Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)
- 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 series on Software... ›
COVID-19: State Intervention in Times of Vaccine Shortages
By: Robert Grohmann
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 vaccine doses as the pharmaceutical industry slows... ›Key EU Intellectual Property and Trade Secrets
By: Wolfgang Schönig and Mark L. Whitaker
Session 11 of the GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups was led by Life Sciences Transactions + Licensing partner Wolfgang Schoenig focusing on key EU Intellectual Property. Wolfgang discussed Intellectual Property Rights,... ›Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
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 part 2 of our series of articles , in this... ›Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
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 further light on the expansion of the definition... ›Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
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 trend is likely to continue. As with every health-related product... ›Top 10 Considerations When Drafting and Negotiating SRAs, with U.S. and EU Perspectives
By: Wolfgang Schönig, Matt Karlyn and Robert Grohmann
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 results for general research purposes. Care should be taken to... ›The European Commission’s New Pharmaceutical Strategy for Europe
By: Wolfgang Schönig
Nina Schäfer and Jin Ito contributed to this article. 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 strategy aims to achieve various... ›Health Data Made in France- Is France Moving Towards a Sovereign Cloud Requirement for Health Data?
By: Alex van der Wolk
Since the decision of the European Court of Justice (“ECJ”) in the Schrems II case, transfers of personal data from the EU to the United States have been under scrutiny. The ECJ reviewed the situation where personal data are sent from an EU affiliate to its... ›Germany Adopts Administrative Trademark Cancellation Actions
By: Robert Grohmann
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, took effect. In particular, an administrative procedure for the revocation and the... ›