EAAR RMD Meeting 2024, Brussels 26 - 27 February 2024

EAAR RMD Conference 2024 on regulations of medical devices, Brussels 26 – 27 February

Dr. Luc Van Hove participates, as representative of the European Authorized Representative (EAR) Silimed BV NL  at the European Association of Authorized Representatives (EAAR) in the RMD Conference in Brussels, 26 – 27 February. The conference is focused on industrial challenges and key regulatory developments for medical devices that are important for Authorized Representatives to know. Of particular interest are the sessions on the latest developments on the MDR and IVDR regulations and the EMA role in the MDR/IVDR framework for combination products. Additional national requirements beyond the MDR and IVDR will also be highlighted. Positive and negative experiences with the Notified Bodies will be discussed. Legal aspects of the MDR and IVDR will be reviewed and the potential impact of AI will be assessed. Of particular interest to MARACA International are the sessions on Clinical evaluations and scientific validity as their pain points will be reviewed. Also of interest are the discussion of a practical approach to postmarket surveillance and vigilance requirements. Last but not least, the status of the EUDAMED database will be presented.

Brandenburg gate during Berlin Marathon 2023

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

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

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.

Workshop on Hyperthermia in Oncology

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.

Heirbaan, Rotselaar

Klimaatdag – Rotselaar

Kom je ook naar de Klimaatdag-Rotselaar, 23 April 2023, in de Sportoase Den Toren?

You are invited to the Climate Day of Rotselaar, 23 April 2023, Sportoase Den Toren.

Organized by the MAR – Milieuadviesraad van Rotselaar

including Dr. Luc Van Hove of MARACA International

Met:

  • Infomarkt met slimme oplossingen voor energiebesparing
  • Lezing van Pieter Bousemaere over de 10 klimaatacties die werken
  • Voorstelling Klimaatplan van Rotselaar met interview door student van het Montfort college

With:

  • Infomart on smart solutions for energy savings
  • Presentation by Pieter Bousemaere on the ten climate actions that work
  • Presentation of the Climate Plan of Rotselaar with an interview by a student at the Montfort college

The ten climate actions that work for you are:

  • Inform yourself
  • Influence your environment
  • Influence your government
  • Select green electricity
  • Use electricity wisely
  • Select the right heating
  • Select the right mobility
  • Limit flying and compensate

De tien klimaatacties die werken zijn:

  • Informeer jezelf
  • Beïnvloed je omgeving
  • Beïnvloed je overheid
  • Kies de juiste elektriciteit
  • Spring verstanding om met elektriciteit
  • Kies de juiste verwarmingsbron
  • Kies de juiste motor
  • Beperk vliegreizen en compenseer

Tijdslijn:

12 u infomarkt met o.a:

  • Workshop veggie zero waste Koken
  • Zonnepanelen, thuisbatterijen en laadpalen
  • Warmtepompen en isoleren
  • Repair café
  • Energieloket en premies
  • Deelwagens en mobiliteit

14 u: ECoOB productie hernieuwbare energie door burgers

14.20 u: Lezing Pieter Bousemaere

16.30 u: Interview Klimaatplan Rotselaar

Time Line

12 hr.: Infomart with

  • Workshop veggie zero waste cooking
  • Solar panels, home batteries, charging stations
  • Heat pumps and isolation
  • Repair Cafe
  • Energy counter and premiums
  • Share cars and mobility

14 hr.: ECoOB production of renewable energy by citizens

14.20 hr.: Lecture by Pieter Bousemaere

16.30 hr.: Interview Climate Plan Rotselaar

We need to reduce Carbon emission by 55% within the next 7 years (2030) per the European Green Deal regulation.

The MARACA International office is already carbon neutral with its solar panels, heat pumps, home batteries and led lights. What are you doing to preserve a livable world for your grandchildren and to become carbon neutral?

Het MARACA bedrijf is reeds koolstofneutraal met zijn zonnepanelen, warmte pompen, thuis batterijen en led verlichting. Wat doe jij om een leefbare wereld na te laten voor je kleinkinderen en om koolstofvrij te zijn tegen 2050?

 

 

Vall d'Hebron Hospital

MARACA at Safe-N-Medtech meeting in Barcelona

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

IMDEA building, Madrid

NoCanther study moves magnetic nanoparticle device towards the clinic

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!

Tenoes, Braga, Portugal

MARACA presents regulatory update at Safe-N-Medtech meeting in Braga Portugal

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:

Nanotechnology-based medical device registration roadmap for Europe

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

“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.