IMDRF Recommends Principles for Using Global Device Registries, Qualifications for Reviewers

The International Medical Device Regulators Forum is seeking global coordination of medical device registries, and has recommended principles for evaluating data in a final document released following its March meeting in Vancouver.

By coordinating internationally on methodologies for collecting and evaluating clinical data, international stakeholders can begin to develop a minimum core dataset for evaluating device product life cycles to detect signals earlier. That is seen as a step toward establishing a National Evaluation System for health technology, which is one of the FDA’s top priorities.

Under the IMDRF plan, international registry networks would agree on pre-specified analyses and collaborative sharing of outputs with each other and the regulators. A standing IMDRF registry working group would facilitate this and would focus on higher-risk implantable devices.

The registry working group notes that variations between countries would make pooling data tricky, but that by starting with the minimum necessary data for analysis, metrics could be applied based on similarities and differences. In addition, more could be learned about clinical variability across different populations, and from that data more objective performance criteria could be created.

IMDRF says registries could be used to apply comparative effectiveness data as well as root cause analyses. It calls for international methodology pilots to work out the practicalities of sharing international data.

Registries are an ideal infrastructure for initiating clinical trials, and regulators should reach consensus on an international set of principles for deciding when a randomized clinical trial should be required, the group says.

Another IMFDRF working group focused on good regulatory review practices. It provided recommendations for conduct, education, experience, and training for conformity assessment reviewers, whether conducted by regulatory authorities or Conformity Assessment Bodies (CABs). A common set of values would develop confidence in the consistency of reviews.

The working group stressed the importance of ensuring confidentiality of “professional secrecy” by regulatory reviewers in sharing information obtained in carrying out their tasks and it has developed a code of conduct for reviewers.

Read the IMDRF documents here: www.fdanews.com/04-05-17-IMDRFregistries.pdf and www.fdanews.com/04-05-17-IMDRFRegulatoryreviews.pdf.