On July 1, 2020, FDA published the update of the “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking” guide that provides for the postponement to September 24, 2022 of the UDI requirements deadline for Class I and Unclassified medical devices, instead of September 24, 2020.
The UDI requirements will then enter into force four years later than originally planned.
The postponement decision is partially justified by the fact that in this period, the COVID-19 emergency situation could make difficult the preparation of the UDI requirements, to the extent that medical devices manufacturers should be given more time.
Class I and Unclassified medical devices: the deadline for UDI requirements
The two-year delay concerns the following requirements: date format, UDI labelling and the submission of data to the Global Unique Device Identification (GUDID) database.
The requirements for the affixing of UDI Direct Marking will be activated from September 24, 2022 too.
Extending the deadline for UDI requirements to September 24, 2022, FDA gives more time to Class I and Unclassified medical device manufacturers, having regard also to the complicated situation that the sector is going through due to the COVID-19 epidemic.
It should be reminded that it is not the first case of postponement with regard to Class I and Unclassified devices.
Indeed, initially FDA had established September 24, 2018 as the date of compliance for most of Class I and Unclassified devices. However, at the beginning of the 2018, due to complex political issues and technical problems, FDA decided to delay the deadline by two years.
Today, near the deadline, came the news of the new postponement to 2022.
FDA postpones to September 2022 the expiry of UDI requirements: what to do?
Two years is the right time to face in peace the adaptation to UDI requirements and it is important to organise ourselves now to plan the necessary actions.
Thema carries out support and strategic-regulatory activities for medical device manufacturers with regard to the UDI process and FDA requirements. Do not hesitate to contact us at the email address email@example.com.
Our regulatory experts are ready to support your company.