The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up
In my previous BONEZONE article, “Basic Anatomy of a Design Dossier” (BONEZONE March 2011), I presented an overview of the key elements required within technical documentation in order to demonstrate conformity to the Medical Device Directive (MDD) 93/42/EEC.
A key requirement is post-market surveillance data. As stated in the earlier article, “Post-market surveillance data may be provided for devices already marketed in the EEA and/or other geographical territories. A post-market 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. 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 that article, revisions to the guidance document 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 this critical part of the MDD requirements.
Overview of Guidance Document Scope and Revisions
The revisions to the PMCF guidance document (MEDDEV 2.12-2, REV. 2) are reflective of an emphasis on long-term clinical data, articulating the importance of the details and documentation required for post-market clinical studies as a part of an appropriate PMCF plan. The new document is in accordance with the Global Harmonization Task Force (GHTF) and was driven by initiatives of EU legislation. The document provides guidelines and support for the creation of risk-based PMS plans in accordance with existing guidance documents and ISO standards relevant to clinical data plans, analysis and final reporting. It also provides details on the role of Notified Bodies in PMCF.
With a more comprehensive understanding of these revisions, manufacturers can work more efficiently and seamlessly with Notified Bodies in the review/audit process and plan and execute the PMCF plan, as well as overall post-market surveillance.
It is important to note that PMCF plans (and the guidelines that inform them) are not only relevant for high-risk devices, but may also apply to a device of any class that is affected by defined parameters that contribute to residual risk – which is the primary type of risk addressed in the post-market phase. Residual risk is what remains after risk control measures have been taken (i.e., during the pre-market phase), including known, emerging or potential risks due to statistical limitations.2 MEDDEV 2.12-2,REV.2 outlines specific circumstances that contribute to residual risk.