The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
Following the renewal of the state of emergency, Decree 3-A/2021 of14January of the Presidency of the Council of Ministers, determines the closure of various types of establishments. Inthiscontext, the employment support measures were amended by Decree-Law 6-C/2021 of 15 January and Decree-Law 6-E/2021 of15January, which we summarised below. 1 ...
Early last year the Prime Minister dropped the “E-bomb” on British motorists, announcing a ban on cars powered wholly by petrol and diesel from 2030, and on the sale of new hybrid vehicles with the capability to drive a significant distance with zero emissions (such as plug-in or full hybrids) from 2035. Since then, the COVID-19 pandemic has impacted the world in an unprecedented manner ...
In December 2020, the National Institute of Industrial Property (INPI) published on its portal the Examination Guidelines for Inventions Implemented by Computer Program ...
Our latest Brexit Insight: Immigration series of webinars focusses on the impact of Brexit on workers and businesses since 31 December 2020. Our Immigration expert, Rachel Harvey, kicked off the first session by discussing the issues surrounding the new frontier worker permit and eligibility, including what a frontier worker is, what a frontier worker permit provides and what your obligations are as an employer for the next 6 months and beyond ...
Our latest Brexit Insight: Immigration series of webinars focusses on the impact of Brexit on workers and businesses since 31 December 2020. Our Immigration expert, Rachel Harvey, kicked off the first session by discussing the issues surrounding the new frontier worker permit and eligibility, including what a frontier worker is, what a frontier worker permit provides and what your obligations are as an employer for the next 6 months and beyond ...
The “right to be forgotten” (“RTBF”) has been central to the global debate over the balance between individual privacy and freedom of information and of the media in recent years. Such right has been affirmed by the European Court of Justice in a milestone case in 2014, as well as later in the UK, although its application in other countries remains uncertain ...
On January 25, 2021, the German federal Cabinet introduced the draft for the new Cyber Security Act (“IT Security Act 2.0”) into the legislative process ( Draft of a Second Act to Increase the Security of Information Technology Systems, printed matter 19/26106 [draft of a second law to increase the security of information technology systems, document 19/26106] ). The new German Cyber Security Act is intended to replace the old German Cyber Security Act of July 2015 ...
On January 25, the State of California lifted its previously enacted emergency stay-at-home order for all 58 counties. The stay-at-home orders were put in place at the beginning of December and were designed to help ease the burden on ICUs throughout the state, which were becoming increasingly inundated with new COVID-19 patients ...
On Jan. 29, 2021, the Occupational Safety and Health Administration (OSHA) released updated guidance regarding mitigating and preventing the spread of COVID-19 in the workplace. Important highlights are as follows. First, the guidance emphasizes that employers should implement a COVID-19 prevention program for the workplace ...
1. Background to the case The case concerned a young, female employee in a mechanical workshop, who felt she had been sexually harassed by two of the enterprise’s customers. Customer No 1 had on one occasion, while the female employee was sitting on the floor in a forward-leaning position, performing work, put his hands on her lower back, under her top ...
On 30 December 2020, the Government of Vietnam issued Decree No. 152/2020/ND-CP (“Decree 152”) which will take effect on 15 February 2021 and replace Decree No. 11/2016/ND-CP of the Government of Vietnam dated 3 February 2016 (“Decree 11”), Decree No. 75/2014/ND-CP of the Government of Vietnam dated 28 July 2014 (“Decree 75”) and its corresponding amendments and supplemental decrees ...
The introduction of mandatory pre-installation of applications developed by Russian market players, caused by a wave of cases of abuse by global companies of their dominant position in digital markets, is a significant innovation in Russian antitrust and consumer protection law. To reduce the risks of restricting competition and balance the bargaining power of global corporations with small domestic application developers, amendments to the Law dated February 7th 1992 No ...
We would like to inform you that several laws, that will have a significant impact on IT and data protection regulation, were adopted at the end of 2020 (“Amendments”). Further rules for blacklisting Internet resources The first amendment to Russian law is aimed at securing guarantees, for citizens’ rights, to freely search, access and disseminate information ...
When it comes to the general transfer of data to third countries, even, for example, intra-group data transfers, recourse to US providers such as Microsoft (Office 365), Amazon (AWS), Google or Salesforce has been ill-fated since the ECJ ruling of July 16, 2020 (C-311/18 “Schrems II”) ...
Introduction In the recent Industrial Court Award of Azffanizam bin Abd v Prince Court Medical Centre Sdn Bhd [Award No.11 of 2021] dated 4 January 2021, the Industrial Court accepted evidence taken from social media in dismissing a claim of forced resignation ...
Introduction In the recent Industrial Court Award of Harry Wong Wei Chen v Petroliam Nasional Berhad [Award No.11 of 2021] dated 4 January 2021, the Industrial Court upheld the dismissal of an employee (“the Claimant”) on account of several allegations of sexual and workplace harassment. An interesting point in the instant case was the absence of corroborative witnesses in respect of several of the complaints against the Claimant ...
This article forms part of our ‘New How: Perspectives’ report: ‘Can real estate help solve the productivity puzzle?. To access this free report, please click on the download link to the right of this page. If somebody asked me at the start of 2020 whether I could join a meeting by video, my immediate thought would have been: “no, that sounds far too difficult and I don’t think we really have the technology to do that” ...
Notwithstanding the pandemic, February marks LGBT History Month; an annual observance of lesbian, gay, bisexual and transgender history. It is important that the progress we have made to date is not only recognised but celebrated ...
Traditionally, Belgian labour law distinguishes between two forms of telework, namely structural telework, regulated by the Collective Labour Agreement n° 85, and occasional telework, regulated by the Act on Workable and Agile Work. Since the start of the Covid-19 pandemic, a third category has been added, namely 'Covid telework', which was, at a certain point, recommended but has now been made compulsory again by the government ...
A new Royal Decree published on 21 January 2021 in the Belgian Official Gazette has temporarily extended the occupational doctor's role in combatting the Covid-19 virus ...
Imagine you instruct an employee to get tested for the Covid-19 virus infection. The employee refuses the test, claiming that the employer is not authorized to instruct him to take such a test. Moreover, the employee claims he had been vaccinated against Covid-19. What is the legal situation? 1 ...
Labor Court Siegburg 11/11/2020 - 4 Ca 1240/20 Short-time work continues to be omnipresent in many sectors of the economy due to the Covid 19 pandemic. A recent decision by the Labor Court Siegburg once again emphasizes that the ordering and implementation of short-time work requires careful preparation on the part of the company in terms of labor law in order to avoid unpleasant surprises ...
