The EU regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR) came into force in May 2017 and will become fully effective on 26th May 2021 and 26th May 2022, respectively. The EU’s main objective is to ensure the safety of these products for users. This results in new requirements for the industry, which pose major challenges for micro and small companies in particular, but also for some medium-sized companies.
In summer 2019, the Ministry of Economic Affairs, Labour and Housing Baden-Württemberg made funds available for a fast-track support programme to help the medical technology sector in Baden-Württemberg implement the new regulations. The MDR & IVDR Fast-Track Support BW, which had been focused so far only on MDR, has been extended to IVD producers from 2021 onwards. The aim of the programme is to offer practical, user-oriented support services for implementing the MDR and/or IVDR by the end of 2021.
The MDR & IVDR Fast-Track Support BW programme consists of five measures to offer the medical technology companies in Baden-Württemberg practical support for implementing the MDR and IVDR, including, for example, help with preparing basic documents, information events and individual expert consultation days.
BIOPRO Baden-Württemberg GmbH is coordinating the MDR & IVDR Fast-Track Support BW.
Product Group-specific Shared DocumentsCompany consortia are developing basic documents for individual medical device groups, which can be used as a basis for creating individual certification documents. Interested companies can purchase the jointly prepared basic documents (see "Available Fast-Track Documents").
MDR & IVDR Expert Talks BWIn the expert rounds, quality management and regulatory affairs specialists as well as service providers discuss MDR- and/or IVDR-relevant issues and develop guidelines on the various topics.
Clinical Study Guide BWThe creation of a central information hub with a guide function will facilitate access to clinical trial centres and provide information on the subject.
MDR & IVDR RoundtablesThe Roundtables provide the opportunity for an informal exchange between relevant stakeholders such as notified bodies, supervisory authorities, business associations and service providers in order to minimise uncertainty in the interpretation of the new regulations.
MDR & IVDR Fast-Track Support EventsThese are events where the results and findings of the MDR Fast-track support BW programme as well as relevant topics relating to MDR and/or IVDR will be presented in the form of information sessions.