EUDAMED Delay and Consequence - Implications for ABHI Members
EUDAMED Delay and Consequence
Introduction
It has been announced that the EUDAMED Database, an integral part of the Medical Device and In-Vitro Diagnostics Regulations, will be delayed in its launch from 27th May 2020, to 27th May 2022. The Medical Device Regulation had described specifically how the Commission would ‘seek’ to have the database up and running by the 2020 deadline.
This delay, therefore, adds to the already strained transition to the new regulation.
The Database
EUDAMED is the name given to the future European Database, described in Articles 33 and 30 of the MDR and IVDR respectively, which has the intention of;
- Informing the public as to products placed on the EU market
- Listing certificates issued by Notified Bodies
- Holding UDI information for traceability purposes
- Providing the public with appropriate clinical investigation information
- Providing the public with appropriate vigilance information
- Enabling transparency in Competent Authority and Commission communications
- Holding registration information on ‘Economic Operators’
- Listing the results of Post Market Surveillance activities undertaken by manufacturers.
The database, therefore, is a critical part of the MDR/IVDR with respect to transparency and communications with the public, addressing criticisms of industry, such as clinical performance, follow-up and risk management. Eudamed, as a solution, was also discussed as part of evidence submissions to the Cumberlege Review of Medicines and Medical Devices Safety.
Implications for MDR/IVDR Transposition
The most significant implications are for the MDR, as this is one of the cornerstones of ensuring greater pan-European transparency, increased safety vigilance, traceability and public access to data. The impact on the IVDR is less, as the new roll-out date for EUDAMED coincides with the end of the IVDR transition.
It is important to note, however, that the forms that are to be used to input vigilance data into EUDAMED (the MIR forms), have just been updated and will be rolled out across Europe in January 2020.
The delay, however, is unlikely to prevent any other of the MDR/IVDR functionality coming on-line before May, 2020.
The delay may also increase the proliferation of other national databases across Europe, so the advantages highlighted above may be negligible. The development of these national databases needs to be monitored, as there may be additional charges for companies.
Effect on UDI Application
The use of UDI as part of product labelling and traceability, is largely unaffected. UDI is to be an important part of the data inputted into EUDAMED, for both traceability and identification purposes, but will be used irrespective of the EUDAMED application date. Manufacturers are recommended to continue in their efforts to incorporate the requirements for UDI as part of MDR transition.
BREXIT Overlays
There are already plans in place to bolster the UK’s National registration database in light of our EU exit. However, our involvement with EUDAMED may yet be approved as a result of a ‘deal’. The National database will require ALL products to be registered with the MHRA prior to being placed on the market, and is coming at a price. Each submission onto the UK database will cost around £100, although individual submissions can be for multiple products of the same ‘code’, i.e. a number of disposables used for the same product, or implants of the same design but different sizes.
The public accessibility and functionality of the UK national database have yet to be determined, although it is unlikely to be as complete as those anticipated in EUDAMED.
Importantly, some ABHI members have expressed difficulties in interacting with the new UK database, which has been described by the MHRA as having “teething problems.”
The registration database being envisaged by the MHRA could be rolled-out ahead of EUDAMED, which may be an advantage, increasing confidence in the UK HealthTech industry (in the same way that EUDAMED is supposed to do throughout Europe).
As the precise nature of Brexit is yet to be determined, there have, to date, been no discussions on the UK’s input into EUDAMED. However, ABHI has argued for this continued involvement, particularly in the vigilance ‘modules.’ We, recommend this in many of our conversations with MHRA, OLS and other stakeholders, believing that the UK’s involvement will protect the integrity of European-wide vigilance systems.
