The right to be recognised, rebooted: Regulation (EU) 2019/515 on the mutual recognition of goods starts to apply
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.
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 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
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.
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?
The ever-changing COVID-19 regulatory landscape: The European Commission issues guidance on the manufacture of certain medical supply products for COVID-19
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.
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.