MARACA International participated in the annual Safe-N-Medtech OITB consortium meeting in Barcelona. Dr. Luc Van Hove presented the work package
Dr. Luc Van Hove from MARACA International participated in the IMDEA meeting in Madrid on Magnetic nanoparticle-based medical devices towards the clinic. This scientific and clinical meeting transitioned the NoCanther clinical study from REFINE to the Safe-N-Medtech consortium for further development. At the meeting the status of the development of paramagnetic iron nanoparticles was reviewed. Details were presented on how to produce stable iron nanoparticles of the right size and the right properties. The establishment and validation of the clean room manufacturing of the iron nanoparticles was discussed. The status of the preclinical testing in vitro and in vivo in different animal models was reviewed. The first in-human pancreatic adenocarcinoma patients of the NoCanther clinical study which are treated with the Resonant Circuits Limited (RCL) hyperthermia therapy were reviewed. The treatment was found to be safe and possible. The NoCanther clinical investigation is transitioning from REFINE, which comes to an end, to Safenmt for further study progression. MARACA presented at the meeting the regulatory and clinical investigation requirements for a Pre-CE conformity study to establish the safety and performance of the RCL NTT hyperthermia device. Moving this new treatment from the development phase to the clinic is an exciting achievement. Everyone involved deserves congratulations for their hard work!
MARACA International is participating in the Management Committee meeting in Braga, Portugal on 4-5 May of the European Safe-N-MedTech consortium. Dr. Luc Van Hove is presenting the progress report of the regulatory workgroup and presents a customer survey on the support needs of nanotechnology companies. These nanotechnology companies from Europe, the Americas and South East Asia were surveyed during the Business Review Webinar organized by MARACA International in March on the regulatory roadmap for registration of nanotechnology-based medical devices in Europe. The Webinar is still available in 2022 for on-demand review and can be accessed via the following link: BRW:
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.
“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.
MARACA International wishes
our clients and community
a Merry Christmas and a Happy and Healthy 2022.
Thank you to all the volunteers who are keeping up with the relentless CORONA waves and continue to booster vaccinate our community. MARACA also supports the efforts of De Warmste Week, Physicians without borders, Mercy ships, UNICEF, Fight against Cancer, Fight against MS and local nature preservation initiatives to build a better world for us all.
Dr. Luc Van Hove from MARACA International participates in the local vaccination campaign in Rotselaar. “I felt compelled to help our local vaccination effort in Rotselaar to protect my community from the COVID-19 pandemic. It feels great to be part of this excellent core team of volunteers. The vaccination program and vaccination center are well received by our population. We are expecting to reach a vaccination level of 90% of our people. It is a wonderful experience to be part of this local effort. I’m sure that this effort is strengthening our community sense and will prepare us better for the climate change efforts needed in the future. MARACA International supporting this local vaccination campaign in Rotselaar is an effort well spent”.
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.
Dr. Luc Van Hove from MARACA International chairs three IVD sessions at the RAPS 2020 Euro Convergence meeting. This is the annual European convergence of regulatory professionals, which was scheduled in Brussels this year, but due to Corona, is converted to a full virtual meeting. Being part of the organizing scientific committee, Luc says “I’m excited about the scientific content of this meeting, you will enjoy it”. “It was a unique experience to move the presentations to this virtual environment”.
Luc is chairing “Regulatory hurdles to overcome to introduce nanotechnology-based IVDs and medical devices to the European Market, a Safe-N-MedTech concern”, 27 Oct. at 9:45-10:15 CET. This sessions reviews the regulatory issues and possible solutions to bring nanotechnology-based devices to the European market. The Safenmt consortium will discuss with the audience how to best support such devices to the market using two test cases and Luc will introduce the audience to the hurdles and possible regulatory roadmap for such nanotechnology-based devices.
