Post-Market Clinical Follow-up Studies with Additional Invasive and/or Burdensome Procedures

Applications for PMCF studies which include an additional invasive and/or burdensome procedure must be completed using the NREC-MD PMCF Additional Invasive/Burdensome Procedure Investigation Form.

Requirements

  • Proposed additional invasive/burdensome procedure(s) should be clearly described in the NREC form.
  • All changes to documentation should be clearly marked up on each document in question.
  • Evidence of fee payment should be submitted with each submission.

Additional Invasive/Burdensome Procedure within PMCF studies originally approved by local REC

Applicants should submit the NREC-MD PMCF Additional Invasive/Burdensome Procedure Investigation Form, all documentation (and any other relevant study updates) submitted to the original approving ethics committee, and evidence of fee payment to the National Office for consideration of the application.

To note

  • It is the responsibility of the Principal Investigator or Sponsor to determine whether an additional procedure within the PMCF investigation is ‘invasive’ or ‘burdensome’.
  • PMCF investigations which include an additional invasive or burdensome procedure must be reviewed and approved by the relevant NREC prior to any study being actioned.
  • Applicants must pay the appropriate fee in advance of submitting their application. Find more out about NREC fees.
  • See our Operational Framework for more details on the review process of PMCF investigations with additional invasive and/or burdensome procedures.

Applications should be submitted (in a zipped folder) to devices@nrec.ie.

Queries relating to such PMCF investigations can be addressed by the National Office team at devices@nrec.ie for Clinical Investigations of Medical Devices (NREC-MD).

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