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 […]

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 […]

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]

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 […]

With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]

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.

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

The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter.

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.

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

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.

Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week.

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

Film critic Justin Chang hosted a live discussion of 'The Avengers,' the first film Times readers chose in the Ultimate Summer Movie Showdown series.

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.

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.

Norwegian Cruise Line says it's in danger of going out of business. Maybe that's not the worst thing for an industry of floating petri dishes.

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.

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

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.

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

The Ramirezes never thought the coronavirus would get them. They took every precaution, but the virus still found its way into their home. Over the course of days, each member of the 10-person household became infected. Three were hospitalized. And one, the family patriarch, died.

Even as Mayor Eric Garcetti has extended testing to everyone in L.A. County, doing the same for homeless people has proved to be far more challenging.

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

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?

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.

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.

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.

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.

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.

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

California reopening: On Abbot Kinney Boulevard in Venice, the normally bustling shopping district that has been largely vacant amid the coronavirus, there were signs of life Friday as some retailers opened for curbside service.

It is an "eerie" day in Seal Beach as businesses struggle to come back and crowds stay away.

Major League Baseball will hold a five-round draft in June, a big reduction from the usual 40 rounds. Many Southland players are expected to be taken.

U.S. leadership, or the lack thereof, in the time of coronavirus

Adam Silver told NBA players that a return to the court is up in the air but that games could be held in Las Vegas or Orlando, likely without fans.

Roy Horn, the dark-haired half of Siegfried & Roy, raised the white tigers and other animals in the duo's extravagant shows that were one of the biggest draws on the Las Vegas Strip.

New data analyzed by the Los Angeles Times show that nearly half of all COVID-19 deaths in the state are associated with elder care facilities.

The coronavirus-idled events team from a ski resort runs a food bank in Basalt, Colo., pivoting from delivering entertainment to helping the hungry.

Despite President Trump's statements that the coronavirus was released from a laboratory in Wuhan, scientist say the evidence points to a natural origin.

Older Americans deserve our protection from coronavirus. They want to get back to their busy lives, too

By Karla L. Palmer —

By Karla L. Palmer —

By Sara W. Koblitz —

The most important thing to know is that the FDA has not approved any at-home diagnostic tests and only one at-home collection kit for the coronavirus.