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.
According to the European Union Agency for Cybersecurity, there has been a strong increase in so-called 'phishing attacks'. Cyber criminals are taking advantage of the widespread uncertainty regarding COVID-19 and are trying to gain access to confidential information. If companies or employees have been the victim of a successful phishing attack, they must immediately take protective measures to restore data security.
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.
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.
The European Data Protection Board (EDPB) recently adopted its final guidelines on the territorial scope of the EU General Data Protection Regulation (GDPR). In principle, the EDPB's guidelines are not binding for companies. Nevertheless, they play an important role in the interpretation of the GDPR by the courts and data protection authorities.
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.
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.
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.