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
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 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
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
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
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