In this week’s roundup: Large notified body TÜV SÜD advertises “structured dialogue” advisory services for MDR/IVDR; FDA posts latest revision to a draft guidance on scientific communication about off-label indications; the EU discloses more delays for the EUDAMED database; CPT panel outcomes; digital health picks; MedPAC plans; and much more from Europe, the US, Mexico, and Asia.
EU structured dialogues, new FDA off-label guide:
Chat with TÜV SÜD? This week, the large notified body TÜV SÜD announced its new “structured dialogue” service for companies seeking certification under the EU Medical Device and IVD Regulations. “The purpose of a structured dialogue prior to lodging a formal MDR or IVDR application with TÜV SÜD Product Service GmbH is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents,” the assessment organization stated in an October 23 marketing email. Device firms have consistently complained about surprise documentation requests and unexpected delays from notified bodies during official MDR or IVDR conformity assessment reviews, and have asked for informal input from the bodies prior to applying for a CE mark to improve predictability. Strict EU prohibitions against notified bodies engaging in consulting activities have largely blocked those types of interactions, but TÜV SÜD appears to have designed an approach it believes is compliant. The structured dialogues are “independent of the assessment,” the notified body stresses. “Therefore, and to show the utmost intention of being independent, impartial, and objective, the structured dialogue service shall be ordered independently from the MDR/IVDR framework agreement.” Just last week, the notified body subgroup of the EU Medical Device Coordination Group (MDCG) discussed questions around setting up structured dialogues.