12 Jul 2022 European Commission adopts additional rules for the application of In Vitro Diagnostic Regulation By Mariana Ricardo The European Commission recently adopted two new regulations laying down rules for the application of Regulation (EU) 2017/746, as...
08 Jun 2022 Spain’s Medical Device Market to recover in 2022 By Elisa Lorenzo Fitch Solutions Country Risk & Industry Research has published a report confirming that the Spain’s medical devices market will see...
25 Apr 2022 Poland: new medical devices law By Amelia Prawda Jolanta Dabrowicz On 7 April 2022, the Parliament passed the Act of 7 April 2022 on Medical Devices (the "Act"). It was signed by the President on 20...
04 Mar 2022 The beginning of the end: FDA details roadmap to terminating COVID-19 EUAs and enforcement policies for medical devices, PPE By Melissa Gilmore In late February, 2022 the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical...
13 Dec 2021 Do medical devices have systematic bias? By Kate Burgess Anna Ward An investigation has been launched by the UK’s Department of Health and Social Care (“DHSC”) with the overall aim of improving healthcare...
25 Nov 2021 Advertising of medical devices: Italian Ministry of Health confirms national pre-authorization requirement despite MDR By Carlotta Busani Marco de Morpurgo With Circular 0081386 dated 12 November 2021, the Italian Ministry of Health confirmed that the national pre-authorization requirements...
23 Nov 2021 Is the UK the right home for life sciences startups? By Lyndsey Hudson I saw this recent article highlighting the need for the UK to create a much more supportive and sustainable environment for life sciences...
23 Sep 2021 Single-use medical devices' reprocessing and further use to be permitted in Portugal By Mariana Ricardo Portugal initiated the 2015/1535 notification procedure of the decree-law establishing the rules applicable to the reprocessing and...
21 Sep 2021 Open consultation on the future regulation of medical devices in the United Kingdom By Richard Taylor Elinor Cavil BackgroundThe Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...
10 Sep 2021 Clinical trials conducted pre-application can cause enabling disclosure By Richard Taylor Elinor Cavil In a recent webinar titled “Protecting Medical Devices in Europe – Avoiding Common Pitfalls”, Kieran Killough (Partner at HGF) pointed to...
07 Sep 2021 New European Regulations on Medical Devices By Richard Taylor Elinor Cavil New EU regulations governing medical devices and in-vitro diagnostic devices were introduced in May 2017 - the Medical Devices Regulation...
23 Aug 2021 An overview of recent FDA activity on materials in medical devices By Mary Gately Christopher Campbell In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the...
09 Jul 2021 FDA solicits public comment on adding list of device materials to certain medical device labels By Meagan Self Mary Gately Christopher Campbell Since the 1930s, the Food and Drug Administration has required food manufacturers to list each ingredient in a food product by its common...
06 Jul 2021 Poland: A revolutionary draft amendment to the Reimbursement Act By Amelia Prawda Jolanta Dabrowicz Andrzej Balicki, Ph.D. On 30 June 2021, a draft bill amending the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs for Special Nutritional...
04 May 2021 New medical device regulations in China likely to lead to increased regulatory enforcement By Sammy Fang Ting Xiao Han Liang The Chinese State Council has passed the eagerly anticipated revisions to the PRC’s Regulations for Supervision and Administration of...
28 Mar 2021 On the radar: negotiations on a legislative proposal concerning HTA to start By Mariana Ricardo Following the European Commission's (EC) adoption of a proposal for a Regulation on health technology assessment (HTA) in 2018, and the...