appli- cation, replacing the Regulation (EC) No 45/2001. The new Regulation aligns the data protection regime for Union institutions and bodies with the GDPR and the Data Protection Law Enforce- ment Directive (EU) 2016/680. At the same time, and after five years of legislative negotiations, the new Eurojust Regulation entered into force and will apply from 12 December 2019. With these two brand new legislative instruments, in 2019 Eurojust will become the first EU law enforcement agency that does not have an autonomous, standalone data protection regime. • What is the meaning of all these changes? Why a separate Regulation for Union institutions and bodies? • What are the differences between the new Regulation and the GDPR/Data Protection Law Enforcement Directive? • What are the EU law enforcement agencies? Do e.g. Frontex or the EU Common Defense and Security Policy missions have law enforcement tasks? What is a law enforcement task? • Do EU law enforcement agencies need even more specific data protection rules than the GDPR/Data Protection Law Enforcement Directive, and if yes, why?
Views: 412 CPDPConferences
An examination of judicial review and the relevant procedure under EU law and in particular articles 263, 264 and 265. Firstly there has to be a binding piece of secondary legislation such as a regulation, directive or decision and not a recommendation or opinion as these are not binding. A review has to be brought within two months of publication in the Official Journal or two months from when the applicant first new about the act. There are four grounds of review: Lack of competence (Germany v EP & Council  (Tobacco advertising case)) Infringement of an essential procedural requirement (Roquette Frères v Council ) Infringement of the Treaty or any rule of law relating to its application (Hautala v Council ) Misuse of power (UK v Council (Re. Working Time Directive) ) Locus standi for privileged applicants such as the European Council, European Commission, European Parliament and Member States is automatic. Semi-privileged applicants such as the European Central Bank, the Court of Auditors and the Committee of Regions can also challenge legislation when it affects their prerogaative. Challenging legislation through judicial review is much harder for non-privileged applicants as they can only challenge three types of act: An act addressed to that person An act of direct and individual concern A regulatory act of direct concern with no implementing measures The interpretation of direct and individual concern by the Court of Justice has been very problematic. A person is only directly concerned when they are directly affected by a piece of legislation such as in Société Louis Dreyfus et Cie v. Commission . There can be no intervening discretion exercised by a Member State as was the case in Eridana v Commission . Individual concern is the most controversial area of judicial review since the case of Plaumann v Commission  and the establishment of the Plaumann test. The idea of a fixed, closed class has been interpreted so narrowly as to be almost meaningless. In fact it almost only ever applies retrospectively as in the case of Alfred Toepfer v Commission . There have been attempts to ameliorate the effects of Plaumann such as the abstract terminology test of Calpak  but this had little practical effect despite claiming to look behind the form to the substance of a piece of legislation. Codorniu  took Calpak to its logical conclusion but unfortunately has never been followed. Attorney-General Jacobs in Unión de Pequeños Agricultores (UPA) v Council  suggested an alternative test based on whether the legislation had a substantial, adverse impact on the applicant but this was rejected in that case itself as well as in Jégo-Quéré . The actual meaning of the final type of act (A regulatory act of direct concern with no implementing measures) is still unclear since the Lisbon treaty but both Inuit v EP & Council  and T&L Sugars v Commission  shed some light and suggest the insertion does not break new ground beyond Plaumann. Article 264 empowers the court to annul a piece of legislation if a successful challenge is brought by an applicant. Article 265 is the converse to article 263 and allows a challenge for failure to act. However there has to be a duty to act (European Parliament v Commission ) but the legislation must have been addressed to that person (Lord Bethel v Commission ). Even if the applicant is successful the institution can respond by simply defining its position. An alternative for non-privileged applicants is to use art 267 (the preliminary reference procedure) but this has its own risks. An applicant has to break the law to bring the challenge and it is not certain that a court will make a reference to the CJEU.
Views: 15601 marcuscleaver
The origin of the proposed regulations dates back to 2008: The Medical Device Regulation and the In Vitro Diagnostics Regulation were initially proposed in 2008 when the EU commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was first released by the European commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current medical device directive (93/42/EEC), the EU’s directive on active implantable medical device (90/385/EEC), and the In Vitro Diagnostic directive 98/79/EEC. The final publication for both regulations is expected for no later than May 2017. The manufacturers will phase out from the respective directives governing their currently approved medical devices through a transition period of three years and fully embrace the requirements of the MDR, which will take full effect in 2020.The same is expected for In Vitro Diagnostic Medical Device Manufacturers with a transition period of 5 years, and the IVDR becoming enforceable by the end of 2022.
