Lessons learned from the pandemic – from the perspective of regulators & innovators
Requalite team continues to be engaged in educational activities in order to better facilitate the medical device conformity process by providing an extensive portfolio of services for healthcare companies. To help the clients in managing their audits and submissions with the notified bodies and competent authorities in accordance with European regulations, Requalite regularly holds meetings, seminars, workshops and panels.
One of the recent panels were held on April 26, 2023 in Requalite’s new headquarter office located at Gräfelfing-Munich. The panel hosted important experts in the field. Requalite Managing Director Dr. Hakan Inan, Dr Rainer Metzger from Medicover and Dr. Jochen M. Wettengel from Institute of Virology, TUM shared their insights on the latest regulations, developments and advancements in the sector. In particular, the impact of COVID pandemics on the manufacturers, clinics, hospitals, and service companies have been discussed in details. An important take home message by all the experts is that Diagnostic and Medical Device industry is on the frontline in fight against current and future potential diseases. The panel has been quite insightful as the expert speakers provided technical and scientific knowledge in developing safer and better performing medical devices in accordance with EU regulations which aim to improve patients’ life.
A few important excerpts from the panel discussion:
Dr Rainer Metzger- Medicover : IVDR has a broader impact on various segments of the industry. For instance, conducting of clinical trials requiring kits, assays, ant devices which needs to bear CE as per IVDR is greatly effected by the availability of the compliant and certified devices.
Dr Hakan Inan, Requalite: For sure, IVDR is significantly impacting all companies whether small or big scale and it has a short term effect including financial, innovation, and competition aspects. However, by helping companies to bring better performing and safer devices IVDR will carry long term value for end users and companies over non-CE marked devices.
Dr Jochen Wettengel, TUM Virology: The current pandemic has significantly helped the hospital and clinical laboratories to update their infrastructure, renew the device inventories, and securing faster and better performing tests and assays for disease management.