Author: Criterion Edge Writers
What You Need to Know
The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device (IVD) manufacturers while the EU awaits the European Database on Medical Devices (EUDAMED), a project that was scheduled to be completed years earlier than its now-projected date of Q2 2024.
Delay of EUDAMED Database
Creating the EUDAMED database, a project of the European Commission, has been an onerous and lengthy task. Originally planned to be operational by 2020, the updated completion is projected for 2024, two years after the application of the IVD Regulation (IVDR). This delay will cause a potential knowledge and practice gap for IVD stakeholders that is bridged by the publication of MDCG 2022-12.
Role of the MDCG and the New Document
Supporting the European Commission with MDR and IVDR implementation issues is the main role of the MDCG, which publishes explanatory documents such as MDCG 2022-12. Medical device manufacturers are already familiar with this type of “alternative solutions” guidance, as MDCG released a similar document in May 2021 for further clarification under MDR.
The document, which is fully entitled MDCG 2022-12 – Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR), contains an informative table that gives practice guidance and alternative solutions for IVD stakeholders to meet requirements pending the completion of EUDAMED.
| Article | Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR) | Alternative solutions to submit and/or exchange information (as required under the IVDR) | Responsible actor(s) |
| Article 36: Nomination of experts for joint assessment of applications for notification | 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise… | Paragraph 2: The Commission has made available the list to Member States by means of a dedicated secure directory in the Communication and Information Resources Centre for Administrations, Businesses and Citizens (CircaBC). | Commission (CircaBC) |
EUDAMED Functionality
Of EUDAMED’s six reporting modules, three are currently available voluntarily. They are 1) Actor Registration, 2) Notified Bodies and Certificates, and 3) Unique Device Identifiers (UDI) and Device Registration.
Once fully operational, EUDAMED there will be two reporting deadlines. Six months after its release, requirements will be mandatory for the following: Actor Registration, Vigilance, Clinical Investigation and Performance Studies, and Market Surveillance. Twenty-four months after release, requirements will be mandatory for the remaining two modules: UDI/Device Registration, and Notified Bodies and Certificates.
The Future of EUDAMED
According to Medtech Insight, “from the moment the Eudamed notice is published, “new” data must be entered. New data may relate to a new device, but may also refer to a vigilance report of any device on the market. But before any information can be entered into the database, all economic operators, devices, certificates, etc, need to be registered.”
They further elaborate, “within six months of the Eudamed notice being published, certain functionalities, including the following, will become available: registration of economic operators (MDR Article 31); registration of summary of safety and clinical performance (SSCP) (Article 32); clinical investigations applications (Articles 70-77); registration of serious incidents and field safety corrective actions; and final report of investigations (Article 87(1) and 89(5)).”
Does your organization need support for MDR related submissions including CER, CEP, PMCF plans or reports? Or IVDR related submissions like PER, PEP, SVR, CPR, or PMPF plans or reports? Criterion Edge has the expertise and bandwidth to work with you and get the job done. We have expert medical writers to support your organization in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.