Views: 1116 GMED
The REACH Regulations replace a number of directives with a single system EU regulation concerning the registration, evaluation, authorisation and restriction of chemicals. The Regulations are in place to provide a high level of protection to human health and the environment from the use of chemicals and to make the people who place chemicals on the market responsible for understanding and managing the risks associated with their use.
Views: 4116 3M UK & Ireland
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Views: 175172 Black Pigeon Speaks
Medical Device Regulation Training - Within less than 10 minutes you'll learn how to classify a Medical Device in Europe with the new Medical Device Regulation MDR 2017/745. This step is important for the Medical Device Industry. I'll tell you How many classes it exists, why this is important. I'll also inform you about all the rules that exist and in the end, you'll have some exercises to test your knowledge. I will also provide you with a free form to download so you can be more efficient when you'll have to classify your product. Look at the notes below for the link *************************** Links ************************** - Participate to the free Mini-Course on MDR 2017/745 (6 days challenge) https://easymedicaldevice.com/mdr - Free Form to classify your medical device https://easymedicaldevice.com/class - Article on Medical Device Classification in Europe https://easymedicaldevice.com/mdclass ------------------------------------------------------------------------------------------- Social Media to follow Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice -------------------------------------------------------------------------------------------- Monir El Azzouzi Easy Medical Device #medicaldevice #medtech #regulation
Views: 1707 Easy Medical Device
State liability is slightly different from direct effect because rather than suing an emanation of the state they are suing that member state itself. We know that directives have vertical direct effect but not horizontal direct effect especially when there is no national law in place. In the case of Francovich this was a real problem as he wanted to enforce his rights against a bank which was a private entity. When this wasn't possible he instead decided to sue the state directly and the European Court of Justice allowed this when the following conditions are met: The directive gives rights to individuals The rights are identifiable within the directive Causal link between the failure to implement the directive and the damage suffered Francovich concerned the non-implementation of directives but in Brasserie du Pêcheur and Factortame  it was applied in relation to all forms of EU law although the condition was added that the breach must be sufficiently serious State liability can come up as an essay question in terms of how liable the state is for the actions of the judiciary but is also likely to come up indirectly regarding questions of article 258 and the enforcement of Community law.
Views: 17269 marcuscleaver
The Commission published a proposal in January 2017 for a new e-Privacy 'regulation. The aim is to reform the existing 2002 legislation to adapt the e-Privacy rules to the new technological reality, and to align them to the 2016 General Data Protection Regulation (GDPR). Stakeholders are divided on certain issues, including on the basic need for a new measure to protect confidentiality in e-communications. Subscribe to EPRS Policy Podcasts: http://www.europarl.europa.eu/rss/en/audio-podcasts.html See the paper publication behind this podcast: http://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2017)608661
Views: 850 European Parliamentary Research Service
My recent webinar with DataGuidance on the impact of the e-Privacy Regulation on the future of digital marketing, including targeted advertising and e-mail and phone marketing, with Noga Rosenthal from Epsilon and Matthias Matthiesen from IAB Europe. Includes a discussion on the IAB's Transparency and Consent Framework.
