UK-specific guidance for the application and management of clinical trials in the context of COVID-19
Sarah-Jane Dobson and Amal Ali
The UK’s MHRA has stated it will be particularly flexible and pragmatic in authorising clinical trials connected to COVID-19, referring to its previous track record of having acted swiftly in past public health crises
WEBCAST: Products & Consumer Rights: Global Hot Topics
Cooley’s international products law team is pleased to announce the third event in its webcast series looking at the latest consumer rights issues product manufacturers, suppliers and other stakeholders are facing in the rapidly changing global environment. This time we will be joined by Wendy Hederman, a partner at leading Irish law […]
2020 Vision – Looking Beyond COVID-19: Longer-Term Considerations for Supply and Manufacture of Products During COVID-19
Sarah-Jane Dobson, Andrew Barr and Richard Hopley
With COVID-19 causing a pivot or volume increase in production, companies should pause to reflect on the longer-term considerations in terms of international product safety, liability and insurance law issues.
WEBCAST: 2020 Vision – Looking Beyond COVID-19. Longer-Term Considerations for Supply and Manufacture of Products During COVID-19
Many companies are opting to rapidly pivot into new product lines or significantly increase their production volumes. In doing this, they are relying on exceptions to, and derogations from, the usual regulatory regimes, or a flexible approach to enforcement by regulatory authorities – all motivated by the unique context of COVID-19. […]
The EU delays application of its new medical devices regime
Sarah-Jane Dobson and Ross Lennox
The EU has decided to postpone application of its new medical regime by one year. Although COVID-19 is cited as the reason, the delay is no doubt welcomed by an industry that has lobbied for postponement of the regime for some time because of perceived issues with its implementation.
The ever-changing COVID-19 regulatory landscape: The European Commission issues guidance on the manufacture of certain medical supply products for COVID-19
Sarah-Jane Dobson and Olivia Flasch
The regulatory environment for rapid production of COVID-19 medical supplies changes on a daily basis. Most recently, the European Commission has weighed in to provide some Europe-wide insight. The guidance provided only serves to underline the significant pressures that all of those in these areas are having to grapple with, as well as the considerable complexity of applicable regulatory regimes.
UK-specific guidance for manufacture and supply of certain medical devices for COVID-19
As noted in our previous overview article, it is vital that interested companies continue to monitor and strategically act on the rapidly changing government position on the regulation of specific medical supply product types in the context of COVID-19.
Extraordinary Times, Extraordinary Measures: How to become a medical supply manufacturer in Europe in the times of the COVID-19 pandemic
The extraordinary times we find ourselves in during the global COVID-19 crisis has led to extraordinary measures being taken by product manufacturers and suppliers across the globe. Regulatory bodies and governments around the world are taking equally unprecedented measures.
Adapting to the New World
An update on how the Cooley products team is responding to the changes brought on by COVID-19.
Disruption caused by COVID-19
We all hope that the predictions about the spread and seriousness of COVID-19 (coronavirus) prove to be unfounded. Whatever course the development of the virus takes, many of the measures that have been taken or are under consideration by governments, businesses and other organisations are already having or will have a significant effect on commercial relationships and commercial life generally.