The next session which is chaired is called “Implementing practices to comply with the IVDR”, 27 Oct. at 13:30-14:30 CET. Dr. Armin Ritzhaupt from the European Medicines Agency (EMA) will present the European Commission’s view on how to implement the new IVDR.
Hearing it directly from the EMA and from industry will stimulate an interesting discussion with the audience.
The last session is “What is sufficient clinical evidence for IVDs in preparation for the IVDR?”, 28 Oct. at 13:30-14:30 CET. Dr. Julien Senac from TUV SUD will represent the Notified Body view and Luc will present the industry perspective. This is a hot topic, which will create a lot of interest and discussion.
After the session presentations there will be a Zoom chat room available to meet the speakers and discuss your personal questions. This will give you the real congress experience.
During the congress there will be also other chat room opportunities to exchange ideas and interact with RAPS members.
As you can see this will be a great meeting to participate in for regulatory professionals.
See you at the 2020 RAPS Euro Convergence.
MARACA International received the 2020 Global Excellence Award, recognizing our focus on delivering Service Excellence.
Based in Flemish-Brabant, MARACA International is a consulting firm which provides executive-level services to medical device and pharmaceutical companies and clinical laboratories across the globe. Following MARACA recent success in the 2020 Global Excellence Awards, we got in touch with CEO Luc Van Hove to find out more.
Founded in 2017, MARACA International have focused on providing the best in-class regulatory, quality and clinical services to medical device manufacturers, clinical laboratories, pharmaceutical companies and notified bodies since inception. To start, Luc begins by offering us an insight into the firm’s specialisms and their typical clientele.
“Medical devices placed on the European market must meet the requirements of their respective regulations, so by ensuring the manufacturer has obtained the CE mark label, we are helping them provide the evidence they need to prove of their compliance. With full management of the manufacturer’s regulatory affairs activities, small and medium size manufacturers can outsource all for effective regulatory affairs management. With further hands-on training on specific parts such as risk management, clinical evidence, performance evaluation reports and the composition of technical documentation, we can facilitate your conformity assessment and understanding of the requirements for CE marking.”
“As well as SME pharmaceutical and medical device companies, we are working through our network of contacts to deliver excellence to all. In regards to our client approach, we focus on their bespoke needs, delivering interactive training sessions to help them focus on the practical implementation of their products. Having introduced a series of training modules around the European medical device regulation, our training sessions can be delivered in-class or can be accessed digitally. Collectively, it’s our mission to help bring medical technology, such as nanotechnology, from concept and development through to medical device registration. Working with our international client base we are committed to improving lives through service excellence.”
Working in a thoroughly competitive industry can make life difficult for some companies when it comes to distinguishing themselves from others. However, with more than 20 years’ experience in the field, MARACA International can offer a unique service as a medical practitioner. Luc added “Unlike many of our competitors in the region, we can advise in the development of companion diagnostic products and offer health hazard assessments for patient complaints.”
Currently, the outbreak of COVID19 is having a major impact on the operations of businesses across the globe. In particular, the pandemic has changed the ways in which MARACA are communicating with both clients and staff as Luc further explains. “The ongoing coronavirus crisis has resulted in many businesses working remotely and we are in a similar boat. Conducting virtual meetings is far from ideal but with tools such as Zoom and Microsoft Teams available we have been able to maintain contact with our clients throughout these difficult times.”
Unlike many others, recruitment in the medical and pharmaceutical industries in these current times is vital as we aim to fight coronavirus, as Luc goes on to explain. “We are looking for experts interested in working within our MARACA network, and currently with the coronavirus pandemic we are keen to recruit more faces as we look to play our part in putting a stop to the spread of this disease.”
Finally, Luc comments on the future of MARACA International and the plans in place to ensure the firm remain one of the leading clinical and regulatory affairs consultancies in Europe. “Going forward, we are focused on supporting our clients with innovative approaches as we look to get through the coronavirus outbreak. Furthermore, bringing innovative nanotechnology-based devices in a compliant way to both the European and US markets, will be a key focus of ours.”