EU-MDR/IVDR: Reassessment of Notified Bodies Only Every 5 Years
On 8 March 2023, the European Commission published Delegated Regulations (EU) 2023/502 and 2023/503 to extend the reassessment period for notified bodies under MDR/IVDR to five years. The new time frame has already come into force.
According to the original Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), notified bodies were to be reassessed three years after their initial designation and every four years after that. The existing bottleneck and limited resources of notified bodies led to a reassessment of these timelines.
Reassessments that started before 11 March 2023 will continue unless the designating authority decides to suspend or terminate the process given its resources, the resources that the notified body has already devoted to the reassessment, and the results of the annual assessments. The Delegated Regulations will also give competent authorities the power to carry out reassessments more frequently if required.
Source:
EC: Delegated Regulation (EU) 2023/502
EC: Delegated Regulation (EU) 2023/503
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
