Are you a non-EU medical device manufacturer? If so, Lumis could be your gateway into Europe via our new authorised representative service.

In accordance with Article 11 (1) of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), any manufacturer not established within an EU Member State must designate an Authorized Representative to market their devices within the EU.

This webinar is divided into several sections, either focusing on different aspects of orphan designation (OD) in key global markets or rare disease trials. The goal is to provide attendees with a comprehensive understanding of the benefits, application processes, and strategic implications of securing orphan designations globally.

This is a comprehensive review of the process, pitfalls, and procedures to get study approval for medical device clinical trials. We look into the future and unpack the present, in terms of European medical device regulation and the local regulatory landscape. Along with the intricacies of EU MDR 2017/745 medical device regulations, we provide an important summary of medical device study classifications and the corresponding submission pathways. 

Transitioning studies approved under the Clinical Trials Directive 2001/20/EC (CTD) to the new Clinical Trials Regulation 536/2014 (CTR) is a common challenge for sponsors. This blog will provide an overview of how to transition a study to the CTR and some key considerations.

Recently, it was the 10-year anniversary of the founding of Lumis International. Here the founders reflect on the lessons learned during that time.

We sat down with Heike Schön our Managing Director to discuss how our clients can remain inspection ready this year, Clinical Trials Information System (CTIS) and to find out what Lumis have in store for 2023!