Lumis blog posts

For medical device manufacturers outside the EU, Authorized Representatives are crucial for navigating the complexities of the MDR and IVDR. Authorised representatives provide essential support for vigilance activities and play a key role in supporting CAPA processes. Authorised representative involvement strengthens compliance and communication, allowing manufacturers to focus more on innovation whilst maintaining the highest level of safety and performance.

A Vigilant Ally – How Authorised Representatives Support Vigilance Activities Read more

Authorised Representatives (EC-REP) can be strategic partners and not just a compliance necessity. A good EC-REP provides regulatory insights, strengthens supply chains, supports post-market activities, and offers access to expert networks. Therefore, choosing the right EC-REP is crucial for EU market success.

Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner Read more

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.

Lumis Is Launching a New Authorised Representative Service Read more

Outsourcing clinical trials has become an increasingly prevalent trend not only in the pharmaceutical industry but also increasingly at small to midsize biotech and medical device companies. As the complexity of drug development and regulatory requirements continue to grow, companies are turning to specialized external partners to conduct clinical trials more efficiently and cost-effectively.

Trends in Outsourcing Clinical Trials: A Comprehensive Overview Read more

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.

Overview of the Orphan Designations Webinar Read more

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. 

Regulatory Pathways for Medical Device Clinical Trials Read more

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.

Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations Read more

Medical cannabis research is evolving rapidly. In this article we examine the recent developments and challenges faced, focusing mainly on Europe and the US.

Medical Cannabis Clinical Trials Read more

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

Lumis 10-Year Anniversary – The Lessons we have learned Read more

We sat down with Heike Schön our CEO 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!

First experience with CTIS – Interview with Heike Schön Read more