Berichten

Brandenburg gate during Berlin Marathon 2023

MARACA International at Berlin Marathon 2023 and 24th IMDRF Stakeholder Workshop

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It is great to start our visit to Berlin with the Berlin Marathon 2023. It reminded me of the marathons I’ve run in the past and all the excitement around such an event. Due to the Marathon I had to do a walking marathon to see the Berlin monuments. The Brandenburg Gate and the Reichstag building were located within the Marathon zone, which is super for the runners, but difficult for tourists. The weather was great so the long walk back and forwards though the Tiergarten was very enjoyable.

Next, MARACA International and Silimed participate in the IMDRF-Stakeholder Workshop and Stakeholder forum on 25 – 26 September. We’ll follow the regulatory developments around breast implants. What is expected for performance of breast implants and what level of side effects are acceptable. Also, patients will participate as stakeholders to express their own views. It will be a great meeting with all these regulatory experts from around the world to talk about the regulatory progress they have made. I’m looking forwards to the sessions.

Bilbao Guggenheim Puppy

Safe-n-Medtech 54th month Management Committee meeting in Bilbao, Spain to start the OITB Pathway

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Safe-n-Medtech calls its 54th month management committee meeting in Bilbao on 20 – 21 September 2023 to start the OITB Pathway.

All nine work package leaders of safenmt will present the final progress of their work packages.

Dr. Luc Van Hove of MARACA International , as WP7 Leader, Regulatory and Ethics, will present the final update of the medical device and IVD harmonized standards to be used for the development of nanotechnology-based medical devices. He will also present the report on applying ethical behavior in the development of nanotechnology-based medical devices.

Moreover, Luc reviewed the Quality Management Systems (QMS) and Technical Documentation (TD) of several test case partners, identified gaps and proposed resolutions to bring their QMS and Technical Documentation into compliance with the MDR, the IVDR or ISO 13485:2016. He developed regulatory strategy plans for several partners and improved the risk documentation of several nanotechnology-based devices to be in compliance with ISO 14971:2019. Luc also developed scientific validity reports with systematic literature searches to support the clinical evaluation of some medical devices and IVDs and he was a medical member of the NoCanther clincial trial Safety Board.

MARACA International is also heavily involved in the creation of the OITB Pathway portal.

The OITB Pathway company is created as a single-entry commercial enterprise portal to link medical device and IVD clients with partners who offer different specialized services to research and develop medical devices and IVD to a successful registration in Europe.

MARACA developed the Quality Management System for the OITB Pathway company in compliance with ISO 9001:2015.

MARACA International will offer its regulatory, quality, and clinical services through the OITB Pathway to the many clients in need of such services.

Vall d'Hebron Hospital

MARACA at Safe-N-Medtech meeting in Barcelona

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

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Nanotechnology-based medical device registration roadmap for Europe

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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.

Biocompatibility testing

MARACA training on nanotechnology-based medical device biocompatibility testing

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“Nanotechnology-based medical devices require special attention to biocompatibility testing.”

Dr. Luc Van Hove of MARACA International will train the Safe-N-MedTech consortium partners on the regulatory requirements in Europe for biological toxicity testing of nanotechnology-based medical devices. This training is an introduction to the Medical Device Regulation 2017/745 and the REACH Regulation 1907/2006, last amended in 2021, which specify how nanotechnology-based medical devices need to be handled. The training will then introduce the EN ISO 10993 series of harmonized standards. It starts with the review of the current version of EN ISO 10993-01:2020. The focus will be on defining the list of the chemical components of the final product and on developing the biological toxicity risk documentation. Depending on the location and duration of the contact with the patient and on the toxicity of the component a set of biocompatibility tests will have to be performed. For nanotechnology-based medical devices these harmonized standards are applicable. However, due to the nature of the nanomaterials the general information of the standards are not sufficient and specific tests might have to be developed. Hence, special attention needs to be paid to biocompatibility testing for nanotechnology-based medical devices.