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[Event] HPE Europe 2023 - September 21st, London, United Kingdom

HPE Europe is back! Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more

Great Britain and European Union Timelines: What Are the Key Dates for Transition?

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more

International News: COVID-19 Global Pandemic - May 2020

The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across...more

“App on Prescription”: New Reimbursement Regime for Digital Health Applications in Germany

Health apps and other digital medical devices are making increasingly important contributions to healthcare. While in the past such medical devices were reimbursed by statutory health insurance funds on a case-by-case basis...more

COVID-19 – Legal Implications for Pharmaceutical and Medical Device Companies in Germany

The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more

The EU Medical Device Regulation: What’s Next?

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

International News Life Sciences - Winter 2018

Data Inspections in China: Increased Supervision and Compliance - Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to...more

The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization

On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more

EC Introduces Major Changes to Medical Device Regulation

The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics. The proposed legislation will significantly broaden the scope of medical device...more

12/19/2012  /  EU , European Commission , Medical Devices
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