Nov 22, 2023 Global Compliance Guide for Engaging Healthcare Professionals By Jolanta Dabrowicz Andrzej Balicki, Ph.D. Joanna Barker-Wall Pharmaceutical companies rely on the knowledge and expertise of healthcare professionals for purposes such as scientific discussions,...
Oct 06, 2023 Poland - Life Sciences Monthly Brief, September 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our September monthly briefing for Poland, which covers key updates and insights in the following areas: Medicinal...
May 16, 2023 The future of the assisted reproductive technology (ART): Modernising ART processes with AI By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Abi Ketheeswaran +1 more... Show less Assisted fertilisation processes involve striking the perfect balance between a range of complex factors – all of which play a critical...
Apr 11, 2023 Italy modifies medical device payback system for 2015-2018: Companies have to make quick and important choices By Giorgia Romitelli Giovanni Iaselli Roberta Moffa With Law Decree no. 34/2023, the Italian government has approved significant changes to the Italian medical devices payback system for...
Apr 03, 2023 New Guidance from the Medicines & Healthcare products Regulatory Agency (MHRA) on the Intended Purpose Statement for Medical Device Software By Poppy Williams As part of the MHRA’s Software and AI as a Medical Device Change Programme, the MHRA has recently published guidance on crafting an...
Mar 20, 2023 Extended transition period gives medical device industry extra time to comply with EU MDR By Marco de Morpurgo Nicola Landolfi A much-awaited extension of the MDR transition period became effective today with the publication of Regulation (EU) 2023/607 in the...
Mar 10, 2023 Poland - Life Sciences monthly brief, February 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our January monthly briefing, which covers key updates and insights in the following areas: Medicinal productsClinical...
Jan 23, 2023 Pharmaceutical and medical sector in Poland, DLA Piper Report By Andrzej Balicki, Ph.D. Jolanta Dabrowicz We would like to invite you to read our report summarising the second edition of the DLA Piper survey "Pharmaceutical and medical sector...
Sep 30, 2022 Italy reintroduces payback systems for medical devices. How can companies act to avoid excessive spending By Giorgia Romitelli Roberta Moffa With Law Decree no. 115/2022 (Aiuti Bis Decree), the Italian Government reactivated the so-called “payback” system for medical devices....
Sep 20, 2022 Italian adapts national medical device framework to MDR and IVDR By Marco de Morpurgo Carlotta Busani Italy enacted legislation to adapt the national framework governing medical devices and in vitro-diagnostic medical devices to the MDR...
Jul 12, 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...
Jun 08, 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...
Apr 25, 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...
Mar 04, 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...
Dec 13, 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...
Nov 25, 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...