…as there are plenty of new, exciting and maybe even challenging topics to be discussed this year.
Above all, of course, there is the Medical Device Regulation 2017/745 / EU ("MDR"), which will be valid alone from May 2020 and will affect all manufacturers of medical devices, regardless of the risk class of their products. So far experience shows, that manufacturers have major problems with clinical evaluations and quality management systems according to EN ISO 13485.There seems to be a lot of uncertainty whether adaptation of an existing 93/42/ EEC documentation to meet MDR requirements is sufficient or new processes and related documents / evidence should be implemented and created.
The National Association of Statutory Health Insurance Funds (GKV Spitzenverband) keeps the industry busy with the updates in the List of Reimbursable Medical Devices (HMV). The impact of the new product groups, subgroups and types, as well as the updated and new requirements for the products and their documentation, is not easy to understand due to the wealth of information available. Fortunately, to date, the revision of the application forms has also resulted in, for example, information on how to design a user observation (e.g. number of patients). These requirements have not always been presented transparently in the past. At the very least, it has to be said that the List of Reimbursable medical devices will become more "dynamic" in the future, because of regular updates and the manufacturers postulated to keep an eye on this dynamic in order to respond adequately to innovations and alterations. Otherwise, they run the risk of products being deleted, perhaps ending up in a wrong category, or mistakenly not having been yet listed, even though the possibility exists.
Which brings us to the topic of reimbursement of health apps. Currently, there is no regular care or corresponding reimbursement by a payer. However, according to the Federal Ministry of Health, this is planned for 2020 and will then be attached to the BfArM (Federal Institute for Drugs and Medical Devices). Providers of health apps should therefore already aim for an approval according to MDR, implement a proof of use and register the app with the BfArM next year.
As you can see, there is a lot to discuss and perhaps a lot to clarify. We will be able to further talk about your questions and topics of interest at Rehacare. Visit us in hall 6 booth E58.