On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into...more
The highly anticipated EU Artificial Intelligence Act is finally here! With extra-territorial reach and wide-reaching ramifications for providers, deployers, and users of Artificial Intelligence (“AI”), the Artificial...more
3/15/2024
/ Artificial Intelligence ,
Copyright ,
Data Mining ,
Data Protection ,
Data Protection Impact Assessments (DPIAs) ,
Enforcement ,
EU ,
European Parliament ,
General Data Protection Regulation (GDPR) ,
Governance Standards ,
Innovative Technology ,
Machine Learning ,
National Security ,
OECD ,
Technology Sector
After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for...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
Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR)...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
6/14/2022
/ Clinical Evaluations ,
Cybersecurity ,
Diagnostic Tests ,
EU ,
Information Technology ,
Life Sciences ,
Manufacturers ,
Medical Device Data System ,
Medical Devices ,
Medical Evaluation Reports ,
Popular ,
Software
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
5/31/2022
/ Certifications ,
Classification ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
EFTA ,
EU ,
European Commission ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Software
After a myriad of challenges, delays, and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an...more
Dr. Schönig, CO2-neutral meat production is considered one of the key aspects in the fight against climate change. Can we really make a big difference through our food choices?
According to expert estimates, conventional...more
UPC – And it got up again-
Having been sent down for the count by constitutional complaints in Germany, the road finally seems paved for the Unified Patent Court. On July 9, 2021, the German Federal Constitutional Court...more
The German patent system has repeatedly proven to provide reliable and effective means to enforce patent rights against infringers. There are three key reasons why the German patent system is so attractive for patentees when...more
The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in...more
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the...more
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device...more
4/12/2021
/ Coronavirus/COVID-19 ,
Data Transfers ,
EU ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Medical Directives ,
Popular ,
Software
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated...more
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more
3/11/2021
/ Analytics ,
Clinical Evaluations ,
Document Retention Policies ,
Documentation ,
EU ,
Life Sciences ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Pharmaceutical Industry ,
Safety Reports ,
Software ,
Supply Chain ,
Surveillance
Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more
2/25/2021
/ Classification ,
Diagnostic Method ,
EU ,
International Medical Device Regulators Forum (IMDRF) ,
Manufacturers ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Mobile Apps ,
Software ,
Software Developers ,
Therapeutic Services
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this...more
Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activities in exchange for fees and the university’s rights to use the...more
On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy for Europe” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The...more
On November 26, the Dusseldorf Regional Court handed down a long awaited decision in the so-called automotive patent wars (case ID 4c O 17/19). The court referred heatedly debated questions in connection with the enforcement...more
12/16/2020
/ Court of Justice of the European Union (CJEU) ,
European Commission ,
Federal Cartel Office (the FCO) ,
FRAND ,
German Federal Supreme Court ,
Germany ,
Huawei ,
International Litigation ,
Nokia ,
OEM ,
Standard Essential Patents ,
Treaty on the Functioning of the European Union (TFEU) ,
ZTE
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU...more
As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnostics, ventilators, and personal protective equipment capable of...more
With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litigation system faces ever-mounting challenges. Last Friday, the...more