Views: 998 Phil Lee
On 21st of April of 2018, this new PPE Regulation came into force, replacing the old PPE Directive. This Directive has followed the PPE market for over two decades. Given the great importance of PPE in the safety and protection of its users, there was a need to have a legal instrument to impose clear rules to the Member States of the European Union. If you work in the PPE market, use or purchase PPE, we advise you to read the new regulation and understand all of these changes. FALL SAFE® products are submitted to rigorous quality tests and we guarantee that we will comply with all requirements to offer you maximum safety. Thank you for watching us, if you have any question or feedback, please share it with us by email [email protected]
Views: 97 FALL SAFE
"New Approach" Directives set out the essential requirements, written in general terms, which must be met before products may be sold in the European Community. European harmonised standards provide the detailed technical information to meet the essential requirements. For more information about CE marking visit our website: http://www.tuv-sud.co.uk/uk-en/activity/product-certification/european-approvals/ce-marking
Views: 2936 TÜV SÜD Product Service UK
The new EU copyright law is going to have drastic affects on the freedom and openness of the Internet. Beyond banning memes, Article 13 of the European Copyright Directive 2018 will result in automated surveillance and centralized control of the Internet. The directive makes online platforms liable for the content generated by their users. That means that on top of punitive and vaguely worded terms of services, Internet gate-keepers like Facebook, Google, or Twitter will be required by law to proactively monitor and censor content. These online platforms will be required by law to create automated mechanisms to filter infringing content. Such technology would essentially turn into “upload filters”. These automated filters won’t be recognizing between infringing and legitimate content, like parodies, satire, commentary or other instances of fair use. To balance the flaws of automated upload filters, the directive also requires platforms to build staffed systems for filing complaints for illegitimate takedowns. I make these videos because I believe standing up against power and illegitimate authority is a moral duty. I believe all humans are fundamentally free. But this freedom won't take care of itself. If you too believe this cause and want to help in this pursuit, you can donate to any of my cryptocurrency wallets. Bitcoin: 1C7UkndgpQqjTrUkk8pY1rRpmddwHaEEuf Dash Xm4Mc5gXhcpWXKN84c7YRD4GSb1fpKFmrc Litecoin LMhiVJdFhYPejMPJE7r9ooP3nm3DrX4eBT Ethereum 0x6F8bb890E122B9914989D861444Fa492B8520575 Credits: Music 'A System of Numbers' by CO.AG music https://www.youtube.com/channel/UCcavSftXHgxLBWwLDm_bNvA Sources: Text of the EU Copyright Directive https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52016PC0593 EFF on the EU Directive https://www.eff.org/deeplinks/2018/09/today-europe-lost-internet-now-we-fight-back https://www.eff.org/deeplinks/2018/09/fake-compromises-real-threats-next-weeks-eu-copyright-vote https://www.eff.org/deeplinks/2018/09/new-copyright-powers-new-terrorist-content-regulations-grim-day-digital-rights https://www.eff.org/files/2018/06/13/article13letter.pdf News Coverage https://www.theverge.com/2018/9/12/17849868/eu-internet-copyright-reform-article-11-13-approved http://www.europarl.europa.eu/news/en/press-room/20180906IPR12103/parliament-adopts-its-position-on-digital-copyright-rules https://www.theverge.com/2018/6/19/17480344/eu-european-union-parliament-copyright-article-13-upload-filter https://www.theverge.com/2018/6/20/17482554/eu-european-union-copyright-filter-article-11-13-passes-juri-vote https://arstechnica.com/tech-policy/2015/07/new-study-shows-spains-google-tax-has-been-a-disaster-for-publishers/ https://www.politico.eu/article/plan-to-make-google-pay-for-news-hits-rocks-copyright-reform-european-commission/ https://www.politico.eu/interactive/copyright-reform-power-matrix-gunther-oettinger-european-commission-eu-policy/ https://www.theguardian.com/technology/2018/jun/20/eu-votes-for-copyright-law-that-would-make-internet-a-tool-for-control https://www.theguardian.com/technology/2018/jun/20/music-industry-wins-key-vote-in-youtube-copyright-battle https://www.theguardian.com/business/2017/apr/15/music-industry-youtube-video-streaming-royalties https://www.bloomberg.com/news/articles/2018-09-20/silicon-valley-and-publishers-fight-on-after-eu-copyright-vote https://www.billboard.com/articles/business/8474706/eu-copyright-vote-music-sector-final-lobbying-push https://qz.com/1387581/article-11-the-eus-copyright-law-could-give-publishers-power-over-google-and-facebook/ https://qz.com/1389385/article-11-and-article-13-axel-voss-is-surprised-by-eu-copyright-law/ Opposition https://juliareda.eu/eu-copyright-reform/censorship-machines/ https://juliareda.eu/2017/03/study-article13-upload-surveillance/ https://juliareda.eu/wp-content/uploads/2017/03/angelopoulos_platforms_copyright_study.pdf https://drive.google.com/file/d/0B7NZMlL3kj5qQzN0RXd2Z0JaR1JmemxhNDd2VmgzSjhFQXdj/view https://juliareda.eu/eu-copyright-reform/extra-copyright-for-news-sites/ https://juliareda.eu/2017/04/copyright-reform-kills-eu-startups/ https://www.youtube.com/watch?v=z6EMOTLwYLM https://europeancopyrightsocietydotorg.files.wordpress.com/2015/12/ecs-opinion-on-eu-copyright-reform-def.pdf http://www.locusmag.com/Features/2008/11/cory-doctorow-why-i-copyfight.html Follow me: https://twitter.com/The_HatedOne_ https://www.bitchute.com/TheHatedOne/ https://www.reddit.com/user/The_HatedOne/ https://www.minds.com/The_HatedOne The footage and images featured in the video were for critical analysis, commentary and parody, which are protected under the Fair Use laws of the United States Copyright act of 1976.
