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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