IMDRF Adverse Event Reporting Codes
The International Medical Device Regulators Forum (IMDRF) have published a document entitled IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes. The purpose of this document is to aid in harmonization of adverse event reporting by use of codes that have been generated. They aim to facilitate the adverse event reporting ...
Post-Market Clinical Follow-up (PMCF)
Post-Market Clinical Follow-up is steadily becoming a main element of conformity with the EU MDR. Post-Market Clinical Follow-up (PMCF) is not an entirely new concept. It was originally introduced in the EU Medical Device Directive 93/42/EEC (MDD) with guidance on this requirement provided through MEDDEV 2.12/2 rev.2. The EU MDR builds on this concept further, ...
