To help organizations stay on top of the main developments in European digital compliance, Morrison Foerster’s European Digital Regulatory Compliance team reports on some of the main digital regulatory and compliance...more
2/5/2024
/ Artificial Intelligence ,
Child Pornography ,
Consumer Rights Directive ,
Copyright ,
Critical Infrastructure Sectors ,
Cyber Incident Reporting ,
Digital Marketplace ,
ENISA ,
EU ,
European Parliament ,
General Data Protection Regulation (GDPR) ,
Green Deal ,
Greenwashing ,
Media ,
Member State ,
Online Contracts ,
Online Platforms ,
Parental Consent ,
Political Advertising ,
Popular ,
Strict Product Liability ,
Subscription Services ,
Transparency
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a...more
On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The...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
In November 2021, in its coalition agreement, the newly elected German Federal Government announced its plans to legalize cannabis for recreational use. Since then, it has been hotly debated by the cannabis industry in...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
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
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
The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain...more
3/2/2021
/ Compensation ,
Coronavirus/COVID-19 ,
EU ,
Germany ,
Infectious Diseases ,
Liability ,
Ministry of Health ,
Patents ,
Supply Shortages ,
Third-Party ,
Vaccinations
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 May 1, 2020 the last part of the German Trademark Law Modernization Act (Markenrechtsmodernisierungsgesetz – “MaMoG”), which contains practical relevant amendments to the procedural rules of the German trademark system,...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
The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European...more
The United Kingdom is set to leave the European Union on 29 March 2019 (“Exit Date”). With Brexit fast approaching, on 25 November 2018 the EU and the UK announced their consensus on a withdrawal agreement that sets out the...more
Progress is being made regarding the protection of intellectual property (“IP”) rights in a post-BREXIT scenario on both sides of the English Channel. With BREXIT fast approaching, the European Union (“EU”) and the United...more
Progress is being made regarding the protection of intellectual property (“IP”) rights in a post-BREXIT scenario on both sides of the English Channel. With BREXIT fast approaching, the European Union (“EU”) and the United...more