Eversheds Sutherland (International) LLP

Munich

Munich is a major economic centre in Germany and home to the largest number of listed companies and private equity houses in the country. Tracing back its roots to 1974, the Munich office regularly represents and advises leading domestic international businesses, from DAX 30 corporations to mid-market and emerging enterprises.

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Updates

Healthcare & Life Sciences

European Union recommends measures to be taken for use of technology and data to combat COVID-19
European Union | 23 December 2020

In April 2020 the European Commission issued Recommendation 2020/518 on establishing a common EU toolbox for the use of technology and data to combat the COVID-19 crisis, particularly with regard to mobile apps and the use of anonymised mobility data. The recommendation sets out a process to develop a common approach – a so-called 'toolbox' – in the European Union using the most innovative digital means to address the health crisis.

European Union issues communication on COVID-19 vaccination strategy
European Union | 09 December 2020

According to the European Commission, the swift development and global deployment of safe and effective vaccines against COVID-19 is key to resolving the current public health crisis. In this context, the European Commission is working to ensure Europe-wide access to safe vaccines and encouraging a coordinated vaccination strategy. Thus, in June 2020 the European Union published a communication on the EU Strategy for COVID-19 vaccines, which sets out a number of strategic objectives.

Short-term health preparedness for COVID-19 outbreaks
European Union | 25 November 2020

The European Union recently published a communication on the European Union's short-term health preparedness for COVID-19 outbreaks, which aims to reinforce the European Union's preparedness and create a coordinated response capacity to counter further outbreaks of COVID-19. This article highlights the main measures provided by the communication, including with regard to testing, contact tracing and medical countermeasures.

Latest EU measures relating to COVID-19 pandemic – multicentre clinical trials
European Union | 11 November 2020

Since COVID-19 began to spread, the majority of the world's leading pharmaceutical laboratories have begun clinical trials to find both the right vaccine and the right drug to stop it from spreading. Against this background, EU Regulation 2020/1043 aims to grant a temporary derogation from the requirements concerning a prior environmental risk assessment for the duration of the COVID-19 pandemic or as long as there is a public health emergency.

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.

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.

Tech, Data, Telecoms & Media

EDPB guidelines on personal data breaches: what controllers need to know
European Union | 07 May 2021

The European Data Protection Board (EDPB) recently published the Guidelines on Examples Regarding Data Breach Notification. These guidelines will help data controllers to decide how to handle personal data breaches and what factors to consider during risk assessments. The EDPB guidelines constitute practice-oriented, case-based guidance that is based on the experience gained by data protection authorities in recent years.

European Union recommends measures to be taken for use of technology and data to combat COVID-19
European Union | 18 December 2020

In April 2020 the European Commission issued Recommendation 2020/518 on establishing a common EU toolbox for the use of technology and data to combat the COVID-19 crisis, particularly with regard to mobile apps and the use of anonymised mobility data. The recommendation sets out a process to develop a common approach – a so-called 'toolbox' – in the European Union using the most innovative digital means to address the health crisis.

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.

How to protect against COVID-19 phishing attacks
European Union | 24 April 2020

​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.

Data protection across all borders? GDPR's territorial scope
European Union | 10 January 2020

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.