Views: 55099 The Hated One
Watch this presentation on the admetrics blog: https://goo.gl/d23var This edition of the digital advertising update looks at the current status of the EU's controversial new ePrivacy regulation, points out the disconnect between legistlators and industry groups and questions the timing of the introduction of ePrivacy. [Related links] https://goo.gl/emTaCg – Primer on ePrivacy by the European Commission: https://goo.gl/YEZYUR – Anti-ePrivacy Campaign Site by Industry Group IAB UK https://goo.gl/LnZkjs – Open letter slamming ePrivacy Proposal by EPC (European Publishers Council) Get in touch if you have any questions: https://admetrics.io/en/contact
Views: 456 admetrics
BOOK REVIEW EU REGULATION OF E-COMMERCE A Commentary Edited by Arno R Lodder and Andrew D Murray ISBN: 978 1 78536 933 9 (Book) 978 1 78536 934 6 (ebook) EDWARD ELGAR PUBLISHING Elgar Commentaries This book is available electronically in the Elgaronline Law subject collection DOI 10.4337/9781785369346 www.e-elgar.com www.elgaronline.com __________________________________________________ PRIOR TO BREXIT: A DETAILED EXAMINATION OF CURRENT E-COMMERCE REGULATION WITHIN THE EUROPEAN UNION An appreciation by Elizabeth Taylor of Richmond Green Chambers and Phillip Taylor MBE, Head of Chambers and Reviews Editor, “The Barrister” As Brexit is still almost two years off, this recent title from Edward Elgar Publishing has attracted considerable interest among lawyers or scholars seeking an enhanced understanding of e-commerce legislation. It presents a compendium of current thinking and commentary from an international team of contributors on, as the title indicates, EU regulation of e-commerce. Having burst upon the international scene in about 1997 or earlier, e-commerce admittedly is no longer a new means of communication, having by now become a key component of global business activity and indispensable in everyday life. This book therefore provides much close analysis of the current regulatory framework of e-commerce within the European Union. It covers a wide range of recent developments in case law and regulation in this now vital area of law, with which all lawyers should now be at least reasonably familiar. We refer here to UK lawyers as well as the international variety, despite, or perhaps even because of, the imminence of Brexit. It’s expected that nothing much will change immediately, but be warned. We shall feel a longer-term impact on e-commerce as Brexit bites. This latest title in Elgar’s “Commentaries” series is therefore very welcome, as editors Arno R Lodder and Andrew D Murray set out to provide a complex and detailed examination of current EU e-commerce regulation via specially commissioned articles from their contributors, all leading scholars and practitioners from across the EU. Murray, for example, is Professor of Law at the London School of Economics, focusing on new media and technology law. Lodder is Professor of Internet Governance and Regulation at Vrije Universiteit Amsterdam, the Netherlands. The book contains coverage of the key pieces of EU legislation pertaining to e-commerce, including the E-commerce Directive, the Services Directive, the Consumer Directive, the General Data Protection Regulation, and the eID Regulation. For the convenience of practitioners, the book very sensibly follows the format and time-saving features of the traditional legal text, including tables of cases and legislation, numbered paragraphs throughout, an extended table of contents and a detailed index. The extensive footnoting provides any number of references for keen researchers. This book will certainly serve as a useful addition to the professional library of the legal scholar, as well that of the informed practitioner seeking enriched and insightful analysis into this fast-developing and increasingly complex area of law. The publication date is cited as at 2017.
