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UK medical devices regime set for an upgrade
Just 7 months after the expiry of the Brexit transition period, the Medicines and Healthcare products Regulatory Agency (“MHRA”), the UK regulator overseeing medical devices (amongst other areas), has set in motion a consultative process aimed at updating the current UK legal framework relating to medical devices, which promises to “prioritise patient safety while fostering innovation”.  The Medicines and Medical Devices Act 2021 (available here) empowers the MHRA to amend...
October 7, 2021
4 min read
Impact of Brexit on Artificial Intelligence in Hea...
AI developments in the UK The UK is starting...
February 5, 2021
5 min read
French Healthtech in the Covid crisis: when strategic...
The strategic challenges of the French Healthtech sector - health,...
October 13, 2020
6 min read
Hungary: New Legal Provisions set out Mandatory Infrastructure...
Until recently the Hungarian legal background of telemedicine...
September 29, 2020
4 min read
Post-Transition Brexit: New MHRA Guidelines on Medical Devices
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 21, 2020
4 min read
COVID-19: Our series of regulatory legislation trackers for the Life Sciences & Healthcare industry
COVID-19 presents an unprecedented challenge to the global life sciences industry.  Members...
July 30, 2020
1 min read
Increased Leeway for Cooperation between Pharma and Medical Equipment Companies during the Covid-19 Crisis
Competition rules are aimed at safeguarding healthy competition between companies. For more than half...
April 9, 2020
7 min read
German Constitutional Court declares the vote on the ratification act of the UPC Agreement unconstitutional because of a lack of the required quorum
Today the German Constitutional Court (Bundesverfassungsgericht) ruled that the German ratification...
March 20, 2020
5 min read
TGA Proposes New Course of Treatment for Software as a Medical Device
In December 2019 the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019...
March 10, 2020
8 min read
Digital Technologies in Healthcare: The Liability Challenges
Digital technologies are increasingly transforming the way in which products are being made and services...
February 27, 2020
12 min read
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