News from QAdvis | QAdvis AB

IDL Biotech has chosen QAdvis for regulatory guidance and support

QAdvis has signed an agreement with IDL Biotech. We are proud to be a part of this exciting collaboration in which we will plan and conduct clinical studies for the IVD test UBC® Rapid.

Based on the results, QAdvis will provide further regulatory guidance and support to IDL with the FDA application. As part of the collaboration, QAdvis U.S. partner New World Regulatory Solutions, Inc. is also engaged in the project.

UBC® Rapid is intended for the detection of bladder cancer in particular in high-risk patients and to monitor the development of the disease after an established diagnosis.

Update on situation with Covid-19

The ongoing situation with Covid-19, with the extended time range on recommendations to work from home from Sweden’s Public Health Agency also maintains our limitations regarding visitors in our office premises.

In order to eliminate any risk of QAdvis hosted events or QAdvis employees becoming a source of risk for clients and colleagues, we have decided to extend the time range on offering our courses and breakfast seminars remotely until December.

The health and well-being of our colleagues, clients, friends and families are our first priority.

QAdvis has been able to the outmost extent support our clients and deliver according to plans. We strive to offer all our services with unchanged capacity and quality. The situation has led to an increase of solutions where more remotely work and communication made it possible to offer our services without interruption.

Our offices in Lund and Kista are open but with very limited on-site personnel and we hope the situation will normalize as soon as possible.

All of us can of course be reached by phone, e-mail, website as always.

Information will be updated continuously on our website. Don’t hesitate to contact us on info@qadvis.com

Stay safe and healthy.

EU Parliament voted positively to the proposal of postponing the Medical Device Regulation for one year

On (17 April 2020), the EU Parliament communicated the outcome of positive voting session to adopt the Commission’s proposal to postpone the Medical Device Regulation by one year due to the Corona situation. New Date of Application will be 26 May 2021. The change will enter into force as soon as it is published in the Official Journal of the EU.

EU Parliament press release on the decision

EU Commission press release on the proposal

Updated news:

On Friday, April 24, 2020 the amendment postponing the Date of Application (DoA) for MDR with one year have been published in the Official Journal of the EU.

EU Commission working on a proposal to postpone the new Medical Device Regulation for one year

Today (25 March 2020), the Commission announced that they are working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May.

This decision will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.

See video here