Publication & submission of Clinical Investigation Reports (CIRs) — MDCG guidance & Article 77(5) reminders
Reinforced obligations to publish clinical investigation reports and to submit the CIR to Member States within timelines (generally 1 year after end of CI; 3 months after early termination/halt), and guidance on summaries for public disclosure while EUDAMED is still transitioning.
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Reghelps SRC
Founded in 2015, we are fully committed to providing legal and regulatory compliance consulting and documentation services, with a strong focus on data security in alignment with ISO 17001 and ISO 13485 standards.
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