With a dewy new certificate, we can now look forward to the upcoming exciting projects and innovations: In May, an MPDG refresher course was held by the Charité. In order to maintain the quality of our services, but also because there are corresponding legal requirements, MEDIACC employees regularly undergo refresher courses on all our topics – because delivering each of our services only in top quality is an elementary part of our philosophy. Therefore, learning never stops for us: After the course is before the course!
We have just received approval to conduct a purely digital clinical trial of a medical device. Reconciling the highest security requirements in a multi-centre cyber study integrates disruptive technologies for digital health applications with optimised processes. Our “crown jewels” are protected – we thank our competent IT partners for securing and certifying them according to ISO standards.
Today, the transitional arrangement for the placing on the market and clinical trials of medical devices ends and the EU MDR 2017/745 must be applied throughout Europe, supplemented in Germany by the national requirements of the Medizinprodukterecht-Durchführungsgesetz (MPDG), which significantly exceeds the requirements of the EU MDR. In vitro diagnostic medical devices are still exempt. The regulatory requirements for clinical trials are increased in favor of patient safety-requirements that we at MEDIACC have already implemented for innovations.
We have all seen the incredible speed with which vaccines have gone from laboratory development to being safely tested in humans and, after rigorous testing, administered to over a billion in under 6 months. This is made possible by the global networking of scientists, generous and pragmatic funding and digitalisation.
MEDIACC is an independent, owner-managed scientific institute recognised by the Federal Joint Committee and the BfArM, which was founded in 2013. Here, clinical trials are designed, planned, conducted, evaluated and published. The focus is on the digital planning and implementation of multi-centre clinical trials of medical devices, new diagnostic methods and medicinal products. This has enabled and continues to enable clinical trials to be carried out even in times of complete exclusion of personnel who are not absolutely necessary for the non-deferrable treatment of patients in hospitals.
The high procedural and ethical demands of clinical trials and the global resounding benefits are clear. MEDIACC has uniquely allowed purely digital trials to continue in times of complete lockdown. This was made possible by the consistent development of a digital infrastructure that demonstrably ensures data security and integrity of particularly vulnerable data under high regulatory demands.
The Charité Entrepreneurship Summit attracted top international speakers and discussants. In the medical sector, developments and innovations are taking place at an ever faster pace, with fewer and fewer people providing increasingly expensive and complex services to more and more people. Thank you for this exciting event, which we were happy to attend!
On 22.04., the first MEDIACC employees received their vaccination against SARS-CoV2. Thus, we can now pursue our valuable profession, namely to conduct clinical studies also for the containment of the current pandemic, with even more security. Currently, we have 3 active COVID-19 trials ongoing, and the number is increasing. We are prepared for the new challenges and look forward to contributing to many new innovations in the fight against COVID-19 and other diseases!
In vitro diagnostic (IVD) devices – such as new tumor markers or tests to detect SARS-CoV2 – are also facing more stringent requirements to demonstrate their utility. REGULATION (EU) 2017/746 on in vitro diagnostic (IVD) devices will soon apply. This also tightens the requirements for performance studies, i.e. the clinical studies that must be carried out to demonstrate the basic safety and performance requirements.
Just in time for Easter, we refreshed our knowledge of in-vitro diagnostics at TÜV Süd and had ourselves certified. We are ready for the new requirements!
We wish all of us a happy Easter and all our loved ones good health for the coming months.
The time has come: Our CAMOped study with OPED GmbH as sponsor can now be found on the G-BA website. The study concept, our study centres and investigators as well as the trial guideline can be read at the following link:
We are pleased that the study continues to run so well and would like to thank our investigators, the study teams and all participants for the good cooperation!
One of our customers has recently submitted his DiGA application to the BfArM with our support. 38 questions on §§ 5 and 6, 78 questions on § 4 para. 6 (requirements for data protection and safety), 82 questions on the application for inclusion in the DiGA directory according to § 139e SGB V – there is a lot of work behind it. Together, we have mastered the challenge and will very soon tackle the next DiGA application in order to actively accompany the rise of meaningful digital health applications as medical innovations.
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