Qserve COVID-19 Updates and News

COVID-19

COVID-19 updates and news

As the impact of the coronavirus (COVID-19) pandemic on the industry continues to unfold, we understand that the impact COVID is having on the people and companies serving the industry. We are in a rapidly evolving environment and therefore we would endeavour to keep you abreast of news, recommendations, and changes from Europe, China and the US FDA.

 

As global Medtech professionals, supporting companies who are taking care of our Healthcare in a world that is facing an unprecedented situation and the health and safety of people worldwide is a priority.

We have experience with the Humanitarian Exemption routes in China, US, and EU, as well as in other countries around the world. We are happy to share this info and help you to find market access. Please contact our colleague Danielle Motta if you have specific questions regarding the humanitarian exemption route and process.

 

Importing face masks into the European Union?

Due to the Covid-19 crisis the demand for face masks is increasing, especially now governments lift lockdowns and start advising their citizens to wear face masks in public, to help prevent the spread of the virus. These face masks are among the so-called ‘harmonized products’ for which there is a specific EU product legislation in place. 



Learn more

Market access for Covid-19 Self- testing kits

Lockdowns are step-by-step lifted. Governments are increasing the number of tests. At the same time, the market for self-tests is growing quickly; consumers want to know if they have it or not. And they want to check this regularly. 
Getting involved with self-testing kits is complex. It may not be your everyday product compliance process. It involves paperwork, time, money, patience. There are no quick routes to the market.


Learn more

 

COVID-19

Latest news and events

July 06, 2020

EU commission survey on COVID-19 Notified Body services – a surprising story

The European Commission came through with their promise to provide more information on COVID-19 related product assessment by Notified Bodies. They conducted a survey under notified bodies in charge of the certification of COVID-19-related medical devices and IVDs and published a report on their findings.
July 01, 2020

Latest Industry Update | Sue Spencer & Keith Morel

June 30, 2020

EU's MDR Extended: Where Do Medical Device Manufacturers Stand?

The announcement of the one-year delay to the European Union’s Medical Device Regulation (MDR) date of application (new date: May 26, 2021) is shaping up to be a major sense of relief for medical device manufacturers around the world. While we all deal with the enormous impacts of the COVID-19 pandemic, manufacturers are shifting gears with the imminent decision to delay MDR until 2021.
June 30, 2020

Market status by Sue Spencer and Gert Bos

Strange times, with many working remotely, whilst finding a new work-life balance. With several months behind us, we’re getting a little bit used to the new situation. And so do EU’s authorities.
June 18, 2020

Updates to FDA’s COVID-19 Test EUA Templates for Asymptomatic Screening, Pooled Samples & Home Collection

Continuing our series covering market access requirements for COVID-19 tests, the FDA remains diligent in communicating their performance expectations for COVID-19 tests marketed by laboratories and manufacturers in the U.S.w.
May 26, 2020

2 Years TODAY until the IVDR is mandatory

TICK TOCK! Two years and counting! 26 May 2022, the world will be a very different regulatory landscape for IVD industry, there are now just 2 years before the IVDR is mandatory for any IVD that does not have a Notified Body approval today.
May 25, 2020

How PMCF surveys can help collect clinical evidence remotely during the COVID-19 pandemic

Due to the COVID-19 pandemic many clinical investigations other than those aimed at management of the disease have been postponed or suspended. 
May 20, 2020

Update of COVID-19 tests including WHO, EU, Switzerland and UK

There are many good sources of useful and reliable information emerging to support the development of tests during the pandemic.  This blog summarises some of these documents and whilst they may not be relevant for the particular country to which you intend to market your device they still contain useful information about current best practice or expectations.
May 12, 2020

Updates to FDA's EUA Molecular Diagnostic Templates and EUA Policy Plus a New Antigen Template for COVID-19 Tests

On May 11, 2020 FDA again updated their EUA policy to remove the serology templates from the appendices and add a new section VI to point to all EUA templates on their website. 
May 04, 2020

Updates to FDA's EUA Policy and Pathways for COVID-19 Serology Tests

In our last update, we discussed the four pathways for making available SARS-CoV-2 tests through FDA’s EUA process. In the time since, FDA introduced a fifth pathway during its April 29, 2020 virtual town hall specific for certain serology tests and on May 4, 2020 FDA updated their Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
April 28, 2020

Overview: all free webinars in a row

Each day our experts share information in our Knowledge Center. Last month Qserve hosted free webinars all with different subjects. Missed one of our webinars or do you want to watch it again? The webinars are now available on our website!

April 21, 2020

The Corona App - first example of MDR Class I Software?

In the discussion on the Corona App, most of the attention is headed towards Privacy protection, while no one seems to realize that such an App might also be a Medical Device, as its intended purpose is prevention of a disease.
April 21, 2020

BLOG UPDATE - Expectations for the Validation of COVID-19 Tests 

In our last blog we said that this was a rapidly evolving environment and that we would endeavour to keep you abreast of changes. This is our first update with additional information from both Europe and US FDA.
April 20, 2020

Communication push: the most impactful effect COVID-19 has on consulting

Since early March we have been able to support the crisis management teams in three countries to have some better insight into product specifications, comparing foreign standards to their own, generating overviews of products approved in other jurisdictions such as China, and indicating reliable sources we’ve encountered earlier in the global supply chain.
April 17, 2020

Expectations for the Validation of COVID-19 Tests

COVID-19 has created an unprecedented situation around the world. Manufacturers have had to respond at lightening speed to develop tests to a disease that was first identified in December 2019. Testing is an important part of most countries’ strategies to get back to normal.
April 03, 2020

More rapid guidance than we have ever seen emerge – the other side of COVID-19

As authorities are putting huge efforts on getting their grounds covered, literally with new hospitals, new equipment, trained IC staff and more, guidance and rules on what they expect, and how their special market access rules work, are sprouting rapidly.
A quick scan sees that we are approaching 100 documents, the vast majority of which take the form of guidance; second category are notices and rules; and actually one form (UK). 

March 19, 2020

China Regulation Updates from the month of March

In this China Regulation Update, six of the most recent regulation updates for the Chinese market are explained by Stephanie Huang.
January 31, 2020

The battle against 2019-nCoV

Today, 1 month after Chinese authorities alerted the WHO to an outbreak of pneumonia of unknown aetiology in Wuhan City, Hubei Province, the reported affected patient number is reaching 10.000 confirmed and over 12.000 suspected cases throughout the country.
How can we help you? Contact us