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34 results for: medical devices
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European Commission adopts additional rules for the application of In Vitro Diagnostic Regulation
By Mariana Ricardo
The European Commission recently adopted two new regulations laying down rules for the application of Regulation (EU) 2017/746, as...
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Spain’s Medical Device Market to recover in 2022
By Elisa Lorenzo
Fitch Solutions Country Risk & Industry Research has published a report confirming that the Spain’s medical devices market will see...
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Poland: new medical devices law
By Amelia Prawda Jolanta Dabrowicz
On 7 April 2022, the Parliament passed the Act of 7 April 2022 on Medical Devices (the "Act"). It was signed by the President on 20...
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The beginning of the end: FDA details roadmap to terminating COVID-19 EUAs and enforcement policies for medical devices, PPE
By Melissa Gilmore
In late February, 2022 the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical...
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Do medical devices have systematic bias?
By Kate Burgess Anna Ward
An investigation has been launched by the UK’s Department of Health and Social Care (“DHSC”) with the overall aim of improving healthcare...
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Advertising of medical devices: Italian Ministry of Health confirms national pre-authorization requirement despite MDR
By Carlotta Busani Marco de Morpurgo
With Circular 0081386 dated 12 November 2021, the Italian Ministry of Health confirmed that the national pre-authorization requirements...
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Is the UK the right home for life sciences startups?
By Lyndsey Hudson
I saw this recent article highlighting the need for the UK to create a much more supportive and sustainable environment for life sciences...
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Single-use medical devices' reprocessing and further use to be permitted in Portugal
By Mariana Ricardo
Portugal initiated the 2015/1535 notification procedure of the decree-law establishing the rules applicable to the reprocessing and...
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Open consultation on the future regulation of medical devices in the United Kingdom
By Richard Taylor Elinor Cavil
BackgroundThe Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...
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Clinical trials conducted pre-application can cause enabling disclosure
By Richard Taylor Elinor Cavil
In a recent webinar titled “Protecting Medical Devices in Europe – Avoiding Common Pitfalls”, Kieran Killough (Partner at HGF) pointed to...
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New European Regulations on Medical Devices
By Richard Taylor Elinor Cavil
New EU regulations governing medical devices and in-vitro diagnostic devices were introduced in May 2017 - the Medical Devices Regulation...
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An overview of recent FDA activity on materials in medical devices
By Mary Gately Christopher Campbell
In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the...
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FDA solicits public comment on adding list of device materials to certain medical device labels
By Meagan Self Mary Gately Christopher Campbell
Since the 1930s, the Food and Drug Administration has required food manufacturers to list each ingredient in a food product by its common...
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Poland: A revolutionary draft amendment to the Reimbursement Act
By Amelia Prawda Jolanta Dabrowicz Andrzej Balicki, Ph.D.
On 30 June 2021, a draft bill amending the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs for Special Nutritional...
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New medical device regulations in China likely to lead to increased regulatory enforcement
By Sammy Fang Ting Xiao Han Liang
The Chinese State Council has passed the eagerly anticipated revisions to the PRC’s Regulations for Supervision and Administration of...
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On the radar: negotiations on a legislative proposal concerning HTA to start
By Mariana Ricardo
Following the European Commission's (EC) adoption of a proposal for a Regulation on health technology assessment (HTA) in 2018, and the...
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