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The Contact Point for the healthcare industry regarding regulatory affairs

Anlaufstelle Regulatorik Gesundheitswirtschaft BW

Companies in the healthcare industry operate in a highly regulated market. Small and medium-sized enterprises (SMEs) are particularly challenged by the large number of new regulatory requirements, global competition, the shortage of qualified personnel and cost pressure. In order to support the healthcare industry in Baden-Württemberg to implement new regulatory requirements and fundamental transformation processes, BIOPRO Baden-Württemberg will be the central contact point for regulatory issues.

BIOPRO will take up the successfully established concepts that have been realized for medical technology companies as part of the MDR & IVDR Soforthilfe BW (2019 – 2021) and extend them to the entire Baden-Württemberg healthcare industry. Defined measures such as the "MDR & IVDR Expertenrunden BW", the "KlinischeStudien-Lotse BW" (only available in German) and the "MDR & IVDR Treff BW" (link only available in German) event series will be continued and completed by new measures such as the "Regulatorik Nachgefragt" (link only available in German) event series. We will also address other regulatory framework issues relevant to the healthcare industry. These include, among others:

  • the EU Regulation on Artificial Intelligence
  • the Regulation on the European Health Data Space
  • the EU Pharmaceutical Strategy
  • the Clinical Trails Regulation
  • the EU Chemicals Strategy for Sustainability (including REACH and PFAS)
  • the German Act of Financial Stabilisation of the Statutory Health Insurance System (SHI Financial Stabilisation Act)
  • ...

Important information and assistance is bundled and made available on our "Wegweiser Regulatorik Gesundheitswirtschaft BW".

Event series

The MDR & IVDR Treff BW serves the informal exchange and networking of Baden-Württembergs manufacurares of medical technology and in-vitro diagnostics on issues relating to the MDR and IVDR. It takes place at regular intervals on Fridays from 09:00 to 10:00. The events are held in English.

Event series

The event series "Regulatorik Nachgefragt" highlights current and future regulations relevant to the healthcare industry and is offered at regular intervals as an online event. The events are held in English.

Database

The KlinischeStudien-Lotse BW presents study centers in Baden-Württemberg for clinical trails with medical devices and/or in-vitro diagnostics. Detailed profile of the facilities help with the selection of a suitable trail center. (only available in German)

Website address: https://www.bio-pro.de/en/activities/anlaufstelle-regulatorik-gesundheitswirtschaft-bw