On February 19th, 2019, Kalms Consulting led the expert forum “How to implement IVDR successfully – case studies and practical questions” as part of the event “Meeting MDR / IVDR challenges together”.
The event was conducted under the leadership of the cluster Health Capital Berlin and Brandenburg with the partner Spectaris German Industrial Association for Optical, Medical and Mechatronic Technologies e.V. (Spectaris e.V.) and Network Diagnostics Berlin-Brandenburg (DiagnostikNet-BB e.V.).
As part of the event, the initiated discussion with Lowri Evans and Günther Öttinger was presented as an interchange to the European Commission and the current implications of MDR and the IVDR on manufacturers in Germany was discussed.
Dr. Sinan Akdeniz, representative of Unit 124 – Medical Device Safety, provided in-depth insights into the background work of the responsible working groups in the Federal Ministry of Health.
With the words of welcome from Health Minister Susanna Karawanskij from the Ministry of Labour, Social Affairs, Health, Women and Family of the State of Brandenburg on the funding measure “Klinische Evidenz belegen – Medizintechnik in die Patientenversorgung überführen ” of the BMBF was presented by the project sponsor VDI Technologiezentrum GmbH. Subsequently our consultants. Dr. Julia Knorr, Dr. Madeleine Künz and partner Dr. Maren von Fritschen successfully guided 26 participants through a five-hour workshop, where they excitedly discussed relevant challenges, progress, as well as legal innovations and regulatory uncertainties.
The extensive exchange revealed numerous new challenges as well as ambiguities in the dynamic IVDR sector, which are now being used in the hands of the partners for the preparation of a standpoint paper in order to further exchange and discourse with the European representatives.
Kalms Consulting is pleased to assist you and your company with our various expert teams as a strong partner for successful and seamless market access – feel free to contact us.Published on: May 19, 2019