Vigilance
Adverse events and incidents.

As a medical device manufacturer and distributor, you know that medical devices must meet the requirements both in routine use as well as during a clinical trials. In Europe, this is currently done in accordance with the guidelines MDD and AIMD, which will be replaced in the future by the MDR (Medical Device Regulation, EU Regulation 2017/745). In addition, many other harmonized standards and guidance should be considered. Familiar with ISO 13485 and national requirements, in-depth knowledge of ISO 14155 etc. is required to handle (serious) unwanted events and incidents safely.

Your medical device addresses users and patients, and you have their safety in mind. Nevertheless, in clinical use residual risks can be unavoidable during diagnosis or treatment, despite a careful risk-benefit assessment. The medical device classification gives a first impression. Should something unintentional occur when using a product, adequate reporting and evaluation must be carried out. For approved medical devices, announcements must be made here; Clinical trials must promptly report and assess adverse events. In addition, the manufacturer may collect and analyse further records, in particular, adverse events may also be collected in post-market clinical studies.

(Serious) adverse events (SAE) must be reported and assessed promptly in the context of a clinical trial. Clarification should be provided in terms of severity, product relationship, use and procedure. We support you in

  • (S)AE management planning and (S)AE management
  • Support your clinical assessment of events
  • Case narratives, incl. description, reconstruction and related research
  • Preparing your reports to competent authorities and ethics committees
  • Organisation of clinical event committees (CEC meeting)
  • Selection of suitable specialists for CEC membership
  • Preparation of quarterly reports

In addition, we take over for your CE compliant products

  • Incidents and related reporting
  • Periodic Safety Update Reports (PSUR)
  • Summary of Safety and Clinical Performance (SSCP)
  • Trend analysis using your PMS, PMCF and risk management data