MoFo Life Sciences

March 11, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
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
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February 26, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
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
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February 24, 2021 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
Life Sciences Regulatory Framework Becomes Law Post-Brexit
By: Jenny Galloway
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021 (the Act). The purpose of the Act is
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February 19, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
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
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February 12, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
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
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November 13, 2020 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
UK Plans for Robust Life Sciences Regulation Post-Brexit
By: Wolfgang Schönig
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for
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May 26, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps
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May 08, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action
COVID-19 Alert: FDA updates antibody test policy
By: Erin M. Bosman and Julie Y. Park
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been
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April 28, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Healthcare
Mental Health during COVID-19: FDA Waivers for Digital Health Devices
By: Jean Nguyen Ph.D.
As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern. Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating
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April 22, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
FDA Uses EUAs Broadly In The Fight Against Covid-19
By: Julie Y. Park
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel
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Topic Archives: Medical Devices + Diagnostics

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

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

Life Sciences Regulatory Framework Becomes Law Post-Brexit

By: Jenny Galloway

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

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

UK Plans for Robust Life Sciences Regulation Post-Brexit

By: Wolfgang Schönig

FDA Signals Flexibility with COVID-19 Tests

By: Erin M. Bosman and Julie Y. Park

COVID-19 Alert: FDA updates antibody test policy

By: Erin M. Bosman and Julie Y. Park

Mental Health during COVID-19: FDA Waivers for Digital Health Devices

By: Jean Nguyen Ph.D.

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Julie Y. Park