To help organisations 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 European digital regulatory and...more
4/11/2022
/ Compliance ,
Content Marketing ,
Copyright ,
Copyright Infringement ,
Corporate Counsel ,
Cybersecurity ,
DATA Act ,
Designated Contract Markets (DCMs) ,
Digital Communications ,
Digital Markets Strategy ,
Digital Rights ,
EU ,
European Commission ,
Financial Conduct Authority (FCA) ,
Germany ,
Internet of Things ,
Non-Fungible Tokens (NFTs) ,
OFCOM ,
Online Gaming ,
Online Platforms ,
Popular ,
Proposed Legislation ,
Regulatory Agenda ,
Right to Repair ,
The Copyright Act ,
UK Parliament ,
Video Games
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
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
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
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