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Materiovigilance

We offer consultancy concerning medical device safety monitoring (MDR) as stipulated by applicable EU legislation and national laws and regulations, which must be introduced in practice as the transition period is approaching its end. We shall perform a comprehensive analysis of your specific obligations and how to implement them. We are the experts, leave your troubles to us!

Service portfolio

  • Local monitoring of medical devices in medical and scientific journals (MLM) in accordance with applicable legislation including MDR in nearly all European countries
  • Global monitoring of medical devices in international databases
  • Retrospective analyses and monitoring of international and local medical journals
  • Single literature searches focusing on a specific topic
  • Consultancy in MDR/IVDR (Medical Devices Regulation / In-vitro Diagnostics Regulation)
  • Assistance in the preparation of the Periodic Safety Update Report (PSUR) for medical devices as stipulated by the MDR (MD class IIa: once every 2 years or more frequently, MD classes IIb and III: once a year or more frequently)
  • Assistance in the preparation of basic documents for the European Database on Medical Devices (EUDAMED)
  • Assistance in the preparation of documents required by the Notified Body and serving to demonstrate conformity
  • Description of the state of the art
  • (Assistance in the) preparation or check of the PMS, PMCF according to Regulation 2017/745/EU
  • (Assistance in the) preparation or check of the risk management measures as stipulated by ČSN EN ISO 14971:2019
  • (Assistance in the) preparation of documents for assessment/equivalence aspect
  • Language translations of papers and legislative information, comments, etc.

Legislative basis

  • Regulation (EU) 2017/745 on medical devices
  • Regulation (EU) 2017/746 on in vitro diagnostic medical devices
  • Czech Acts No. 89/2021 Coll. and No. 90/2021 Coll., on medical devices and on in vitro diagnostic medical devices
  • Regulation No. 186/2021 Coll., on the implementation of certain clauses of the Act on Medical Devices
  • Regulation No. 187/2021 Coll., amending Regulation No 62/2015 Coll., on the implementation of certain clauses of the Act on Medical Devices