Month: April 2020

The right to be recognised, rebooted: Regulation (EU) 2019/515 on the mutual recognition of goods starts to apply

Claire Temple, Edward Turtle and Olivia Flasch

The EU’s new regulation on the mutual recognition of goods has started to apply. One part of the so-called “Goods Package”, it aims to improve the application of the mutual recognition principle for goods and remove unjustified barriers to trade within the EU.

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.

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

Rod Freeman and Fergal Duggan

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.