Fierce Competition Podcast | Takeaways From the Illumina-Grail Merger Challenge Saga
The EU Corporate Sustainability Due Diligence Directive
The Informed Board Podcast | Will the EU’s Focus on Foreign Subsidies Make It More Difficult To Acquire European Businesses?
EU & UK Competition Law & Public Interest: Best Practices & New Challenges ahead
Nota Bene Episode 135: Europe Q3 Check In: Brexit, Data Protection, and Block Exemption Regulations with Oliver Heinisch
NGE On Demand: Personal Data Protection Travels: The New Standard Contractual Clause with John Koenigsknecht and David Wheeler
Nota Bene Episode 123: Europe Q2 Check In - Brexit Updates and Antitrust Laws in the Digital Economy with Oliver Heinisch
Nota Bene Episode 112: How Europe is Filling Enforcement Gaps for Digital Gatekeepers with Robert Klotz and Ciara Barbu-O’Connor
Nota Bene Episode 106: The Corporate Investor Movement Toward Environmental, Social, and Governmental Policies with Allison Troianos and Ariel Yehezkel
Nota Bene Episode 102: Examining European Union State Aid in the Face of COVID and Brexit with Jacques Derenne and Robert Klotz
What's Next after the Schrems II Decision of ECJ
Compliance Perspectives: The End of the Privacy Shield
Nota Bene Episode 89: European Q3 Check In - Merger Clearance and Data Protection Court Rulings and Brexit Updates with Oliver Heinisch
Podcast: ESMA Report: Undue Pressure on Companies
Nota Bene Episode 65: European Check In: Environmental Protection, Privacy Regulations, Digital Market Definition, and Brexit with Oliver Heinisch
Nota Bene Episode 55: Updates on the European Commission and Brexit with Isabelle Rahman and Oliver Heinisch
Jones Day Talks: EU's New Foreign Direct Investment Regulations Eye Specific Sectors
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
In Short - The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical devices...more
Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023, a proposal (Proposal) to amend the...more
At the end of each year, we have a habit of looking back at lessons learned, the ups, the downs, the works. And like in 2020 and 2021, the COVID-19 pandemic and related shortage of medical devices take center stage in our...more
The European Commissioner for Health and Food Safety, Stella Kyriakides, has proposed measures to extend the transition rules of Medical Device Regulation (EU) 2017/745 (MDR) at the Employment, Social Policy, Health and...more
The implementation of Regulation (EU) 2017/745 on medical devices (MDR) was discussed on the second day of the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on 9 December 2022. The...more
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more
The European Commission has published a Temporary Framework Communication to provide guidance to companies that are cooperating to ensure the supply and distribution of essential products – including medicines and medical...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more
The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more
On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more
The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in...more
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more
On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more
On 9 August 2018, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical...more
On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more