Berichten

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

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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.

Atomium Brussels

Inaugural RAPS Regulatory Conference Europe 2019 in Brussels

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The inaugural Regulatory Affairs Professionals Society (RAPS) annual Regulatory Conference Europe was organized in Brussels, 13-15 May 2019. The next Convention will be held again in Brussels in May 2020.
At this first European Convention more than 300 regulatory professionals participated. MARACA International helped organize a strong European program covering regulatory topics in pharma, medical device and IVDs fields. The European Commission, Competent Authorities and Notified Bodies were well represented. The EU Commission representative gave an update on the roll out of the MDR and the IVDR.
Dr. Luc Van Hove organized a session on SME concerns with the transition of their IVDs to the IVDR. We had an audience of 50 participants and good discussions on what the stuck points are for SME while migrating their IVDs to the new IVDR. Key issues were available notified bodies; How can the equivalency road be used; What is sufficient clinical evidence; How to run a Post-market Performance study.