Category: Regulation & compliance
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.
2020 ICPHSO Annual Meeting and Training Symposium: key highlights
Jamie Humphreys and Carol Holley
Product safety professionals from around the globe attended the ICPHSO Anunal Symposium in Orlando. We are pleased to bring you some of the highlights coming out of the many interesting sessions.
WEBCAST: Extraordinary Times Call for Extraordinary Measures – The Response of Product Regulators Around the World to the COVID-19 Crisis
Cooley’s international products law team is pleased to announce the launch of a webcast series focused on the issues product manufacturers and suppliers are facing in the rapidly changing global environment. This series will deliver practical insights and the latest updates on critical matters for companies in the products sectors. […]
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.
The Circle of (Product) Life – EU Commission adopts new Circular Economy Action Plan
Tracey Bischofberger and Olivia Flasch
The European Commission adopted a new Circular Economy Action Plan that will have wide-ranging implications on how products are designed, marketed and used in the EU.
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
Sarah-Jane Dobson
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 Regulator: European Commission sets out approach on the future regulation of AI
Jamie Humphreys and Tracey Bischofberger
The European Commission released its proposals on a future regulatory framework for AI, favouring mandatory risk-based requirements for high-risk applications, along with targeted amendments to existing EU safety and liability legislation.