Ok, so 26 May 2021 has come and gone. To date, no horsemen of the apocalypse or world annihilating meteor strike has befallen the medical device industry. However, the continued management of MDD legacy device data is an altogether different cataclysm.

According to the European Commission (EC), Legacy Devices are defined as         Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).                 It must be noted that this definition DOES NOT apply to Class I devices that are not sterile or with a measuring function as these devices did not require notified body certification.

As Class I sterile and those Class I with a measuring function are not considered legacy devices, application of a transition period does not apply and therefore immediate and complete MDR compliance is necessary for continued marketing.

Legacy devices with applicable directive certification may legally remain on the European market until:

  • The device undergoes a significant change in design or intended use thus requiring compliance to MDR legislation; or
  • 26 May 2024 provided no significant changes and the MDD/AIMDD/IVDD certificate remains valid

Legacy devices must be registered in EUDAMED if:

  • A post-market surveillance and/or a vigilance report ensues; or
  • By the end of the transition period applicable for device registration, if no equivalent MDR or IVDR device is registered in EUDAMED

Eighteen months ago, the EC issued guidance to describe how legacy devices will be identified in EUDAMED without entering the MDR obligatory Basic UDI.

An identification element EUDAMED DI (the equivalent of the Basic UDI-DI) will be required. The EUDAMED ID will be automatically and fully generated by EUDAMED from the EUDAMED DI, in case a UDI-DI is not assigned to the device. The EUDAMED ID corresponds to the UDI-DI. The EUDAMED ID is a virtual Device Identifier. It exists to keep the structure and format homogeneous for the registration of devices in EUDAMED. It is not applied on labels. The Legacy Device will therefore have the following identification elements: a EUDAMED DI (generated based on the UDI-DI) and a UDI-DI (assigned by the manufacturer). Easily understood??

For those medical device companies waiting until the last possible moment to implement an approach for MDR compliance for their 1000s of legacy devices (for example; CE certificate expiry in 2 years or no changes planned) remember you must be fully prepared for any EUDAMED post-market surveillance and/or a vigilance reporting activity. Once EUDAMED goes live, all medical device serious incidents must be captured in the database, legacy or MDR certified.

Regulatory affairs teams, and those responsible for EUDAMED data transmission, will need to be included in the post-market surveillance team process to guarantee that the applicable data is collected and transmitted within the appropriate timeframes. Failure transmit the data in a timely manner risks non-compliance.

The date of application has passed. The medical device industry did not spontaneously implode. However, do not become complacent when executing the mandatory, on-going and resource intensive activities essential to keep life enhancing products on the European market.

Supporting your regulatory affairs teams by providing the appropriate data capture tools before MDR compliance crunch time, will ensure greater a efficiency, increase in consistency and a significant reduction in human errors.

More to come…

KimYoung@instem.com

K Young

References:

https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices-

https://ec.europa.eu/docsroom/documents/34921