Views: 278 Phillip Taylor
The revised payment services directive, PSD2, will require banks and third party service providers to adapt to new competition and rules. Learn more in this video. You will find more information on our website: https://www2.deloitte.com/lu/en/pages/banking-and-securities/articles/psd2-revised-payment-services-directive.html
Views: 19213 Deloitte Luxembourg
The distinction between establishment and services is based on the idea that establishment is more permanent whereas services are more temporary in nature. Establishment mainly falls under Art. 49 with 49(1) allowing for primary and secondary establishment and (2) prohibiting unequal or discriminatory treatment. The law in this area is directly effective as per Reyners . Equivalent qualifications across member states are interpreted broadly as per Heylens  and also Directive 2005/36 Meanwhile article 49(2) has been broadened beyond discrimination to include any unjustified restriction on the freedom of establishment. The main case in this are is Gebhard  that allows for restrictions only if they meet four criteria: 1) Non-discriminatory 2) Justified 3) Needed to secure an objective 4) Don't go beyond what is necessary to achieve that objective A national can rely on Art. 49 with respect to their own member state only when they have exercised the freedom of movement themselves as per Knoors  Article 54 states companies should be treated in the same way as individuals and although company law can vary from state to state the ECJ has placed a lot of focus on achieving the overall objective of freedom of establishment as seen in Centros  and Überseering . However once a company is established in a Member State they are then subject to that country's rules as regards incorporation etc. as per Daily Mail  and Cartesio  The liberalisation provided by Art. 54 means that it can be difficult to crack down on tax avoidance as seen in Cadbury Schweppes . Freedom of services is based on the temporary nature of the work rather than the infrastructure or, as per Commission v Portugal , the period of time. Art. 57 loosely defines services and 58 excludes other services that are covered in other parts of the treaty. Art. 56 also has direct effect as per Van Binsbergen . Similarly there also has to be an inter-state element as seen in Deliège  Also covered is the freedom to receive services; Luisi & Carbone  The service does have to be provided for remuneration and this line can become blurred in relation to certain healthcare systems that are a hybrid between user and government payments Some controversial services such as abortion, gambling and marijuana can still be considered services (Grogan ) but can be subject to national rules that provide a proportional and non-discriminatory restriction (Zenatti ). Taking a broad definition it is even possible that certain social benefits may also fall within the definition; Cowan . Art. 62 allows for restrictions on policy, security and health grounds. Beyond this Van Binsbergen  sets out the conditions for any restriction imposed by a Member State: 1) Pursuit of a legitimate public interest 2) Applied without discrimination 3) Proportionate 4) Respects fundamental rights (Carpenter ) This freedom can be controversial as it allows greater liberalisation in the labour market at the expense of employee rights. This came to a head in Laval  although this judgment has been tempered somewhat by the Rome I Regulation. Restrictions on tax grounds can be allowed to prevent fraud but not for other, broader reasons; Danner . Non-discriminatory restrictions can also be caught if they are a hinderance to the freedom of services (Alpine Investments ) and Gebhard  also applies within this context. The Bolkenstein Directive sought to achieve greater harmonisation by focusing on the country of origin but after protest this was watered down and so only mainly deals with a range of procedural and administrative issues.
Views: 10780 marcuscleaver
Presentation from Scott Pharma Solutions Ltd on EU Regulation No 536/2014 and EMA Policy/0070. Global Publication Planning 2017: The Challenges of Publishing in an Era of Increased Disclosure, held in Basel Switzerland on 6th November 2017. Publications professionals attended this free one-day seminar, designed specifically for the pharmaceutical industry. The event was a unique opportunity to hear from industry peers about the latest disclosure requirements and policies, the responses to these changes and the implications and impact upon working practices, including data sharing and layperson summaries. In addition to formal presentations, we held smaller breakout sessions around engaging with authors and raising the profile of publications within the organisation. Ensure you register for future free events at http://howtopublishresearch.com/events/
Views: 281 inScience Communications
The upcoming European Union (EU) Medical Device Regulation (MDR) will replace the Medical Devices Directive and the Active Implantable Medical Devices Directive. Travis Miller, Assent’s General Counsel, will discuss the new requirements under the regulation and what companies need to do to prepare their programs. Topics to be covered in this webinar include: - The differences between the EU MDR and the directives it will replace - Reporting requirements under the EU MDR - How to update technical documentation to comply - Which processes to implement to meet the new requirements
Views: 267 Assent Compliance
Hear Nathan Shipley, BSI’s Certification Manager, talk about the PPE Directive landscape and the changes to expect in Regulation scope, categories and modules. Look at the latest timescales for the changes and how you can prepare your business for them. To learn more visit: https://www.bsigroup.com/en-GB/our-services/product-certification/industry-sector-schemes/personal-protective-equipment-ppe/PPE-regulation-revision-uk/ Connect with BSI: Follow BSI on YOUTUBE: http://bit.ly/BSIYouTubeSubscribe Follow BSI on LINKEDIN: http://bit.ly/BSILinkedInHome Follow BSI on TWITTER: http://bit.ly/BSITwitterFeed Follow BSI on FACEBOOK: http://bit.ly/BSIFacebookTimeline
