What is EUDAMED?
Eudamed is the European Databank on Medical Devices. It’s a protected, web-based gateway that serves as a central store for the exchange of important information for national competent authorities to communicate with the European Commission. This old EUDAMED portal is not accessible by the public at the moment. EUDAMED came into force in May 2011 and was created with the purpose of reinforcement of market surveillance and transparency for medical devices put on the European market.
What is the UDI?
The UDI is a series of numeric or alphanumeric characters that is made through a globally acknowledged device identification and coding mechanism. It permits the transparent identification of a unique medical device on the market. The UDI is made up of the UDI-DI and UDI-PI. The unique identifier may incorporate information on the lot or serial number and is capable to be implemented everywhere.
The artifact of a UDI comprises of the following:
- A UDI device identifier (‘UDI-DI’) relevant to a device, offering access to the information implemented in Part B of Annex VI.
- A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as stated in Annex VI Part C.
What will be EUDAMED under new EU MDR?
The new EU MDR Regulations contains important improvements comprising of a much larger EUDAMED database than the one that presently exists under the Medical Devices Directives. EUDAMED 2 is the IT system developed by the European Commission to implement under the new regulations i.e. Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
How does Eudamed achieve transparency and market surveillance?
Eudamed is offering national competent authorities with quick, easy access to appropriate regulatory information. It also empowers with the application of a uniform approach to the Medical Device Directives.
What information is stored in EUDAMED?
It depends on the product classification and relevant sections under the old medical device Directive. Eudamed comprises of the following information:
- The registration of medical devices on EU marker, manufacturers, Authorized Representatives
- Declaration of conformity
- A vigilance and traceability system (EU Declaration or statement on ISO certificate)
- Labeling and instructions (Representation in English)
- Rationalization of the classification as per Annex IX
- A copy of ISO 13485 certificate or Evidence of a QMS
- Reports on Clinical Investigations
- Additional documentations may be needed, reliant on the particular characteristics of the device.
All data acquired for EUDAMED is offered as per the Medical Device Vigilance System. The efficiency and value of EUDAMED has been the matter of firm evaluation, the outcomes of which are accessible to the public; however, it is anticipated to be expanded and enhanced under the NEW Medical Device Regulation.
What’s the role of the Global Medical Device Nomenclature?
The Global Medical Device Nomenclature (GMDN) is an important instrument for EUDAMED and advancement towards synchronization of the EU Member States. GMDN is a central reference of general accounts of medical device which is internationally agreed. GMDN is utilized to recognize medical devices. Each medical device has a GMDN code related to it at the Notification point within EUDAMED. This system permits global operators to recognize medical devices and interchange information concerning to performance and safety of the device. It is the outcome of the collaborative work of medical device professionals from all over the world and directed by the European Commission. The GMDN also offers best practice for manufacturers utilizing EUDAMED.
What is the Basic UDI-DI?
The Basic UDI-DI is the primary admittance key for device-associated information in the EUDAMED database and it is stated in pertinent documentation.
Basic UDI-DI vs GS1
Global Model Number (GMN), or Basic UDI-DI under the EU Medical Device Regulation
A product model is a base product design or specification from which a trade item is derived. The trade item inherits major features/functions from the base model. The GS1 Global Model Number (GMN) is the GS1 identification key used to identify product models from which trade items are derived. The GMN comprises the GS1 Company Prefix and a model reference. The model reference is alphanumeric and its structure is left to the discretion of the brand owner who assigns it. The GMN is an up-to-25 length character key (23 characters plus 2 check digits). This element string, once assigned to one product model, SHALL NOT be reissued to another. The GMN SHALL NOT be used to identify a trade item. The manufacturer assigns the GMN (check this guide).
Which documents contain the Basic UDI-DI references?
Examples are documents (incorporating certificate of free sale), declaration of conformity for market, clinical performance, safety summary data and technical documentation. It is envisioned to identify and connected devices with the same proposed objective, risk class and important design and manufacturing particulars.
Does the Labeling, Packaging or Trade Item already contain Basic UDI-DI?
The Basic UDI-DI it is an additional requirement which is independent from the existing packaging and labeling of the device. Also it does not appear in any existing trade item.
Is there any Guidance available on Basic-UDI?
MDCG 2018-1 v3 guidance offers additional information on Basic UDI-DI.
Which products are subject to the UDI system?
The UDI system should be implemented to all devices, except some custom-made and performance study or investigational devices.
Who is responsible for placing the UDI carrier on the device itself, on the label and on the package of a device?
The manufacturer is liable for conforming to all EU UDI related requirements. This comprises the assignment of the UDI registration in the EUDAMED database and the employment of the UDI carrier on the label of the medical device or on its packaging, also for reusable devices, or on the device itself.
What is the target date for a device to conform to the UDI requirements?
The implementation target date for UDI is similar to the date of enforcement of the two new Regulations; such as 26 May 2022 for In Vitro diagnostic medical devices and 26 May 2021 for medical devices.
Alysidia is providing tools and resources to deal with EUDAMED and UDI. And the amazing news here is that all this is offered within a single roof. Should you have any more questions, Alysidia will be happy to assist you.
