EUDAMED: Management of legacy devices
On 15 February 2021, the European Commission published a 13-page document on the management of legacy devices. It clarifies questions on how these will be identified in EUDAMED or how the different Unique Device Identifiers (UDI) will be generated or assigned.
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).”
Thus, the products are already on the market but still have to be registered once the new MDR/IVDR apply. An EUDAMED DI (primary identifier) and an EUDAMED ID (device identifier) will be required. Detailed information on this process can be found in MDCG 2019-5 Registration of legacy devices in EUDAMED published in 2019. The management guide itself offers consise flowcharts and case studies.
Sources:
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:
