Digital health applications (“medical apps on prescription”) need studies of high quality for their benefit to be listed as such by the BfArM and for doctors to want to prescribe them later on. In cooperation with other members of the German National Association for Digital Health Care, we are voluntarily involved in the Evidence Working Group for the sustainable development of groundbreaking technologies for our patients.
We at MEDIACC are specialists when it comes to clinical studies and clinical evaluations of medical devices – including DiGAs. We are pleased to be able to support the Spitzenverband Digitale Gesundheitsversorgung e.V. as an active member with our expertise.
In the course of moving into the new, larger offices, we switched to green electricity. In this way, we are making a further contribution to climate protection and the expansion of innovative and renewable energies.
We, too, try to make our contribution to equality for all genders, and this should also be reflected in our work. Only recently we submitted our first gender-neutral application to the Ethics Committee and had it successfully advised. More are on the way – because good ideas, good work and good innovations know no gender.
In order for all our staff to be able to continue their work with the study patients where it is unavoidable without endangering themselves or others, Covid 19 vaccinations were started as early as possible at MEDIACC. In the meantime, all staff members have received their follow-up vaccination and have also "served" the two-week waiting period. This means that we can now get back to patient care and be there for our patients in person! We hope that the vaccination tempo will continue to increase worldwide and that everyone who wishes to receive their vaccination will be able to do so as soon as possible.
All of our 3 PhD students presented their innovative scientific results at international congresses last week and were available for discussions from the expert audience: Mechanisms of action of therapeutics in the pipeline and results from randomized controlled trials. Supporting young talents is a top priority for us – we are proud of you!
Electronic consent forms (eConsent) are becoming more and more important with the increasingly decentralised approach of clinical trials. In alignment with the experts of the European CRO Federation (EUCROF), we are up to date and can continue to conduct clinical trials according to our standards in the highest quality DSGVO compliant and completely digital.
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.
This year, Dr. Schmidt-Lucke is again holding a doctoral course for enthusiastic medical students. Together, key qualifications for research and teaching are acquired and taught, so that everyone can take away from the course what is needed on the further path in medicine and science – thus, highly qualified, talented specialists for the innovations of tomorrow are created through practical support.
At its meeting on January 21, 2021, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) decided that our study concept complies with the requirements of the “Guideline of the Federal Joint Committee” („Richtlinie des Gemeinsamen Bundesausschusses“). This means it meets the key points of the trial guideline and is thus suitable for generating the data required for the method evaluation in accordance with Section 135 (1) of the German Social Code, Book V (SGB V).
We are overjoyed! The decision will soon be published on the G-BA website (www.g-ba.de).
Many thanks to all involved for the efforts and the great input!
Wishing you and your family a happy, prosperous and blessed Lunar New Year of the ox.
May we see each other again in not too distant future under better circumsatances.
Young people and children are currently being deprived of as much as they were last at the time of the war! Due to the current measures, especially active young people are currently experiencing a feeling of greater isolation and confinement. We at MEDIACC financially support the efforts and incentives of sports and leisure clubs to enable responsible outdoor sports activities until the warmer season. The signal for the young generation: Get out there! Get moving! Experience something! And get fit for the coming sports season and your friends!
We are proud of all the helpers who followed our call and initiated, organised and financed by donations from Rotary and the MEDIACC to turn this incredible number of trees into a great planting campaign. We have put our responsibility into practice across generations. Our forest is growing!
Air cleaning devices filter the smallest particles from the room air. Standardised tests are used to measure how many particles of a defined size are removed from the room air. MEDIACC supports manufacturers of such air purification devices in these tests. Result: From 5.000.000 particles (also in virus size!) only 20-30 particles get into the ambient air when using the air filter – practically nothing. Does this make personal contacts possible again? Yes! The certified effectiveness of this filter enables safe contact in areas where personal meetings are necessary. We are proud to provide another building block in the fight against the pandemic and return to normality with personal meetings!
The Working Group State Europe School Berlin receives the Europe Award Blue Bear of the State of Berlin! With this award we are honoured for our long-lasting work in civic engagement to ensure European and multilingual education for about 3500 children and young people. For a strong Europe together!
At last! The first digital health applications (DiGA, medical apps) are available on prescription. This is made possible due to clear quality criteria in the evaluation of medical benefits or positive effects of care, which then lead to listing in the DIGA directory of the BfArM. We are proud to make our contribution here as well. Thus, innovations are directed straight at those in need!
