By Amanda Maxwell, European Regulatory Affairs Editor, Medtech Insight
Lack of an official explanation about how the exchange of critical information will progress pending the launch of the EU’s medical device database, EUDAMED 3, has left many confused. New guidance lights the way forward.
Clarification about how the various actors, manufacturers, notified bodies and competent authorities should exchange information in the context of the Medical Device Regulation, pending the official launch of the new version of the EUDAMED database, is now available. The Medical Device Coordination Group (MDCG) has endorsed a 31-page guidance on harmonized administrative practices and alternative technical solutions (MDCG 2021-1).
The guidance explains how the medtech sector can best comply with exchange MDR-related information in the areas of device registration, clinical investigation and vigilance, for example, in the absence of the full EUDAMED database. And it elucidates how information that was due to be made available to lay people can still be released before the updated EUDAMED full launch date.
While the premise is that until the new version of EUDAMED is fully functional, the requirements of the current medical device directives will continue to apply, it is not that straightforward. The purpose of this guidance, therefore, is to address, in particular, cases where the exchange of information would be difficult, or even not possible, based on the corresponding provisions of the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD).
The 28-page table in the document clearly notes which actors are responsible for what type of information exchange in each relevant article of the MDR, and it spells out the provisions related to the use of EUDAMED (as referred to in Article 123(3)(d) MDR) as well as the alternative solutions.
There has been progress, however, and continues to be. Since 1 December 2020, manufacturers and other economic operators have been able to register as actors, on a voluntary basis, in the database. Voluntary registration of devices starts from late May.
Richard Houlihan, CEO of Eudamed.eu consultancy, which advises on EUDAMED matters, told Medtech Insight that companies will be able to add their devices after the device module goes live.
But until the official notice is published signifying the EUDAMED launch date they must continue to follow the registration guidelines as they do with the current medical device directives with their national authorities.
While compliance remains voluntary, he said, companies should add their devices as soon as possible if companies want commission support. This is because, he said, “when IT systems are newly launched IT teams have a chance to help; but by 2022 the IT teams will be busy on other parts of the system.”
EUDAMED provides the framework to enable the much-demanded transparency in the new regulatory system. It cannot fully apply until all six inter-related modules are ready.
It was originally foreseen that it would be up and running May 2020. But now, it is not due to be officially launched until 26 May 2022, the date of the full application of the IVD Regulation, and exactly one year after the delayed MDR fully applies.
Even after launch, there is a transition period allowing actors in the sector another six months after publication of the notice in the Official Journal of the EU declaring the database fully functional until they need to fully comply. (Requirements set out in MDR Articles 29(4) relating to the registration of devices, and Article 56(5) relating to notified body certificates will fully apply 24 months after the notice.)
In the meantime, and to assist companies in already becoming compliant as far as possible with the new database, parts of EUDAMED are being launched on a voluntary basis. Until EUDAMED is fully functional and the official notice has been published the use of these parts EUDAMED remains voluntary.
There are many references in MDCG 2021-1 to making information available through CircaBC, the European Commission’s collaborative platform that offers easy distribution and management of documents for many different sectors, until the EUDAMED database is officially launched. Circa BC stands for the Communication and Information Resource Centre for Administrations, Businesses and Citizens.
Houlihan, who is particularly well placed to comment on these matters having worked as EUDAMED IT technical management consultant at the European Commission from 2011 until 2019, told Medtech Insight that, in the filed of medical devices, CircaBC is normally used for working groups and internal EC/member state communications.
It is not a searchable database “but as an interim solution, it is already existing and can be delivered fast, so is a good solution,” he said.
CircaBC is mentioned in several places concerning notified bodies and certificates as well as in relation to clinical investigations.
When it comes to clinical investigations, both sponsors and member states will use secure folders in CircaBC for the reports and certificates, for example.
Moreover, mirroring the MDR’s requirement for making summary reports of clinical investigations available to the public, the guidance says that these should be published via the use of a dedicated, publicly accessible folder in the CircaBC directory and that the publication process should be coordinated by the MDCG to avoid duplications.
The six different EUDAMED electronic systems, called ‘modules’, which facilitate the collation and processing of information under the MDR and IVDR and which all need to be ready before EUDAMED can be officially launched, are for:
The registration of relevant economic operators (actor registration) – this is already active on a voluntary basis.
At its meeting on 12 March 2020, the MDCG agreed that the commission should make each EUDAMED module available to member states as soon as it is operational. This approach also has an impact on the means by which relevant information collected under the MDR will be made available to the public, which will take place on a gradual basis.
There is a significant omission in the document, however, Houlihan noted; the commission does not address is what happens to all the data and documents the competent authorities and notified bodies upload to the secure CircaBC folders once EUDAMED is ready.
“They do not mention if everyone will have to upload the same information to EUDAMED once it becomes fully functional,” he said.
This is also the case for the MDR vigilance cases that occur between 26 May 2021 and 26 May 2022. While manufacturers must report these as they did under the directives to the national authorities, it is uncertain, he said, whether they will be required to duplicate reporting by having to add them to EUDAMED after 2022.
The document does say, however, 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 and therefore must be carried out as soon as EUDAMED becomes fully functional.” Some further explanation of this wording would be useful.
Additional requirements introduced as part of the alternative measures and highlighted by Houlihan include the following:
It is also worth noting that the commission document is prefaced by a paragraph stating that it is “not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law,”
