Ms Magdalena Kotyrba

Magdalena Kotyrba

Updates

Healthcare & Life Sciences

Cybersecurity in healthcare sector – Q&A on data breaches in relation to medical devices
European Union | 19 August 2020

The use of connected medical devices has changed the way in which the healthcare sector works. However, the various benefits based on the advance of connected healthcare come with an increased flow of personal data, whether in hospitals or between different market players in the healthcare industry, which has led to an increased risk of cybersecurity incidents and personal data breaches.

Intellectual property in clinical trials
European Union | 12 August 2020

Clinical trial results may qualify for protection as IP rights and, as such, for commercialisation in the European Union. In order for clinical trial results to be commercialised, they must be protected by the parties involved (eg, sponsors, institutions, investigators or contract research organisations). Clinical trial results may also be protected in the European Union using supplementary protection certificates, regulatory data exclusivity, orphan market exclusivity or paediatric-use marketing authorisation.

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.

EU postpones MDR due to COVID-19: losses and opportunities for medical device sector
European Union | 22 April 2020

In light of the COVID-19 pandemic's impact on medical device industry players (eg, manufacturers, notified bodies, suppliers, production sites and research institutions), on 25 March 2020 the European Commission announced that it intends to postpone the application date for the EU Medical Device Regulation (MDR) from May 2020 to May 2021. The European Council agreed to the MDR postponement on 7 April 2020 and the European Parliament followed suit on 17 April 2020.

COVID-19: impact on medical device industry in European Union
European Union | 15 April 2020

The COVID-19 pandemic is having a significant impact on the medical device industry in the European Union. For instance, scientists and engineers who have been working on the new EU Medical Device Regulation framework for several years are now switching to COVID-19-related research. The pandemic has also significantly increased the demand for protective equipment such as face shields, protective mouth and nose masks, protective clothing and gloves.

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.

Intellectual Property

Intellectual property in clinical trials
European Union | 17 August 2020

Clinical trial results may qualify for protection as IP rights and, as such, for commercialisation in the European Union. In order for clinical trial results to be commercialised, they must be protected by the parties involved (eg, sponsors, institutions, investigators or contract research organisations). Clinical trial results may also be protected in the European Union using supplementary protection certificates, regulatory data exclusivity, orphan market exclusivity or paediatric-use marketing authorisation.

Tech, Data, Telecoms & Media

Cybersecurity in healthcare sector – Q&A on data breaches in relation to medical devices
European Union | 14 August 2020

The use of connected medical devices has changed the way in which the healthcare sector works. However, the various benefits based on the advance of connected healthcare come with an increased flow of personal data, whether in hospitals or between different market players in the healthcare industry, which has led to an increased risk of cybersecurity incidents and personal data breaches.