Lumis blog posts
Global In-Country Representation: Convert Your Global Ambition to Global Reality
Navigating the complex landscape of medical device regulations across different countries can be a significant challenge for any company. To help our clients overcome these challenges, we are excited to announce the expansion of our in-country representative services to include key markets worldwide.
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Why You Need a Legal Representative for Clinical Trials in Europe
If your company is based outside the EU or EEA and you’re planning to conduct a clinical trial in Europe, there’s one thing you absolutely need to have in place before you get started: a legal representative. Here we explore the reasons for this and the options available.
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A Vigilant Ally – How Authorised Representatives Support Vigilance Activities
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.
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Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner
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.
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Lumis Is Launching a New Authorised Representative Service
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.
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Trends in Outsourcing Clinical Trials: A Comprehensive Overview
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.
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Overview of the Orphan Designations Webinar
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.
Regulatory Pathways for Medical Device Clinical Trials
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.
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Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations
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.
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Medical Cannabis Clinical Trials
Medical cannabis research is evolving rapidly. In this article we examine the recent developments and challenges faced, focusing mainly on Europe and the US.