We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more
The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in support of Regulation (EU) 2017/745 (the "Medical Devices Regulation" -...more
The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices Regulation can be provided in...more
The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This initiative is part of the EU Pharmaceutical Strategy for Europe and calls on...more
The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. In its document, the European Commission identifies the problems currently...more
On 17 November 2020, the European Commission published an inception impact assessment for a revision of the Tissue Directive and the Blood Directive. With this proposal, the European Commission aims to tackle existing...more
On 6 October 2020, the European Commission published guidance on the vigilance system for insulin infusion pumps and integrated meter systems. The guidance provides an illustrative table with examples of what must be reported...more
On 15 April 2020 the European Commission issued guidelines regarding COVID-19 in vitro diagnostic tests. The guidelines offer an overview of the different types of test and their purposes as well as the relevant EU regulatory...more
The European Commission has submitted a proposal to the European Parliament and to the Council for a Regulation amending Regulation (EU) 745/2017 on medical devices. The purpose of the amendment is to defer application of the...more
The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices. The Guidelines concern the benefit-risk...more
On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more
The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in...more
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
2/14/2019
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UK Brexit
On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more
On 9 August 2018, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical...more
The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”) has...more
The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The roadmap has been prepared...more
In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a...more