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Medical Devices

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BiotechGeneralHealthcareMedical Devices
Andy van Esdonk
Andy van Esdonk
CJEU AG opinion: pharmaceutical company has EU VAT refund rights following ex lege payments to state health insurance body
On June 6, 2024, the Advocate General (AG) at the Court of Justice of the European Union (CJEU) delivered an opinion in case C-248/23 involving Novo Nordisk AS. The case pertains to the ex lege contributions paid by the pharmaceutical company to Hungary's state health insurance body, which subsidizes the retail sale of medicinal products in the country. The AG concluded that these contributions are effectively price reductions, entitling the pharmaceutical company to VAT refund rights. Why...
June 18, 2024
2 min read
medical companies Healthcare
Hester Borgers
Hester Borgers
 Jephta Zantinge
Jephta Zantinge
Developments in the Netherlands on preventing unwanted...
On 8 April 2024, the Dutch Minister of Medical Care (the
April 30, 2024
6 min read
healthcare General
Alexandre Vuchot
Alexandre Vuchot
 Johanna Harelimana
Johanna Harelimana
 Nour Saab
Nour Saab
Circular economy: what impact for healthcare playe...
Environmental awareness and the desire to limit or eliminate...
September 28, 2023
6 min read
AI and the life sciences Medical Devices
Hester Borgers
Hester Borgers
 Christian Lindenthal
Christian Lindenthal
AI and the life sciences, navigating the complex legal...
Bird & Bird’s international life sciences and healthcare...
August 10, 2023
5 min read
Healthcare
Sophie Vo
Sophie Vo
AI as a Medical Device
To add to all the chatter about AI, let's talk about AI as a medical device. Last...
May 22, 2023
3 min read
General
Sophie Vo
Sophie Vo
Proposed updates to the regulation of medical devices
While it might be challenging for manufacturers of medical devices to navigate the evolving regulations...
May 10, 2023
3 min read
Biotech
Katrina Dang
Katrina Dang
 Johanna Harelimana
Johanna Harelimana
 Christian Lindenthal
Christian Lindenthal
 Hester Borgers
Hester Borgers
 Emma Stok
Emma Stok
 Pieter Erasmus
Pieter Erasmus
 Patrick Brown
Patrick Brown
 Enrique Rivas
Enrique Rivas
An international overview of the regulatory legislation concerning telemedicine
Telemedicine has been available to healthcare providers for several years. However, it was not until quite...
April 24, 2023
1 min read
NIS2 Directive and the CER Directive General
Deirdre Kilroy
Deirdre Kilroy
 Georgina Parkinson
Georgina Parkinson
The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector
The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased...
February 17, 2023
9 min read
General
Pieter Erasmus
Pieter Erasmus
 Hadrien Espiard
Hadrien Espiard
Update on the UK’s future medical device regulations: Extended timelines
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction...
October 31, 2022
2 min read
Medical Devices
Simone Cadeddu
Simone Cadeddu
 Mauro Turrini
Mauro Turrini
 Nadia Feola
Nadia Feola
The Activation of Payback on Medical Devices
The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure...
October 7, 2022
1 min read
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