Medical Devices have been under the spotlight for some time now. With its’ regulation being chopped and changed, many manufacturers have had to undergo reclassification of their devices in order to meet new regulatory requirements. Along with new regulation came the introduction of new terms such as EUDAMED and UDI. These have caused quite the confusion, so below we’ll be clarifying what they mean for your business.
First, a RECAP:
Medical Devices were previously governed under Medical Device Directive MDD (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC). These three Directives have merged into two, and are now being replaced by the new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), subject to a 3 and 5 year transition period respectively.
The MDR will take effect on the 26th of May 2020 and IVDR 2 years later. Medical Devices with pre-existing CE-marks may have more time to make the necessary changes as they remain valid when these new Regulations take effect for up to a period of 4 years, until the May 2024 backstop kicks in, where all products must comply. However, as per article 120, Section 3, three MDR requirements must be met by the 26th of May 2020 for all medical devices: post-market surveillance, vigilance and registration of economic operators. It is also worth noting that Class 1 medical devices not subject to Corrigendum 2 are expected to comply with all MDR requirements by the 26th of May 2020.
New Medical Device Regulations will mean stricter requirements in relation to clinical evaluations, post market surveillance and vigilance, as well as changes to medical device classifications with some being classified to higher devices and the need for a Responsible Person for regulatory compliance. In addition, the regulation introduced the establishment of an EU database on medical devices (EUDAMED) and Unique Device Identification numbers for device traceability.
Although the EUDAMED database was set to go live in March 2020, it has now been postponed to May 2022. The EUDAMED database aims to assist European authorities with the exchange of information on medical devices. It’s use will be restricted to national competent authorities only and whilst it will disseminate some information to the general public, it won’t be fully accessible to them. It will primarily act as a registration and notification system and will contain information on UDI’s vigilance, market surveillance and clinical investigations. Whilst as a consequence of the EUDAMED delay some rules related to its’ application are postponed, the delay of the database does not prevent the application of the new Regulations.
The Medical Device Co-ordination Group (MDCG) advise that while EUDAMED is a requirement for MDR certification, they are working on a harmonised administrative solution to facilitate the exchange of information in its absence. Currently, the relevant obligations under the new MDR are to be abided by in accordance with the provisions and means under the current Medical Device Directives (MDD). A guidance document is currently being prepared but to put it simply, manufacturers need to comply with MDR using MDD pathways. The following guidance document is applicable to the UK: https://ec.europa.eu/docsroom/documents/40286
The EUDAMED database requires products to have a Unique Device Identification number. This number is specific to each device and is required for product identification, traceability and tracking through the database.
What is a UDI?
A UDI is defined as a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. To put it simply, it’s a couple of numbers and letters that now need to placed on your device.
What is a UDI made up of?
A UDI is made up of a couple of components:
A Basic UDI-DI is like the main key for accessing device-related information in the EUDAMED database. This particular identification number is given to a group of products and is used for administrative purposes only and does not appear on the product packaging.
Under the Basic UDI-DI, there is a more specific UDI-DI which is used for the identification of specific products. This is the static part of the UDI number and does not change.
The UDI-PI is known as the production identifier and is the dynamic part of the UDI and changes depending on each product. It contains information on the Device Identifier number, Expiration date, Lot number and Serial number.
These UDI numbers will be placed on the label of the device and is made of two parts: A UDI-DI and a UDI-PI.
Why is the UDI important?
The UDI number is needed for product tracking through the EUDAMED database. These numbers will be used to provide traceability on all medical devices, allow monitoring by competent authorities and enhance the effectiveness of post-market safety-related activities.
Where can you get a UDI from?
There are currently 4 organisations authorised in giving out UDI numbers.
- HIBCC (Health Industry Business Communications Council)
- IFA GmbH (Informationsstelle für Arzneispezialitäten)
How many numbers do you need?
Both Basic UDI-DI and UDI-DI numbers are composed of maximum 25 characters.
Deadlines for UDI implementation
Below are the UDI implementation dates following the class:
- Class I: 26 May 2025
- Class IIa and IIb: 26 May 2023
- Class III: 26 May 2021
- Implantable devices: 26 May 2021
We understand this is a confusing time for medical device manufacturers. RNI Consulting welcome any questions regarding the new regulations, we’re here to help your business meet these requirements!
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For more information :
- RNI US : firstname.lastname@example.org