Healthcare & Life Sciences, Eversheds Sutherland (International) LLP updates

European Union

Contributed by Eversheds Sutherland (International) LLP
Conducting clinical trials during COVID-19 crisis: FAQs
  • European Union
  • 20 May 2020

COVID-19 is having a significant impact on clinical trials due to its affects on EU healthcare systems, including limited or no patient contact, restricted access to trial sites and investigational medicinal product shortages. The pandemic is not only compromising effective patient treatment, it will also significantly affect ongoing and planned clinical trials, which are crucial for developing medicines and vaccines. Sponsors and investigators must therefore adapt their management of clinical trials.

SPC regulation amendment and export manufacturing waiver: in-depth analysis
  • European Union
  • 23 October 2019

A supplementary protection certificate (SPC) is an EEA-wide IP right that extends the duration of certain rights associated with a patent (particularly human or veterinary medicinal and plant protection products) and which enters into force after expiry of a patent on which it is based. This article presents an in-depth analysis of the medicinal product SPC landscape, particularly in regard to SPC regulation amendments and the export manufacturing waiver.

One year to go: Q&A on EU Medical Devices Regulation
  • European Union
  • 07 August 2019

The EU Medical Devices Regulation (MDR) entered into force in May 2017 and will fully apply from 26 May 2020. While the existing medical device regime requirements will remain, the MDR imposes additional requirements and stricter standards on medical device manufacturers and broadens the scope of product coverage. This article answers important questions relating to the new regulation.

EU Medical Devices Regulation to apply from May 2020 – preparations underway
  • European Union
  • 17 July 2019

The existing EU legislation regulating medical devices will be replaced by the Medical Devices Regulation. The new regulation changes the European legal framework for medical devices, broadens the scope of the products and operators covered under this legislation and provides for increased responsibilities and obligations for manufacturers and notified bodies. It entered into force in May 2017 and will fully apply from 26 May 2020.

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