Off into the woods – for all those who inherit our earth! MEDIACC supports the Schutzgemeinschaft Deutscher Wald e.V. with organisation, personal participation and a donation in a unique project: Together with 100 dedicated young people, 3.000 red oaks will be released into the wilderness in a large planting campaign tomorrow, October 24. Thus, the world will be made a little better with united forces – under strict corona safety measures. Because saving the climate is in our hands, MEDIACC is getting involved!
While the virus is once again making life difficult for everyone in Berlin, we are looking ahead to the future beyond our cloth face masks and continue working quickly. Our G-BA study keeps rolling, new studies are ready for take-off. In one of them, we will finally launch a DiGA for a customer. The first scientifically recognised DiGAs are already listed as aids – and rising! We hope that a lot will happen in this field in autumn.
Whether our customers go on holiday or not, whether they take their summer break or not – here at MEDIACC there is no “summer slump”. We are staffed continuously and, as usual, we are there for everyone, even during the holidays.
Not new is the realisation that many published research results are wrong or even negligently falsified. “Flexibility” in the analysis and presentation of the collected data allows for a wide range of interpretations. The tendency to do so is due to the fact that the incentive to do science is no longer the same as it used to be: without regular publications, the career ladder shakes, publishing is done out of necessity, not out of curiosity and joy. Not infrequently, even private differences of opinion, deadlocked views or the insistence on standpoints and expectations are behind the essays. All this leads to a flood of bloated articles in minor journals that do not advance science. Meaningful science requires better networking of experts from different disciplines, linking several levels of analysis and constantly questioning criteria. MEDIACC does its part and delivers clean, insightful scientific work.
Our NUB study, personally supervised by the G-BA, is gradually getting underway. One centre after the other is including patients and they are actively participating in the data collection. Great! Of course, such a study start is often a bit bumpy, but thanks to our many years of expertise, problems are quickly identified and solved. Many thanks to the G-BA for the good cooperation! Our customer, the sponsor, also shows us deep trust, for which we will, as always, return the favour with excellent work. Trust is never disappointed with us! Thus, we are looking forward to the further study inclusions and are curious to see how things will continue.
A few days ago, on 5 June, was World Environment Day. Few of you will have noticed this, as the world is currently taking care of other, supposedly more urgent problems. But what could be more important than the future of our descendants who will inhabit this world? Even in the face of the crisis, we must not lose sight of keeping our environment healthy. This is why MEDIACC is today participating in a project against climate change and for the reduction of our CO2 footprint, and it is literally “hands on” – together with a well-known environmental movement of young people.
As soon as the G-BA gives the last green light, our big NUB study will finally get underway. We can’t wait to get started and we’re champing at the bit! This multicentric, randomised, double-blind study on a promising innovative medical device will be great fun for all involved. Ready for take-off?
In COVID-19 times, clinical trials are much more difficult to manage: Some trial centres are no longer available, on-site monitoring is reduced to the bare minimum, visits have to be cancelled or postponed, often even recruitment stops. The start of new studies that are not aimed at the prevention or control of COVID-19 is sometimes delayed indefinitely. How do you deal with this? With appropriate Urgent Safety Measures (USM) and good fine-tuning between sponsor, trial centres and all other parties involved. The rights and health of the trial subjects take priority over all other concerns. We at MEDIACC take care of this: With a certificate from TÜV Rheinland, our employees are well prepared for the changed situation and are able to solve problems flexibly.
... the praised and feared MDR 2017/745 and the Medical Devices EU Adaptation Act-MPEUAnpG of 28.04.2020, which was passed in Germany. Most of our customers have already made the necessary changes. We at MEDIACC have already included the requirements for clinical studies according to the MPEUAnpG, apart from the increased administrative effort, in order to fulfil our mission: to simplify the market entry for medical innovations and increase patient safety! Clinical trials made in Germany!
Regardless of the ban on contact, we currently have one daily visitor to the MEDIACC office. Dachshund Ken keeps strictly to our office hours, but he does not think much of social distancing. Fortunately, he is not a transmitter, so we can safely exchange caresses with him. In times of contact prohibition and no-touch-policy, there is hardly anything more pleasant for us than to scratch Ken’s back or to watch him slumbering stretched out in the sun. We will probably not sizzle in the warm rays this summer on beaches on sun beds (which we have reserved with towels), but we should grant it to those who can. Right now, animals give us back a lot of what we miss. We are happy to have our permanent guest with us for a while.
