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Medical Devices

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HealthcareMedical DevicesMedTech
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 month, the Medicines & Healthcare products Regulatory Agency ("MHRA") published guidance on "Software and Artificial Intelligence (AI) as a Medical Device". It didn't necessarily provide for any new regulatory approach to AI in the therapeutic space, but it brought together some important material during this period of increasing interest in AI to effectively remind software...
May 22, 2023
3 min read
regulation of medical devices General
Sophie Vo
Sophie Vo
Proposed updates to the regulation of medical devi...
While it might be challenging for manufacturers of medical devices...
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...
Telemedicine has been available to healthcare providers for several...
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...
The rise in the volume of cyber incidents, the war in Ukraine,...
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
Biotech
Chris de Mauny
Chris de Mauny
 Domien Op de Beeck
Domien Op de Beeck
Final(ly) Rules of Procedure of the UPC
Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations,...
July 18, 2022
1 min read
Biotech
Henri Kaikkonen
Henri Kaikkonen
 Mikko Nurmisto
Mikko Nurmisto
To opt-out or not? The UPC will change the rules of the game in the European patent field possibly as soon as next fall
Early this year it became clear that the long-pending reform of the European patent system is finally...
June 1, 2022
7 min read
General
Mauro Turrini
Mauro Turrini
 Nadia Feola
Nadia Feola
Artificial Intelligence Systems for Medical Diagnosis
The Italian Ministry of Health has published a document on its website entitled “Artificial Intelligence...
May 25, 2022
1 min read
Biotech
Wouter Pors
Wouter Pors
The UPC Committees rule!
Start of the Provisional Application Phase and first committee meetings The Provisional...
April 7, 2022
12 min read
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