The International Medical Device Regulators Forum (IMDRF) recently advanced three guidance documents intended to provide a harmonized approach to the terminology and codes used in adverse event reporting, methodologies for analyzing registry data and the clinical evaluation of software as a medical device (SaMD).
The three documents were presented to the IMDRF management committee in Forianópolis, Brazil last month, where they were cleared for public consultation by IMDRF members. While individual regulators will launch their own public consultations on the documents, as the US Food and Drug Administration (FDA) has already done for the SaMD document, comments can be submitted directly to the respective working group chairs.
All three public consultations are set to close on 2 December 2016, with the expectation that final versions will be submitted to the IMDRF management committee in February 2017.
IMDRF says the newly proposed document, Methodological Principles in the Use of International Medical Device Registry Data, tackles the latter of the two biggest issues related to device registries: linking and analyzing data from a variety of sources.
Specifically, the document seeks to address three topics:
- "International coordination in methodologies that would add value to multiple international stakeholders including regulators;
- Methodological principles in the clinical evaluation of performance/effectiveness and safety data across the device lifecycle using international Coordinated Registry Networks (iCRNs);
- Methodological principles in signal detection via iCRNs."
While many regulators see device registries, especially for implantable and other high-risk devices, as a potential source of information for everything from detecting safety issues to supporting new indications for devices, differences across registries create challenges.
"Even when data definitions and collection strategies are completely harmonized across registries, differences in device outcomes will likely persist due to both systemic and random between-country variation," IMDRF writes.
Terminologies and Codes
In the next document, IMDRF says its goal is to create harmonized terminology and coding for adverse events related to medical devices.
According to IMDRF, "widespread use of a single, appropriate adverse event terminology and coding system will improve signal detection by adverse event management systems enabling a faster response by both the industry and the regulatory agencies."
Specifically, IMDRF says a harmonized approach will provide three benefits to manufacturers, regulators, patients and healthcare providers:
- Improved accuracy of capturing and reporting medical device problems;
- Reduced ambiguity and hence increases in the effectiveness of the evaluation process; and
- It is readily usable, in contrast to narrative text, for more sophisticated approaches to signal detection (i.e. the identification of novel risks) and trending analysis by incident management systems.