This is not a drill. Companies and law enforcement agencies around the world have been left scrambling after the world’s most prolific ransomware attack hit over 500,000 computers in 150 countries over a span of only 4 days. The ransomware – called WannaCry, WCry, WannaCrypt, or WannaDecryptor – infects vulnerable computers and encrypts all of...… Continue Reading

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude.

Here is where masks are currently required, as well as proposals that would dramatically increase face-covering requirements.

In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts.

Bill Oakley, a writer on "The Simpsons," admitted on Twitter that perhaps the animated TV show did forecast some of our troubling current events.

Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday.

Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday.

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.

For goodness sake, if you're going to hike, wear a mask.

California DMV will reopen 25 field offices after shutdown

Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66.

Until millions of Americans can be tested weekly for coronavirus, states will walk blindly into restarts. But NIH director has a plan to ramp up.

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.

San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike.

A federal judge found that the uncertainty surrounding the COVID-19 pandemic was good cause for the delay.

Newsom cited the case when asked why personal services, such as nail salons, must remain closed.

Souplantation's owner says there was no way the restaurants' longtime self-serve model could survive in the era of COVID-19

Analysts say steep jump in unemployment and layoffs caused by the pandemic will be hard to reverse quickly.

Nursing facilities account for a large percentage of COVID-19 deaths. Better protection and testing can change that.

Republicans, once confident of keeping their Senate majority in the fall election, now fear Democrats have a fresh advantage as the coronavirus crisis has reshaped campaigns.

It was impossible to maintain any kind of social distance and there was no way to protect oneself from COVID-19.

Trump admits that he's putting Americans at grave risk by encouraging economices to reopen. He should protect us with testing.

As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe.

Reopening California begins -- but very slowly, cautiously and under the shadow of a second wave.

When it opened last week for the first time since mid-March, Nomads Canteen in San Clemente quickly filled with customers eager to get out of the house and return to some sense of normalcy amid the COVID-19 pandemic.

With no coronavirus vaccine in sight, employers and building landlords are turning to tech, design and distancing to keep office workers healthy.

Doctors have recently identified a condition called pediatric inflammatory multi-system syndrome among children who have tested positive for antibodies against COVID-19.

The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for.

LAX and many airlines are now requiring face coverings to avoid coronavirus spread. TSA agents will don them too.

California college students will get emergency CARES grants

Parts of California, including Los Angeles County, are allowing some businesses to offer curbside service Friday.

California is slowly reopening, providing hope that you might soon see your favorite artist in concert. But from an arena stage? A computer screen? A drive-in?

Carson Meyer, daughter of an NBCUniversal executive and sister of jewelry designer Jennifer Meyer, is reaching parents-to-be virtually in the COVID-19 age.

California reopening: Traffic volume is steadily creeping up, and travel times are getting longer.

The vast majority of California isn't close to meeting Gov. Gavin Newsom's reopening requirements, a Times analysis finds.

Amid a plateau in the number of new coronavirus-related deaths in Los Angeles County, officials Friday were easing into an economic recovery plan.

A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods.

Orange County continues to confirm more coronavirus cases. Here's the latest community breakdown.

Robert De Niro told Stephen Colbert he wants to play New York Gov. Andrew Cuomo in a pandemic movie. And Cuomo approves.

Three more inmates died of coronavirus and the number who are infected has more than doubled at the California state prison in Chino, officials said.

Tesla must follow the same rules that apply to other nonessential businesses, Alameda County officials said.

The U.S. death toll in the coronavirus outbreak surpasses 77,000 as states continue to ease restrictions and President Trump pushes for faster reopening.