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MDR: Fulfilling EUDAMED requirements in the absence of functional system

Agnieszka Schreiber

EUDAMED, as intended by the European regulation on medical devices, will be structured around 6 interconnected modules: Actor registration, UDI and Device registration, Notified Bodies and Certificates, Clinical Investigations, Vigilance and Market Surveillance.

Publication of the regulation in 2017 assumed launch of fully functional EUDAMED system on the date of application of the MDR. In October 2019, the Commission informed that the establishment of EUDAMED is postponed and it became apparent that delivery of the system is going to be module-by-module rather than as a whole. The current state-of-play is that the different modules are becoming available on a gradual basis:

  • The Actor module was the first one available, deployed on 1 December 2020,
  • The UDI and Device and the Notified Bodies and Certificates modules are planned for September 2021,
  • The remaining modules are going to be deployed as soon as they are functional.

MDCG guidance document 2021-1 was published recently with the attempt to lay out rules on how to fulfil EUDAMED-related requirements in the absence of fully functional and interconnected system. It clarifies that the delay of EUDAMED launch does not affect the of application of the MDR and that the requirements of Article 123 continue to apply, in particular those referring to the possibility that the system is not in place as originally planned. The document also makes a reference to the transitional provisions of Article 120, stating that the alternative means of information exchange apply to legacy devices, where appropriate, with some practices continuing as per Directive requirements.

MDCG 2021-1 proposes alternative solutions for information exchange considering every obligation associated with EUDAMED. A large portion of those means refers to following the existing provisions, in most cases on national level. Some requirements point to dedicated national provisions, if such are made available. For some cases of sharing information or passing a notification, email exchange is deemed appropriate in the interim, having the information encrypted whenever possible. The Commission also plans to use CircaBC directories in certain instances of data publication and exchange. CircaBC (Communication and Information Resources Centre for Administrations, Businesses and Citizens) provides a web-based application allowing users to collaborate and manage content. EU Login account is needed to access CircaBC. The Commission is responsible for the directory and associated templates.

A clear and concise overview of all relevant requirements, their MDR references and the affected parties, along with the interim means of fulfilling these requirements, is presented below. While the alternative data exchange solutions are implemented to allow the different stakeholders to fulfil their obligations, the full accessibility of all sets of required information is going to be possible from the date when the respective EUDAMED module, or fully functional system, is available.

 

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