... and we’re part of it! Recently another MEDIACC doctoral candidate passed her final examination and is now allowed to help her patients as a Dr. med. We are very proud of you and wish you all the best for the future!
After the Hackathon EUvsVirus was officially opened for Germany last night with a livestream warmup on Facebook, today the “hot phase” begins. We at MEDIACC are there, are in active contact with other participants and hope to be able to offer our expertise to one or more promising projects. In any case, DevPost, where the projects are hosted, is already full of colourful innovations, while in Slack, where the team members exchange ideas, the “brain market” does not come to a standstill. The hackathon will run until Sunday evening, followed by the great evaluation phase. We are aboard and full of excitement!
The European Commission has organised a pan-Europe “hackathon”: EUvsVirus, to connect civil society, innovators, partners and investors across Europe. Together, participants from all over Europe are to contribute ideas, processes and innovations to make the pandemic not only more bearable for all of us, but in the best case to tackle it faster combining our forces. The event will take place from 24 – 26 April. We from MEDIACC have joined as “Team” and “Problem Solver” with our expertise in the Health sector – after all, solving problems in the health care sector as a team is our vocation!
If you would like to be part of it, you can register here and learn more: https://euvsvirus.org/
We are looking forward to a successful Hackathon!
We would like to show our deep appreciation for all those people who are working really hard in these hard and stressing times. This also applies to all those specialists working in local Ethics Committees. We very much appreciate their hard work to consider our study plans for new clinical trials. This work is of ephemeral importance, as always. We are especially grateful to have our study protocols assessed and be given their advice to keep on helping patients in need. Everybody stay healthy and positive.
If you need us, we are here for you. Even in times like these. We at MEDIACC continue to advance projects and innovations unchecked and stand by our clients as usual, so that they do not lose the ground under their feet. We would like to thank all our clients for their trust in us and for the fact that we are also keeping our feet on the ground. We would also like to thank the politicians for clear communication and appropriate measures. Meanwhile, we continue to help diligently to bring new medical products onto the market for the health of our fellow human beings.
The media world is dominated by news about the COVID pandemic, with other reports sometimes disappearing into “lower drawers”. But this is no small matter for medical device manufacturers: The entry into force of the Medical Device Regulation, actually scheduled for 26 May 2020, is to be postponed by one year, EU Commissioner Stella Kyriakides announced last Wednesday. This still has to be approved in writing, which can be expected by the beginning of April.
For us, this means that projects starting from May 2020 are not yet covered by the new, stricter regulations. We – and our customers with their innovations – can continue to rely on the currently applicable laws one year longer.
Of course, this in no way means that we are getting lazy. If it were up to us, MDR could come tomorrow, we are fit – but experience shows that you can never be too prepared. Therefore, we are looking forward to continue to be diligent for our customers until the new start date (and of course beyond).
Although we still meet every day, transmission is not possible in our rooms: sterilising chemicals on the doors, no touching, interaction only at the recommended distance, no more sharing of objects. In this way we protect ourselves and our fellow human beings.
Does this mean that we are hampered in our work? Not at all.
In a situation that changes every hour, we have to think carefully about how to maintain our processes. It is not our way to panic, but acknowledging the seriousness of the situation, we have to be vigilant and keep a level head. Our goals stay the very same: To take good care of all our clients and to drive innovations forward for the ever-growing healthcare market. The current crisis takes strength from all of us, but it also makes us grow as a company. We try to go even faster: smoothing processes out, finding new modes of operation, working from different locations with more flexibility. Despite the severe circumstances, it is a challenge that we gladly accept.
We’ll be there for you – so you can be there for the patients.
As of 26 May 2020, in addition to the Medical Device Regulation (EU-MDR 2017/745), the requirements of the Medical Device Law Implementation Act (MPDG) are to apply – but so far, this is only available as a draft law. In Germany, it is to contribute, among other things, nationally valid implementation regulations and ultimately replace the MPG (Medical Device Law). For the so-called “other clinical trials”, this means a much more detailed regulation ... Fortunately, we at MEDIACC are fully conversant with this issue. We create innovations, including medical apps, together with key opinion leaders who have trusted us for many years – just like our customers!
It is no time for cinema, it is no time for a museum or going swimming, but it is certainly no time to stop working or to lose the joy of life. We support our customers flexibly in their joint projects and thank the German Federal Government for implementing the package of measures to support our economy in these days full of challenges and innovative solutions requiring our joint efforts.
We are pleased to hear that finally, German parliament regulated the implementation of the EU Medical Device Directive (MDR) into national medical device law with the resolution of the Medical Device Implementation Act (MPDG). It was high time for manufacturers and us as their partners who develop, test and make sure to deliver safe and innovative medical devices. The high standards of clinical research in Germany are maintained and patient safety will be strengthened. We will now be able to plan and set up future clinical trials beyond 26.5.2020. After final approval of the Federal Council the new regulations will immediately come into force.
Innovative medical devices that are so-called new examination and treatment method (NUB) according to § 137e SGB V and which have shown to be a potential required treatment alternative need to be tested within the framework of a testing guideline of the Federal Joint Committee (G-BA). Aim is to evaluate the medical benefit. In yesterday's press release, the G-BA publicly announced our next steps which will be submission of our study concept to the Federal Ministry of Health and to obtain the positive vote of the Ethics Committee. As independent scientific institution (UWI), we look forward to making our contribution to improve patient care and support companies to get their innovative products reimbursed in Germany.
Today, on 5 March 2020, the German Bundestag will finally vote on the draft bill to reform German medical device law, as it is to be adapted to EU requirements. The aim is to create a single EU market for medical devices with high quality and safety standards. For the BfArM (Federal Institute for Drugs and Medical Devices) and the PEI (Paul Ehrlich Institute) this would mean that they – instead of the state authorities – would take responsibility for excluding risky medical devices from the market. The counterfeiting of drugs and medical devices would also be made considerably more difficult.
Three motions by two parties on this issue will also be put to the vote, all three of which call for preventive or interception measures on possible weaknesses in the new laws. We are curious to see how it all turns out.
With the changes of the Medical Device Law Implementation Act (MPDG) draft, we are constantly discussing the impact of expected changes and increase of requirements amongst medical colleagues, clients and authorities, especially for former so-called “scientific studies”.
This new regulation specifies “other” clinical trials under Art. 82 (1) MDR (EU) 2017/745 and adds up to clinical trials under the German Medicines Act (AMG), clinical trials under Art. 62 (1) EU Medical Devices Directive (MDR (EU) 2017/745), and clinical trials on food supplements, cosmetics or similar.
We are now awaiting the adaptation of the new law that certainly by increasing needed qualifications and regulatory standards will make clinical studies more elaborate and expensive while increasing the safety and validity of data. We will keep you informed!
At last week’s specialist hearing on the Digital Health Applications Ordinance (DiGAV), the voices of various associations, health insurance companies and medical colleagues were increasingly heard. While some fear hurdles that pose too great a challenge, especially for smaller development companies, cost bearers and physicians are very concerned about the lack of concretisation of, among other things, the level of evidence and definition of the proof of the so-called “medical benefit”, analogous to the requirements for drugs, food supplements and other medical devices. We also fail to understand why double standards should be applied here and why the same evidence-based standards should not apply to medical programmes (medical apps) as to other medical devices? Germany should not degenerate into a test laboratory at the expense of patients.
We see a considerable need for improvement in the concretisation of these points, so that the potential of health apps on prescription can be fully exploited, in order to then support us in the identification, monitoring, treatment or alleviation quickly and sustainably in our daily treatment routine!
We would like to take this Thursday to thank all our software providers that make sure we get the best solution available – innovative and secure! Certainly not a picnic! MEDIACC has long arrived in the digital age, we are paperless and driving innovations forward ourselves. This would not be possible without all your valuable support. Thanks to all of you! Now let’s carry on and create more sound evidence of medical benefit to give back to the health community!
We are delighted that another doctoral student has successfully completed her doctorate and is now very deservingly treating her seriously ill patients with her doctoral degree! Congratulations – we are proud of you!
As of now, it is official: MEDIACC is registered as UWI (= independent scientific institution, Germ. “unabhängige wissenschaftliche Institution”) with the Joint Federal Committee (Germ. “G-BA”). We are looking forward to the new challenges to drive innovation with top experts and thank the specialists for the last incredibly productive working weekend!
Today, we should take a moment to reflect on the subject of cancer. Nobody wants it, so we don’t like to think about it, but it’s everywhere. MEDIACC supports new and innovative treatment methods against cancer and its many unpleasant side effects. We strongly encourage you to go for preventive medical checkups regularly and in time – we do so, too. Nobody wants to be surprised by cancer. So let’s stand tall for another successful year in the fight against it.
The forthcoming law implementing the Medical Devices Act (MPDG) will precisely define the roles of doctors in clinical trials: “investigator”, “principal investigator” or “head of clinical trials (LKP)” for clinical trials and so-called “other clinical trials”. The principal investigator will head a group of investigators at a trial site; the principal investigator-in-charge (CIC) will be appointed by the sponsor to manage clinical trials at several trial sites. The responsibilities and qualifications of the above-mentioned persons result from §3 (5) and (6) MPDG, which supplement Art. 2 No. 45 of the Medical Devices Directive (EU-MDR 2017/745).
We already have the qualifications for all these tasks and will be able to apply them “as fresh as a daisy” in the near future, after the passing of the law, in close contact with the Notified Bodies.
We are also in direct and close contact with the persons responsible for the ethics committees in order to be informed in good time whether the qualifications required for earlier studies according to §23b of the Medical Devices Act (MPG) will be tightened from 25 May 2020 for “other clinical trials” according to § 82 (1) EU-MDR 2017/745 or §3 (4) MPDG).
Getting our customer’s products on the health market and achieving high academic honours! We are so proud and congratulate our PhD candidate for passing the final doctoral examination with honours! It’s definetively partytime!
We are proud that our publication is still among 5 most viewed articles of 2019 published in PeerJ, in the area of Clinical Trials, Evidence-Based Medicine, Neurology and Orthopaedics.
We wish all customers, cooperation partners and followers a healthy and successful new year! 2019 was an exciting, highly successful year for us, and we would like to express our sincere thanks to all those whose projects we were able to lead to success, as well as to those whose support we could always count on. Today, immediately after the New Year, we at MEDIACC are already back for you. The many new projects we have tackled in 2019 deserve to be diligently supervised further on. There is a lot to do – and, fitting the season, it is finally cold in Berlin! But the hoarfrost on the roofs will soon be melting by the time we start the new year’s work. Full of zest for action, we are warming up for the challenges to come – for even more competence, performance and optimal project support in 2020!
On 26 May 2020, in addition to the Medical Device Regulation (EU-MDR 2017/745), the requirements of the Medical Device Law Implementation Act (MPDG) are to apply according to the current status (January 2020), which is currently only available as a draft law. The MPDG is to contain national implementation rules and concretisations for Germany and will replace the Medical Device Law (MPG).
In particular, the so-called “other clinical trials” (in the sense of MDR §82 para. 1), previously “Exceptions to clinical trials” (MPG, §23b), are also regulated in detail in the MPDG.
According to Section 3 (4) of the MPDG, a clinical trial is to be described as an “other clinical trial” if it “is not part of a systematic and planned process for product development or product observation, is not part of a clinical development plan, or is not conducted with the aim of demonstrating the conformity of a product with the requirements of Regulation (EU) 2017/745”.
Thus, if a clinical trial of a medical device is not to be planned and conducted within the framework of the clinical development plan – from initial feasibility studies to confirmatory clinical trials to post-market surveillance studies – but serves to answer scientific or other questions, this is an “other clinical trial” pursuant to Article 82 (1) of the MDR (EU) 2017/745.
The Medical Device Regulation (MDR) will be binding for all medical device manufacturers from 26.05.2020 onwards and the implementation of this regulation will pose immense challenges for the manufacturers, the medical contract institutes, but also the Notified Bodies. The 2nd amendment of the MDR of 25.11.2019 now grants a deferral to manufacturers of class I products. Class I products, which have MDD (Medical Device Directive) conformity and would have to be classified higher according to MDR, can continue to be marketed until 26.05.2024. Amongst others, providers of medical apps, which according to MDR are mostly classified as Class IIa or higher, but are already certified as Class 1 (according to MDD), will benefit from this extension of the transition period. Manufacturers of material products and surgically invasive products can also benefit from the change. However, all manufacturers are required to implement the new requirements of the MDR, including post-market surveillance, market surveillance and vigilance, as no deadline extension applies in these areas. The Medical Devices Implementation Act (MPDG), which will be discussed in the Federal Council on 20.12.2019, also raises many questions for the manufacturers and partners involved as to the exact implementation. We will also provide advice and support on the challenges of the MPDG.
Digitalisation is becoming increasingly relevant in clinical research. What are the consequences for patients, manufacturers and clinical contract research organisations, data protectionists and other parties involved in the planning and implementation of clinical studies?
MEDIACC will take part in the symposium “Digitalisation of clinical research – curse or blessing?” of the German Association of Medical Contract Research Organisations (BVMA) on Friday (29.11.19). The legal requirements of the DSGVO and the challenges of Medical Device Regulation (MDR) will be discussed. Present will be university research institutions, large pharmaceutical companies, the board of directors of the BVMA, representatives of the BfArM and lawyers.
We expect intensive discussions on the innovations which the Medical Device Implementation Act (MPDG), which will be debated in the Federal Council on 20 December 19, will bring with it. The implementation of new, very far-reaching laws such as the DSGVO, the MDR and the MPDG in the context of the changes brought about by digitisation requires a high degree of cooperation between many specialists in their respective fields. This is the only way to ensure the safety of our patients, the positioning of Germany in Europe and worldwide and to guarantee the manufacturers of innovative products for the health care market a sustainable expansion in increasingly demanding markets.
We are looking forward to the exchange with colleagues and would be pleased to inform you here about the next steps on the way to modern, safe, patient-oriented clinical research. We are also happy to meet for project-related discussions.
Medical aids – ranging from the bandage to the walking aid to cochlear implants – ensure the best possible and safe care for patients. In view of the innovations – for example, in the field of digital medical care with apps, the constant increase in knowledge through clinical studies and research and the increased quality requirements, mainly due to MDR – a continuous adaptation of the list of aids and nursing aids is indispensable. The new procedural rules describe how existing product groups can be continued in the list of medical aids and how manufacturers can introduce their products to the list of medical aids in order to enable reimbursement by health insurance funds. The further development and innovation of novel aids form the basis of high-quality care. The Rules of Procedure regulate the course of action for including new product groups and types in the list of aids, such as new types of hearing aids and app-controlled administrations.
The aim is to enable manufacturers to establish a regulated, structured and comprehensible process to ensure that the list of aids is always up to date. The legally insured persons, i.e. about 90% of the Germans, thus have fast, up-to-date and secure access to the latest medical developments and medical products. Germany will once again set high quality standards and remain an attractive market for medical device manufacturers. We look forward to taking you and your medical devices on the way to the medical aids directory in accordance with the new procedural rules.
1Rules of Procedure of the GKV-Spitzenverband according to § 139 paragraph 7 SGB V
A buzz about new super food that does wonders to the immune system or is recommended as the miracle detox product keeps haunting the media. Like ghosts, these claims tend to lack evidence. Clever and creative marketing strategies to boost sales? Or could there be solid scientific evidence about food that is good for our health?
Lots of these products are available in form of food supplements. What is that?
According to the food supplements Directive (Directive 2002/46/EC), food supplements are defined as foodstuffs that are meant to supplement the normal diet. Thus, they are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and others, designed to be taken in measured small unit quantities. The respective nutrients can be vitamins, minerals, herbal extracts and other ingredients.
These products are made according to the manufacturing standards, but that does not necessarily guarantee their effectiveness or even safety. So how can one be sure to buy a product that is both safe as well as effective?
A lot of food and food supplements available in the EU bear nutrition claims and/or health claims. A nutrition claim states that the product contains certain nutritional properties, such as “high protein”, “fat-free” or “source of omega-3 fatty acids”. A health claim is any statement on labels about a relationship between the product and health, pointing to possible health benefits resulting from consuming that particular product.
So, who decides who can get a claim and what is needed in order to receive one?
The area of health claims in Europe was unregulated until the end of 2006 when Regulation (EC) No 1924/2006 was published. Since then, claims about food and food supplements cannot be made unless they are authorised by the European Food Safety Authority (EFSA) and listed on a register. Any misleading by false claims without using scientific evidence will lead to serious legal consequences. This not only protects consumers but also promotes innovation and ensures fair competition. The strength of scientific evidence needed in the EU to substantiate a health claim is described as “generally accepted scientific evidence of beneficial physiological effect in humans”. The EFSA decides whether the evidence is substantiated or not.
The next question appears logically: “How is this evidence created?”