Views: 299 BSI Group
Strasburg 11.03.2014: Protection of individuals with regard to the processing of personal data http://www.europarl.europa.eu/ep-live/en/plenary/video?debate=1394551834561&streamingLanguage=en This channel is not about any particular person, name, face or political party. We prefer to focus on the content rather than the people behind it. We want to show and discuss recent social developments in a creative way and create an alternative media platform. In consideration of the speed and the overload of events in our time, we want to raise awareness of the consequences of current processes for our future. Everyone has his or her own interests, we want bring them together, because EVERYTHING IS A REMIX. Visit us: on our Homepage: www.goveto.org on facebook: http://www.facebook.com/goveto follow on twitter: http://www.twitter.com/go_veto share on diaspora: http://www.tinyurl.com/diasporagoveto g+: https://tinyurl.com/plusGoVETO instragram: https://instagram.com/goveto
Views: 552 GoVeto
Medical Device Regulation Training - What is a Medical Device in Europe? The new Medical Device Regulation EU MDR 2017/745 change the definition of a Medical Device. Now there is more clarity in terms of some additional functions, products. Bonus: I will also share with you the new products on the scope of the Medical Device Regulation even if they have no Medical Purpose. -------------------------------------------------------------------------------------------- Article: "Definition: What is a Medical Device?" https://easymedicaldevice.com/2018/03/medical-device-definition/ Free Mini-Course MDR 2017/745 - https://easymedicaldevice.com/resource-medical-device-regulation/mini-course-mdr/ If you really want to test if your product is a Medical Device, use our free tool. https://easymedicaldevice.com/is-my-product-a-medical-device/ -------------------------------------------------------------------------------------------- Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevices/ Instagram: https://www.instagram.com/easymedicaldevice/ Monir El Azzouzi Easy Medical Device #medicaldevice #medtech #regulation
Views: 1072 Easy Medical Device
Organised by CPDP Chair: Franziska Boehm, FIZ Karlsruhe – Leibniz Institute for Information Infrastructure (DE) Moderator: Katarzyna Szymielewicz, Panoptykon (PL) Panel: Jaroslaw Lotarski, DG Home (EU), Vagelis Papakonstantinou, Brussels Privacy Hub (BE), Juraj Sajfert, DG Justice (EU), Eric Töpfer, Institut für Menschenrechte (DE) The Directive on protecting personal data processed for the purpose of criminal law enforcement (EU 2016/680) entered into force on 5 May 2016. This Directive aims to protect the right of individuals to the protection of their personal data while guaranteeing a high level of public security. Member States have until 6 May 2018 to implement its provisions into national law. Discussions about the principles set out by the Directive and their practical consequences for various policies pursued by the Member States were put into the shade of the GDPR. While it includes some new obligations that Member States shall impose on data controllers (e.g., data protection impact assessment, transparency requirements, a designation of a DPO), it also provides for broad exemptions and a possibility to adopt legislative measures restricting individuals’ rights. Following up on this insight, the panel will address the following questions: What problems could arise from the fact that EU data protection law is not applicable to the processing of personal data for the purposes of national security? What impact will the Directive have on secret surveillance measures and mass surveillance operations pursued by Member States? In the light of increased transparency requirements for data controllers, will European citizens gain more insight into public policies that affect their rights and freedoms? How might the Directive affect the scope and transparency of public policies that rely on profiling and involve automated decision making?
Views: 711 CPDPConferences
Jan Philipp Albrecht (Greens/EFA, Germany): Rapporteur for the Regulation (http://en.wikipedia.org/wiki/Jan_Philipp_Albrecht, http://www.janalbrecht.eu/home.html) Dimitrios Droutsas (S&D, Greece): Rapporteur for the Directive (http://en.wikipedia.org/wiki/Dimitrios_Droutsas, http://www.europarl.europa.eu/meps/en/107977/DIMITRIOS_DROUTSAS_home.html) Regulation: http://en.wikipedia.org/wiki/Regulation_(European_Union), http://ec.europa.eu/eu_law/introduction/what_regulation_en.htm Directive: http://en.wikipedia.org/wiki/Directive_(European_Union), http://ec.europa.eu/eu_law/introduction/what_directive_en.htm) http://www.europarl.europa.eu/news/en/news-room/content/20131021IPR22706/html/Civil-Liberties-MEPs-pave-the-way-for-stronger-data-protection-in-the-EU This Channel is not about any particular person, name, face or political party. We prefer to focus on the content rather than the people behind it. We want to show and discuss recent social developments in a creative way and create an alternative media platform. In consideration of the speed and the overload of events in our time, we want to raise awareness of the consequences of current process for our future. Everyone has their own interests, we want bring them together, cause EVERYTHING IS A REMIX follow on facebook: https://www.facebook.com/GoVeto find us on wordpress:http://gooutsidewien.wordpress.com/ follow on twitter: @Go_VETO share with us on diaspora: https://pod.geraspora.de/u/gooutsideveto on instagram: http://instagram.com/goveto on g+: https://tinyurl.com/plusGoVETO
