Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MDCG 2021-1 Rev.1
The objective of the guidance is to describe the harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional, anticipated for 26 May 2022. The proposed solutions aim to allow all relevant parties to meet their applicable MDR obligations whilst minimising additional burdens.
To remind you, the intended purpose of the EUDAMED modules is to: facilitate the collation and processing of information under the MDR regarding the registration of relevant economic operators, devices and systems and procedure packs (UDI), notified bodies & certificates, certain aspects of conformity assessment, clinical investigations, vigilance and market surveillance as well as post-market surveillance.
MDCG 2021-1 Rev.1 changes
Third paragraph, sentence deleted: “Parties should also note that, in principle and unless otherwise concluded by the MDCG, the reporting obligations with regard to EUDAMED apply to all information generated and collected under the MDR from its date of application (e.g. UDI, certificates) and therefore must be carried out as soon as EUDAMED becomes fully functional”
▪ Manufacturers should be well aware that the obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2021 (Art. 27(3) MDR). Labelling requirements will apply gradually, starting from 26 May 2021 (Art. 123(3)(f) MDR).
Compliance with this obligation requires manufacturers to assign, capture and store UDI information until the requisite module is capable of accepting the data.
▪ As the functionality is available in Eudamed, the system may now be used for the registration of manufacturers, authorised representatives and importers before the notice of full functionality of Eudamed has been published. Nevertheless, EU economic operators should refer to the national provisions in Member States. Readers of this guidance are requested to refer to MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.
There has been mention in various regulatory channels, of an awareness of individual member states/competent authorities requesting information above and beyond what would be required for the Eudamed database registration. And, even worse, not responding to the requisite actions, ie. confirmation of SRN numbers.
Manufacturers certainly do not need additional burdens. Why isn’t consistency the aim of the game?
▪ Manufacturers should report serious incidents and field safety corrective actions to the respective/relevant national vigilance systems. The new MIR form has been adapted to MDR requirements and should be used accordingly or manufacturers may use the current FSCA form with the additional information required under the MDR added to the general comments section of the form.
So which form will your company use?
The guidance makes reference to CircaBC as alternative solution for the relevant parties who should endeavour to make use of already existing CircaBC directories to the extent that this is possible and appropriate. https://circabc.europa.eu/faces/jsp/extension/wai/navigation/container.jsp
|Example of the types of activities and data to be collected in the alternative directories until EUDAMED is functional:|
|Nomination list of experts for joint assessment of applications||Commission|
|Monitoring and re-assessment of notified bodies||Member States|
|Inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body’s decision regarding the conformity assessment.||Notified Bodies|
|Clinical evaluation consultation procedure for certain class III and class IIb devices||Notified Bodies|
|Communicating analysis of SIs and FSCAs||Commission and Member States|
|The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authorities||Competent Authorities|
Due to the unavailability of EUDAMED, the commission, member states, notified bodies and competent authorities will be required to manage separate (confidential) directories to store and share your company data.
EUDAMED was due to become the panacea for all things related to the safety of medical devices in the European market. It is woefully inadequate (and unacceptable) that all relevant parties are subject to and are required to implement “work arounds” due to the continued delays.
Data stored and managed in various, disparate systems, is not a great start for the application of a new regulation.
Let’s hope, this time next year we will be praising the commission for a job finally done.