Endorsed by laws and regulations starting with the ICH-GCP, formulating the right questions and using sound scientific methods used in order to validate pertinence of a hypothetical claim by producing high quality data. Once the data have been produced and evaluated, usually by conducting a prospective, double-blind, controlled clinical study, an application to EFSA for a specific claim can be made, which will then take time to evaluate the quality and the relevance of the data produced. If the application is successful, the tested product will receive the claim and the manufacturer will have the right to have this information visible on its package. Thus, the consumers do not have to fear any more false marketing tricks, at least in the EU.
Fed up with poltergeists as well?
The MEDIACC crew can help. We like straight forward procedures and support manufactures with integrity and liability, with EU bureaucratic entanglements posing no threat to us. We are prepared! Challenge us and introduce us to your product like others on the market did.
Germany is repeatedly number 2 worldwide in the number of clinical trials initiated by industry. Well over 500 studies are initiated in Germany every year. The front-runner is Berlin, almost 50% of the studies in Germany are conducted at medical institutions. Special attention is paid to the Charité, which is one of the 5 best hospitals in the world. The majority of the studies are conducted internationally and confirm the outstanding cooperation with research partners and clinicians e.g. in China. In addition to the research landscape, Germany is also an established innovation location. In 2018, > 47,000 patents were registered. MEDIACC helps to make ideas available to patients through clinical studies by initiating studies for internationally operating partners. We are proud to do our part.
Imagine you live in the country, your child is ill and the nearest doctor is 20 kilometres away. You have an appointment for a check-up and a whining child in the child seat. Wouldn't it be ideal if your doctor could simply monitor the healing process of your child online using an app and intervene if necessary? This may not be as far away in the future as it might sound.
The new German law of the Federal Ministry of Health, "Digital Care Act (DVO)", will in future provide reimbursement of health apps by the health insurance companies. However, it is not yet clear when this will come into force.
On behalf of the German Federal Ministry of Health, the Bertelsmann Foundation is currently developing a quality criteria catalogue for the evaluation of health apps, which will serve as a quality guideline for the prescription, reimbursement and use of health apps.
This catalogue of criteria is still in progress and is not expected to be published until the end of 2019. Only then will health insurance companies have concrete criteria for the reimbursement of health apps.
Through cooperation agreements between companies and health insurance funds, individual health apps, such as the ones for tinnitus, mental health or Parkinson's disease, are already being reimbursed.
Health apps serving primarily for the prevention of a disease are already being reimbursed. These are tested by the Central Testing Laboratory for Prevention. Currently there are already 176 prevention apps, which are covered up to 100% by the health insurance companies. This number is continually increasing.
Today is the first World Patient Safety Day worldwide. In order to protect the safety and the best interests of patients in clinical studies, we implement the highest ethical standards and the appropriate regulations in all our studies. This is how we gain the trust of our customers and patients, even when conducting clinical studies with children. Recently, MEDIACC submitted a comprehensive ethical application for a study with an innovative medical device with professional athletes. By carefully choosing the endpoints and intensively training the study centres we can make sure that the study conduct will be performed according to the highest safety standards.
According to § 23b of the Medical Devices Act (MPG), there is an exception to the requirements of a clinical trial of a medical device (according to §§ 20 to 23a), as long as the corresponding medical device may carry the CE marking and a clinical study is conducted according to the intended purpose of the medical device without additional invasive or other stressful examinations. These studies can then be carried out, for example, in accordance with the medical professional code of conduct for physicians.
In such clinical studies, the product is tested according to the purpose defined by the manufacturer. In the literature, "invasive" means that an examination is carried out specifically for the purpose of the study, e.g. taking blood. Whether a clinical examination is burdensome must be weighed and assessed in each individual case on the basis of various factors and measures that have already been evaluated as such.
Clinical studies according to §23b MPG are not explicitly regulated in MDR 2017/745, which also applies to clinical studies for medical devices. In Germany, these studies will continue to be regulated under national law in the future. At present, there are no new regulations at the national level. (Information from a Notified Body in Germany, September 2019)
Such studies, which may include post-market clinical follow-up (PMCF, Annex XIV) or post-market surveillance (PMS, Article 83) under the above conditions, shall in principle be designed, planned and conducted in strict compliance with good clinical (ICH-GCP) and scientific practice, in accordance with the professional code of conduct for physicians and other applicable laws, regulations and standards.