Views: 246 GoVeto
Help save the internet: https://saveyourinternet.eu/ #DeleteArt13 In this video I'm discussing the new Copyright law & Link tax proposed by the European Parlament: Article 13. It will result in immense censorship of everything online, memes will be banned, YouTube creators will suffer greatly & much more. Link to the law document: http://ec.europa.eu/transparency/regdoc/rep/1/2016/EN/1-2016-593-EN-F1-1.PDF
Views: 29061 Christian Nielsen
For 10 years, chemical companies have assessed the risks of their chemicals used in Europe and sent that information to the European Chemicals Agency according to the criteria set out in the REACH Regulation. Today, we know more than ever before about the chemicals on the EU/EEA market, their properties and impacts. Companies are able to advise their customers on how to use them safely. ECHA together with the national authorities and the European Commission will use the knowledge to design EU wide measures to protect our citizens and the environment from any harmful effects. Find out more: https://echa.europa.eu/reach-2018/
Views: 3290 EUchemicals
Susan Grieve, Principal Pharmacist, Department of Health
Views: 1077 GS1UK
If a company manufactures a product in the hope of accessing the European Union market, it is likely they will eventually encounter the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH). Complying with REACH can be a challenge for many companies, as its requirements are ever-changing and new substances of very high concern (SVHCs) are regularly added to its list of restricted substances. In order to stay ahead of this evolving regulation, companies must implement an agile compliance program which can adapt to change while meeting rigorous regulatory obligations. In this video, join Valerie Kuntz, Assent’s Subject Matter Expert on restricted substances, as she explores the REACH Regulation and provides key insights companies can use to create strong compliance programs. In this webinar, you will learn: -What the REACH Regulation is -What are the regulation’s main compliance requirements? -What is the SVHC Candidate for Authorisation List? -… and more! REACH compliance requires companies to access their supply chain and collect vital product composition data, analyze the information and ensure they meet the regulation’s thresholds. This video provides the opportunity to learn more about REACH, understand its requirements and how you can comply with the regulation. Learn about Assent's REACH SVHC Module here: http://www.assentcompliance.com/reach-module/ Learn about Assent's Product Compliance Suite here: http://www.assentcompliance.com/product-compliance-suite/ Experience our events live. Visit the Events page here: http://www.assentcompliance.com/events/
Views: 5032 Assent Compliance
Quocirca Service Director Bob Tarzey presents his nomination of the EU Data Protection Directive as a Security Change Agent. Read Bob's full nomination below or at http://www.digitalguardian.com/about/security-change-agents/eu-data-protection-directive. Setting the Agenda for Information Security in Europe by Bob Tarzey, Analyst and Director, Quocirca For better or for worse, Quocirca believes the most important Security Change Agent effecting IT decision making in Europe is the EU Data Protection Directive. It affects not just people and business within the EU, but those living beyond its boundaries that transact with the world’s largest single trading block. The legislation is passed down by the European Commission with its president and 28 commissioners representing each of the member states. The Commission first passed the Directive in 1995 in response to the growing use of the internet. It incorporates the seven principles for the protection of personal data first laid out by the OECD (Organization for Economic Cooperation and Development) in 1980. It provides guidance on the storage, movement and processing of personal data regarding European citizens. As a directive it is not mandatory but many aspects of it have entered the laws of individual countries. At its core is the principle that the processing of personal data should be transparent, legitimate and proportional. For example, a bank should not collect data about a person’s religion if all it is doing is providing a loan and the individual should know what data is being collected and that the data will be adequately protected. In 2012 a process was put in place to upgrade the directive to a regulation, an on-going process that may take years. When this completes it will be mandatory rather than optional for member states. As well as strengthening core principles, especially those around disclosure, the regulation will significantly increase the fines applicable to a business that breaches the rules. Furthermore, the rules are being reinforced all the time through the courts, such as the 2014 ruling by EU Court against Google confirming the “right to be forgotten”. So why is dry-sounding legislation the most important Security Change Agent to come out of Europe? It is less the directive itself, but the debate it inspires. No security vendor’s presentation is complete without warnings about the EU DP law and how the vendor can help prospective customers comply. No return on investment calculation, however flawed, is complete without adding on the cost of potential fines that are helpfully set to increase. And it is not just security vendors; a key tenet of the law is that European citizens’ data must be stored within the EU unless safe harbour agreements are in place. This has forced every cloud-based service provider to think about the way it plans infrastructure investment and trades in the EU. More than any black-hat or security guru, EU DP law is setting the agenda for information security in Europe and for those that wash up on its shores.
