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EU MDR And IVDR Implementation: European Commission Publishes Full Proposal For Amending Transitional Regime

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

EU MDR And IVDR Implementation: Signs Of Relaxing Transitioning Regime And Bridging Measures

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

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

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

EU: IN VITRO Diagnostic Regulation Entered Into Force (Part 1 OF 3)

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

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 6 Of 6)

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

Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap

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

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 Of 6)

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

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...more

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

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

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 2 Of 6)

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

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 1 Of 6)...

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

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