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
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 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
ICT standardization is a key part of the European Union’s package of measures designed to improve Europe’s competitiveness and productivity. As part of the EU’s Digital Single Market (DSM) initiative, the European Commission...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
The European Court of Justice (ECJ) rendered its highly anticipated ruling in Huawei v. ZTE on the enforcement of standard essential patents (SEPs) which are subject to a FRAND commitment. SEPs play a significant role in the...more
7/28/2015
/ Abuse of Dominance ,
Anti-Competitive ,
Apple ,
Apple v Samsung ,
Damages ,
ETSI ,
EU ,
European Commission ,
European Court of Justice (ECJ) ,
FRAND ,
Germany ,
Good Faith ,
Injunctive Relief ,
Intellectual Property Protection ,
License Agreements ,
Microsoft ,
Motorola ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Royalties ,
Patents ,
Popular ,
Samsung ,
Smartphones ,
Standard Essential Patents