Views: 391 Digital Guardian
Cookies, unsolicited direct marketing messages, processing of location data http://www.privacylaws.com Speaker: Jos Dumortier, time.lex - information & technology law, Brussels Recorded at the Privacy Laws & Business 28th Annual International Conference Privacy in a Connected World 6 - 8 July 2015, Cambridge, UK http://www.privacylaws.com
Views: 274 Privacy Laws & Business
In this video I explain HGV drivers hours and working time directive basics that will keep you legal. these rules can be very complicated so i try to break them down and hopefully easier to understand. this isn't comprehensive but is enough to get you through a working week as a new driver. I go through maximum daily driving, daily breaks, daily rest, weekly rest and working time directive including daily and weekly driving, working breaks, holiday and night shift health checks. I'm a Class 1 articulated lorry driver, after becoming bored with 9-5 office work I started my HGV training in December 2015 and received my HGV licence in February 2016 including the certificate of professional competence (CPC) and I can safely say it was a great decision. I currently work for The Watercress Company delivering fresh watercress around the country in a refrigerated articulated lorry. Every job is different but in these video's I try to give you an insight into my experience as a HGV driver. Instagram: https://www.instagram.com/kevteetrucking Twitter: https://twitter.com/kevteetrucking Facebook: https://www.facebook.com/kevteetrucking Email: [email protected] Music: John Kenza - Wicked https://www.youtube.com/watch?v=rKCry-BpFT4&feature=youtu.be • https://instagram.com/johnkenza/ • http://facebook.com/johnmusicofficial • https://twitter.com/JohnKenza • https://www.youtube.com/channel/UC471...
Views: 34518 KevTee
On 5th April 2017, the European Parliament voted to adopt the long-awaited Medical Device Regulation (MDR) The MDR regulation will replace the current medical device directive (MDD) and the active implantable medical device directive (AIMD). In this Webinar, we will focus on key changes of MDR and Transition Period Key talking points • Key Changes in New Medical Device Regulation (MDR) • CE Marking Process • MDR and Transition Period This webinar will help you to consider necessary action required to be prepared for the change in requirements of standard as well as planning of CE Marking.
Views: 477 stanley yeo
http://www.ukipmeps.org | http://www.ukip.org • European Parliament, Strasbourg, 11 June 2013 • Speakers: Paul Nuttall MEP, UK Independence Party (North West), Europe of Freedom and Democracy (EFD) group • Debate: Food intended for infants and young children and food for special medical purposes Recommendation for second reading: Frédérique Ries (A7-0191/2013) Recommendation for second reading on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 [05394/1/2013 - C7-0133/2013 - 2011/0156(COD)] Committee on the Environment, Public Health and Food Safety .................... • Video: EbS (European Parliament) .................................. • EU Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom
Views: 590 UKIP MEPs
Designed to introduce the WEEE Regulations in an easy to understand way - jargon free! Find out more at www.complydirect.com
Views: 3031 Comply Direct
Short clip from the Brexit Movie https://www.youtube.com/watch?v=X2PIq3eKXzI 5 Regulations for pillow cases, 109 for pillows, 11 for radio alarm clocks, 225 for glasses, 10 for duvets, 39 bed sheets, 65 for bathrooms, 31 for toothbrushes, 47 for toothpaste, mirrors 172, shower 91, 118 shampoo, towels 454, 36 radiators, 1246 bread, 52 bread toaster, 84 fridges, 12,653 milk, 99 bowels, 210 spoons, 202 orange juice, 625 coffee, 556 dogs, 92 footpaths, Debunking Fake Facts from the In Campaign https://www.youtube.com/watch?v=d73ayPb8VDM The Brussels Business - Who Runs the EU https://www.youtube.com/watch?v=Nd4bY7G7uUY Ten Consequences of a Remain Vote https://www.youtube.com/watch?v=mnQVUtHo2o0 Wikileaks on TTIP https://www.youtube.com/watch?v=DTBsclC2gAA Whos Funding the EU In Campaign https://www.youtube.com/watch?v=FPBrrK-qdeo The EU Bad for Your Money https://www.youtube.com/watch?v=kUNbpaIuFAk The Expense of the EU https://www.youtube.com/watch?v=w-wyDrvDe8s
Views: 2388 NicosMind