Web31 jan. 2024 · Insurance products Historically, the content of insurance products in Brazil was highly regulated and standardised. In 2024, insurance authorities passed a series or rules eliminating much of SUSEP’s intervention in this realm and seeking to foster market innovation and the creation of more tailored products. Web20 sep. 2024 · Product Liability Insurance for Medical devices. by OMC Medical Sep 20, 2024 General Information. ... These obligations are specified in Article 10 of EU MDR 2024/745, and that of Authorized representative and importer is mentioned in Articles 11 and 13, respectively.
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Web4 jun. 2024 · The MDR and IVDR introduce the requirement for medical device manufacturers to provide “sufficient financial coverage” to provide compensation for … Web12 jul. 2024 · technical information from producers. The MDR/IVDR specifically provides that injured parties can access relevant documents in the event of a possible product … lennart jansson
Medical devices: EU regulations for MDR and IVDR …
WebUltimately, following various consultations and amendments, the European Commission approved and released the text of the new regulations in 2024. While the MDR’s date of … Web24 mei 2016 · Liability insurance requirements under the new EU Medical Devices Regulation and In Vitro Diagnostics Regulation ... MDR) 8. Interface with Product … Web12 jan. 2024 · This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name … lennart kinau