Medical Device Legal News with Sam Bernstein: Episode 18
JONES DAY PRESENTS®: Harmonizing Global Protections: The EU Trade Secret Directive
The European Union (EU) Artificial Intelligence Act (AI Act), Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending...more
In this blog post, we will focus on the identification of “high-risk AI systems” under the Artificial Intelligence Act (“AI Act”) and the requirements applying to such systems. As explained in our previous blog posts, the AI...more
On 24 January 2024, the European Commission (EC) published its proposed reform of foreign investment screening in the EU. The proposal introduces more comprehensive rules for the review of foreign investments and strengthens...more
Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more
On June 14, 2023, the European Parliament adopted its negotiating position regarding the proposal of the European Commission for a regulation laying down harmonized rules on artificial intelligence. This is the most recent...more
Key Points - The EU aims to harmonize patent protection rules and flexibilities with a layer on top of national rules. This is in line with long-term efforts by the EU institutions to harmonize patent rules and motivated,...more
The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in support of Regulation (EU) 2017/745 (the "Medical Devices Regulation" -...more
Today (25 November 2021) the European Commission (the Commission) released the results of its evaluation of the Alternative Investment Fund Managers Directive (AIFMD) which forms part of a Capital Markets Union legislative...more
On October 13, 2017, the Commodity Futures Trading Commission (CFTC) announced two cross-border developments with the European Commission (EC) that take significant steps toward reconciling regulation of cross-border...more
In 1957, the six EU founding members–Germany, France, Italy, Belgium, the Netherlands and Luxembourg—agreed to settle their conflicts around a table rather than on the battlefields. We are now days away from the 60th...more
The European Commission (EC) announced proposals on 22 November 2016, which are intended to harmonise national insolvency laws across the EU through a proposed directive “on preventative restructuring frameworks, second...more
Regulators in Europe have continued to publish guidance notes designed to encourage the take-up of cloud computing services. As we report in this Alert, the views of the UK financial services regulator on the risks and...more
In May 2015, the European Commission announced its Digital Single Market Strategy to accelerate the creation of a digital single market (DSM) across the EU. The EU’s aim is to broaden access to e-commerce, media and...more
Not all the news coming out of Europe these days is about Brexit. In fact, the forces of unity and harmonization remain a top priority for European regulators hoping to combat digital security threats and create a safer and...more
The European Commission published a status report on progress made since the adoption of the Capital Markets Union Action Plan. The European Commission's Action Plan, published in September 2015, set out the steps for the...more
On 6 May 2015 the European Commission (the "Commission") published its strategy for a 'Digital Single Market' for Europe. The Commission's communication outlines its grand vision for a Europe in which 'the free movement of...more
On 6 May the European Commission released the EU’s Digital Single Market strategy (the ‘DSM Strategy’), with the declared objective to tear down the obstacles to doing business online. The DSM Strategy has been released...more
The European Commission is consulting on a blueprint for creating a harmonised capital market across the EU, to facilitate capital raising in the EU while maintaining consumer and investor protection by simplifying the...more