Berichten

Workshop on Hyperthermia in Oncology

/in /by

MARACA International and Safe-N-Medtech participate in the workshop on Hyperthermia in cancer treatment, organized by Vall d’Hebron Hospitals, Barcelona, Spain.

Dr. Luc Van Hove presents the European regulation of medical devices and in vitro diagnostics from a rare disease’s perspective.

Pancreatic cancer is a rare disease. It is therefore difficult to include sufficient study subjects for a rare disease clinical investigation. At the European chaired IMDRF congress in Brussels 27 March 2023, real world data collection was discussed as an option for clinical studies of rare diseases. During this Hyperthermia workshop we’ll examine this possibility for pancreatic cancer as a rare disease. Specifications for post-market clinical follow-up studies will be considered. Interaction with notified bodies and the Spanish Competent Authority will be part of this discussion. It is exciting to be in the forefront of this new hyperthermia treatment for rare cancers.

Vall d'Hebron Hospital

MARACA at Safe-N-Medtech meeting in Barcelona

/in /by

MARACA International participated in the annual Safe-N-Medtech OITB consortium meeting in Barcelona. Dr. Luc Van Hove presented the work package

Read more

Nanotechnology-based medical device registration roadmap for Europe

/in /by

Nanotechnology-based medical device registration roadmap for Europe presented by MARACA International and Safe-N-Medtech at Business Webinars on 15 March 2022, 3 PM CET.

This regulatory roadmap for nanotechnology-based medical devices and IVDs is the same as for conventional medical devices and IVDs.  However, for the nanotechnology-based devices additional analytical performance characterization, biocompatibility testing,  risk management and labelling are required. The different regulatory steps are highlighted, as well as the current challenges, such as incomplete intended purpose statements, what biocompatibility testing is needed and what is sufficient clinical evidence. Many small medical device and IVD companies are not well prepared for the transition to the new regulatory requirements.

The key steps of the regulatory roadmap are reviewed: Manufacturer’s role, scientific validity, analytical performance, clinical performance, clinical evidence, clinical performance report, post-market clinical follow-up, conformity assessment, GSPRs, certificates and EUDAMED registration.

Participants will learn what the required regulatory steps are for the development of a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations. The impact of the REACH and CLP regulations on labeling will also be highlighted.

When you are developing nanotechnology-based devices this webinar “Nanotechnology-based medical device registration roadmap for Europe” is a must for you to stay compliant with the current European regulations.

Regulatory Roadmap for the EU registration of nanotechnology-based medical devices and IVDs is published by MARACA International for the Safenmt consortium

/in /by

Dr. Luc Van Hove of MARACA International developed a regulatory roadmap for NT-based MD.

Luc developed a regulatory roadmap for the EU registration of Nanotechnology (NT)-based medical devices (MD) and IVDs. This roadmap was commissioned by the Safenmt consortium. For NT-based MD and IVD, as for conventional MD and IVD, this regulatory roadmap is the same.  However, for the NT-based MD additional analytical performance characterization, risk management and labeling is required. The report is now used for training of Safenmt consortium partners and will be presented externally at nanotechnology scientific meetings.

The objective is to educate the nanotechnology field on the required steps for developing a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations.

Within the next two weeks two Safenmt trainings will be organized.

A first external presentation of the regulatory roadmap for NT-based MD will be at the NanoMedSpain symposium on 20 May 2021, which has the new MDR as symposium topic.

Another session is planned for the ETPN (Nanomedicine European Technology Platform) conference on 7-9 September 2021 in Switzerland.

Safe-N-Medtech consortium starts

Safe-N-Medtech Consortium kickoff

/in /by

Safe-N-Medtech Consortium kick-off meeting in Bilbao.

The Safe-N-Medtech Consortium initiative kicked off 2-3 May in Bilbao, in a meeting hosted by Osteba, the HTA Unit of the Health Ministry of the Basque Country (Spain) in collaboration with BIOPRAXIS-BIOKERALTY. The project is coordinated by TECNAN (an SME from Navarra, with great experience in Nano products), together with BIOPRAXIS-BIOKERALTY (the research branch of the global health companies Keralty and Praxis).

Safe-N-Medtech is an Open Innovation Test Bed (OITB) initiative from the European Commission, a new and challenging approach towards upscaling the use of nanotechnologies in Europe and abroad. It represents a European investment of 18M€ over 4 years.

More than 50 founding Consortium members, including MARACA International, gathered in Bilbao, coming from 28 entities and from 13 countries to refine the basis of the collaboration, and set the scene for the first years of the Project.

Ambition and strategy

Society and clinical practice pose a growing demand on novel biomaterials, ICT, micro and nanotechnologies for innovative medical devices and in vitro diagnostics (Medical Technologies-MTs). In addition to the challenge of time, the new technologies are subjected to other pressing factors such as qualification, regulation, cost, biocompatibility and the need to be applicable worldwide. In the most recent years it is obvious that nano-enabled MTs can be applied in nearly every medical area, with a major presence and increased importance in cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopaedics, and dentistry.

SAFE-N-MEDTECH with MARACA International will build an innovative open access platform to offer to companies and reference laboratories, the capabilities, knowhow, networks and regulatory and clinical services required for the development, testing, assessment, upscaling and market exploitation of nanotechnology-based Medical and Diagnosis Devices.

SAFE-N-MEDTECH will offer a multidisciplinary and market oriented innovation approach to SME´s, Healthcare providers and Industries for the translation to the market of MTs, based on a deep understanding and knowledge of the material nanoproperties, their advanced use and applications in MTs and other aspects involved in MTs safety (electric compatibility, electromagnetic properties, etc).

Who s in?

There are 28 partners in Safe-N-Medtech, including MARACA International, a great challenge for management, but a huge opportunity to address all the key challenges to come ahead. Research Institutes, Small and larger companies, Associations, Health Technology Assessment experts, Hospitals and Care centres are amongst the partners, and ensure the project can cover all the relevant aspects of the translation of nano-enabled medical technologies.

What s next?

SAFE-N-MEDTECH starts its journey by ensuring its validity with four test cases. During the first years of the initiative, the partners will develop their services and test them, so that in four years from now, it becomes a self-sustainable and competitive services platform for companies to test and ensure their nano enabled medtechs are safe to use!

 

For more info on the project:
Coordinator: Tamara Oroz, TECNAN (tamara.oroz@tecnan-nanomat.es)
Scientific Lead: Angel del Pozo, Biopraxis –Keralty (angel.delpozo@keralty.com)
Communication: Anaïs Le Corvec, Aura Costa (info@cebr.net)
MARACA International, Partner for Regulatory and Clinical services, (www.maracainternational.com; lucvanhove@maracainternational.com)