The GHTF is ending and will be replaced by a regulator-only organization, the International Medical Device Regulators Forum (IMDRF). This is the closing statement by the GHTF: GHTF-Closing-Statement.
FDA: Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices
Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803. Read more: https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices