It has been known since 20017 and yet there is still a lot that needs to be clarified regarding the EU Medical Device Regulation (MDR). Both manufacturers and distributors were able to take a deep breath, as the implementation period was postponed by one year to May 26, 2021 due to Corona. "As a result, the medical technology companies have been given another grace period, but we still perceive a great deal of uncertainty in the market," says André Hofmann, Managing Director of biosaxony. "At the same time, the number of notified bodies that are allowed to certify according to the new MDR is growing, and some manufacturers have already been able to gain initial experience in implementing the new requirements." Against this background, the Saxon cluster wants to help inform as many players in the industry as possible about the necessary requirements and challenges. André Hofmann: "As a trade association, we would like to enable an exchange of experiences in order to reduce uncertainties and encourage manufacturers and distributors in their actions."
How does a DiGA get through the approval process?
But the need for information is not limited to the EU-MDR. With the Digital Care Act (DVG), which was introduced by the federal government this year, there is now a reimbursement method for digital health applications (DiGA) through the statutory health insurance for the first time. Whether anxiety disorders, obesity, sleep disorders - for the first time there is now an app on prescription for all these diseases. The first have already been approved by the Federal Institute for Drugs and Medical Devices (BfArM), but there are still question marks for many providers. "The DiGAV and manufacturer guidelines are silent on many formal and content-related requirements for the proof of benefit of a DiGA," says Martin Blaschka from the WIG2 Institute and adds: “What the BfArM tacitly assumes to be good scientific practice, for example, is often unknown to young manufacturers in particular. Initial practical experience shows that there are numerous pitfalls lurking here.” According to experts, there are also uncertainties with regard to the major topic of data security and cybersecurity Johannes Endres from Althammer & Kill GmbH & Co. KG to report: "Many DiGA providers apparently perceive the numerous specifications on data protection and information security as an overwhelming jungle that blocks the view of the consequences of these specifications in practice and how they are to be implemented technically".
MDR and DVG - compact information in a free online conference
This provides answers to many of these questions two-day online event “Quo vadis, MDR and DVG”, which was developed jointly by biosaxony and the WIG2 Institute am 16th and 17th December organized will. From 13 p.m. to 16 p.m. there are specialist lectures on different perspectives on the respective topic. The first day is dedicated to the EU-MDR, the second to the DVG. The event is sponsored by the Office for Economic Development of the City of Leipzig, so participation is free of charge, but the total number of listeners is limited.
Those interested can register here: https://www.biosaxony.com/veranstaltungen/quo-vadis-mdr-und-dvg-bestehende-herausforderungen-und-erste-best-practices
Source: Report on medtech-zwo.de from December 03.12.2020rd, XNUMX