The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

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.

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.

The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.

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

The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now.

As the economy has cratered, mortgage lenders tightened standards for people who are still interested in buying or refinancing a home.

Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat.

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

Kings County Supervisor Doug Verboon said the outbreak at Central Valley Meat Company in Hanford accounts for nearly two-thirds of the coronavirus cases in the rural county, which has a total of 211 reported cases.

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.

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.

California Gov. Gavin Newsom says he doesn't see full stadiums of fans for sports happening amid the coronavirus outbreak until a vaccine is available.

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

The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope.

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.

The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America.

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

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.

Coronavirus pandemic widens racial and political divisions

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

Loyola swimming star Riley Griffis quickly read the reality of life outside the pool: 'The time away has shown it's something I need to function."

It was one of last year's hot tickets: Gustavo Dudamel, Esa-Pekka Salonen and Zubin Mehta, on the same stage at the same time. How to see it for free.

California college students will get emergency CARES grants

If you factor in a potential undercount of furloughed workers, nearly 1 in 5 working Americans may be in line for unemployment benefits.

Many countries saw the coronavirus as a "rich man's disease" imported by overseas travelers. It has since hit marginalized groups the hardest.

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.

City and county trails reopen this weekend. Almost every day, the rules change in the beaches and parks of Southern California. Here's the latest.

The America that condones mass murder of children is allowing the coronavirus to spread.

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.

From cash and snacks to a verbal 'thank you,' there are options when it comes to showing your appreciation for delivery drivers.

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

COVID-19 victims in their 20s and 30s make headlines, but does it mean the coronavirus has become more dangerous to younger people? Here's what we know.

The NHL announces it is postponing the Global Series games that were scheduled to be held in the Czech Republic and Finland in the 2020-21 season.

In the past week, Orange County has announced 21 deaths linked to COVID-19, pushing the total since the pandemic began to 71.

Merchants rejoice they finally reopen businesses and greet customers, with social distancing