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.
No chance of makeup – Brexit update for cosmetics companies in the EU and UK
Due to some unique aspects of the EU Cosmetics Regulation compared to other EU product safety regulations, the cosmetics industry has been particularly impacted by Brexit. Given that Brexit has now taken place, it is timely to reconsider this ongoing impact on industry and provide some guidance on forward-looking planning.
The MHRA make it clear: the UK will take a backseat in EU’s medicine licensing regime post-Brexit
On 18 February 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), updated its guidance on medicine licensing post-Brexit “Apply for a licence to market a medicine in the UK”. The update provides further clarity on the UK’s status in the licensing process now that Brexit has taken place.
8 for 8: UK Government accepts key recommendations to reform recall and product safety regimes
In January 2018, the UK’s Department for Business, Energy and Industrial Strategy (“BEIS”) provided its much-awaited response to proposals for reform to the product safety and product recall regimes.