However, "incidents" in such a study must be reported by the manufacturer, i.e. the sponsor of the study, to the authority from January 2020 on a "Manufacturer Incident Report for Serious Incidents and Incidents". This also applies to studies that have already begun.
This allows the effect, benefit, side effects and safety to be demonstrated and proven.
Since its foundation in 2013, MEDIACC has been continuously growing. During our successful work on preclinical and clinical studies, including observational studies and the reimbursement of medical apps, we were able to welcome new employees and thus slowly exceeded our old office capacity. We, furthermore, expanded our sphere of activity. As of August 26, 2019, our base is located at
– very close to our old location, right in the middle between the underground stations Berliner Straße and Güntzelstraße.
Immediately on the first day after the move, MEDIACC resumed its work. Our service for you in the new environment will not only remain at the same superior level, but will even improve from now on! Having been committed to excellence for many years, MEDIACC will continue to assist you with all questions and problems related to the ever-growing healthcare market.
We look forward to welcoming you at our new place of action!
MEDIACC is well prepared for the implemementation of the European Medical Device Regulation (MDR 2017/745) for Clinical Evaluations, Clinical Studies, Post-Market Clinical Collow-up (PMCF) and Post-Market Surveillance (PMS).
Time flies for manufacturer of medical devices and developers of medical apps. The EU MDR 2017/745 will be applicable on May 26th 2020. Transitional arrangements are put into place by the Notified Bodies. However, for medical devices requiring Clinical Studies, the MDR is binding in case last patient / last visit is not finished by this date.
MEDIACC’s employees now received the certificate on Clinical Evaluation and Clinical Studies according to EU MDR 2017/745 by Germany’s first and only designated Notified Body for EU MDR, TÜV Süd. As certified partner on the side of our clients, we make sure to striktly comply with international standards such as the Declaration of Helsinki, Good Clinical Practice (GCP) and ISO 14155:2011 as well as implement necessary changes as mandated by the new regulation to protect patients’ rights and safety and increase medical device effectiveness in the EU market.
An interesting feature in our view is that the Medical Device Regulation contains words such as “Safety”, “Clinical Data”, “Clinical Evaluation” and “Post Marketing Surveillance” are at least seven time more often than in the Medical Device Directive (MDD 93/42/EEC).
Data of 31 patients have been used in an international paediatric clinical evaluation for an innovative assistive medical device to show improved clinical outcome (94% of users) when used in addition to standard therapy. Thanks to the proficient cooperation with our university partners and clinical experts, quality of data was first-rate due to meticulous attention to details and expert knowledge. In short time, results could be published in a highly ranked free full-text peer-review journal to change therapeutic perspective for people with physical disabilities.
Our special thanks go to our patients and their families who gave their consent for their data being used – thank you!
The Berlin University Alliance, including the Charité, has won the Excellence Initiative for top university research. The German government will provide an additional 200 million Euros over the next few years to support excellent university facilities for outstanding research projects.
We congratulate all stakeholders and our cooperation partners on this great success. The funding will enable to further develop the cooperating university locations and Berlin as a top international science location.
The proof of safety and efficacy of innovative specific biopharmaceuticals according to the specifications of the Chinese National Medical Products Administration (NMPA, Chinese: 国家药品监督管理局) are subject to the requirements for clinical trials according to the regulations of the German Medicines Act and approval by the European Medicines Agency (EMA) before they can be transferred to the European market. The exact analysis of the existing work was subject of intensive and harmonious discussions before the conception of a clinical trial in Europe can begin.
We were invited to enable excellent scientific experts to start their clinical studies in Europe in 2 spin-offs from a very renowned Chinese university and supported them with the first operative project phases.
Of the new drugs coming onto the market, one in four costs more than € 100,000 per year.
The analysis of the benefit assessment according to the Drug Market Restructuring Act (AMNOG) has been in place since 2011. The fifth AMNOG Report from 2019 discusses the extent to which the high annual therapy costs of newly approved active substances can be further taken over by the insured community. In addition to data on survival chances, pharmaceutical companies are required to present high-quality data on patients‘ quality of life for all indications in order to assess the additional benefit.
This ongoing development of the benefit assessment by the authorities, G-BA and IQWiG, related to this endpoint calls for the design and conduct of clinical trials with precisely fitting and objective endpoints. This is one of our main strengths.
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