"In his recent paper, “Basic Anatomy of a Design Dossier,” Dr. Hamish Forster, orthopedic and dental product expert for BSI Healthcare, provides an overview of the key elements required within technical documentation to demonstrate conformity to the Medical Device Directive 93/42/EEC.
One such component is the requirements for a post-market surveillance (PMS) report. As stated by Forster, “Post-market surveillance data may be provided for devices already marketed in the EEA and/or other geographical territories.
A postmarket surveillance plan should also be provided specific to the device under review. A post-market clinical follow up (PMCF) study is expected as part of this plan.
The elements of the post-market surveillance plan can be provided within the executive summary along with a brief description of the PMCF study. There should be an adequate rationale if a PMCF study is deemed unnecessary.”
He continues, “It is recommended to detail how often key documentation used to demonstrate conformity to the Essential Requirements will be updated in response to information gained during post-market surveillance.”
Following the publication of Forster’s paper, revisions to the guidance documents regarding PMCF were made, and, as the recent revisions represent a larger shift in the medical device manufacturing community, it is beneficial to expand on his overview of post-market clinical planning and data as a critical part of the design dossier and/or technical documentation of a device."