Extension of the MDR transitional period and removal of the “sell off” periods

European commission has now official published the Q&A on practical aspects related to the implementation of regulation 2023/607 amending regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. 

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.

The answers to the questions set out in the document have been developed by taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.

Read more about it here: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

 

If you would like to know more or need someone to discuss this further with,
don’t hesitate to contact Annelie Hagström here.

 

Come and Meet Us at the Regulatory Summit on March 30th

We are present at Swedish Medtech’s Regulatory Summit on March 30th. Meet us here if you want to know more about what we do, or if you just want to have a quality and regulatory chat. And take the chance to listen to two of our most experienced consultants, Cecilia Emanuelsson and Cilla Lundevall.

Welcome Linda Lindberg!

We are happy to announce that QAdvis has a new consultant in our team, a warm welcome to Linda Lindberg!

Linda has over 15 years of experience in product development and bringing new products to the market within the medical device, in-vitro diagnostic, biotech and pharmaceutical industries, both from start-ups and large international companies. She holds an MSc in Pharmaceutical Sciences and a PhD in Cell and Molecular Biology.

Linda is based in our Stockholm office, but as a part of QAdvis, we work and interact with clients all over the world.

QAdvis Collaboration with Swedish Medtech Continues in 2023

QAdvis will remain as a Swedish Medtech networking partner in 2023 and together we are offering up-to-date courses and seminars addressing current topics within the medical device quality and regulatory landscape.

You can meet us at Swedish Medtech’s Regulatory Summit on March 30th if you want to know more, or if you just want to have a quality and regulatory chat. And take the chance to listen to two of our most experienced consultants, Cecilia Emanuelsson and Cilla Lundevall.