COVID-19: Weekly Life Sciences Digest – Guidance for Industry in EU, UK and US
Natasha Leskovsek, Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
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.
RED Talk: EU consulting on proposed laws to deal with software that alters the safety or compliance of connected devices
Tracey Bischofberger and Alicia Johnson-Cole
The European Commission is holding a targeted consultation on proposed new laws to deal with software that alters the safety or compliance of connected devices. The consultation closes on 22 May 2020.
Green is for go: European Commission presents its action plan for the single market
Edward Turtle and Carol Holley
The action plan sets out proposals for better implementation and enforcement of single market rules.
Unprecedented and under pressure? How international product regulators are responding to COVID-19
Claire Temple, Rod Freeman, Matt Howsare and Olivia Flasch
In such unprecedented times, international product regulators are finding themselves under increasing pressure and seem to be reacting with a previously unseen level of agility and flexibility. We look at what is happening, globally. Is it business as usual? What are we seeing them focus on? And what does this mean for the future of products regulations?
COVID-19 – Cooley’s multi-disciplinary response team and resources
Our dedicated multi-disciplinary team are on hand to get you through the COVID-19 crisis
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.