Post-Market Clinical Follow-up / Post-Market Performance Studies with Additional Invasive and/or Burdensome Procedures
Applications for post-market clinical follow up of medical devices/ post-market performance follow up of in vitro medical devices (PMCF/ PMPF) studies which include an additional invasive and/or burdensome procedure must in addition to the NREC-MD application form also include a completed NREC-MD PMCF/PMPF Additional Invasive/Burdensome Procedure Investigation Form.
- 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.
- It is the responsibility of the Principal Investigator or Sponsor to determine whether an additional procedure within the PMCF/ PMPF investigation is ‘invasive’ or ‘burdensome’.
- PMCF/PMPF 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/PMPF investigations with additional invasive and/or burdensome procedures.
Applications should be submitted (in a zipped folder) to email@example.com.
Queries relating to such PMCF/ PMPF investigations can be addressed by the National Office team at firstname.lastname@example.org.