There is not much time left for the MedTech industry to implement the regulatory requirements of the Medical Device Regulation (MDR). The many pages on UDI regulations alone contain numerous terms that must be known. We have summarized them for you.
AIDC
Automatic Identification and Data Capture. This term covers techniques for identification, data acquisition, data collection, and data transmission. E.g., barcode, RFID. Used for the automatic identification of, in this case, medical technology products.
Barcode
One of the machine-readable variants in which the code can be applied.
Basis UDI-DI
Is the primary identifier of a product model. It forms a bracket, so to speak, for different variants of a medical device.
Data Matrix Code
One of the machine-readable variants in which the code can be applied.
Device Identifier (DI)
One of two components of the UDI. This is the product identification and serves to uniquely identify the medical technology product. Alphanumerically or numerically structured, it is static and ISO-based. Also contains the master data. Each UDI-DI is assigned to exactly one basic UDI-DI.
Deadline
By May 2020, the products must already be assigned a UDI-PI, otherwise, the product may not be placed on the market. When the UDI must also be applied to the products differs according to product class. -> see product labeling obligation
EUDAMED
Central database to which the reports must be sent. The original launch date of the database: May 2020. Due to the lack of functionality of most modules, the launch date was postponed to May 2022.
Excel
Theoretically, it is possible to keep the data and UDI in an Excel list. The data can be reported manually to EUDAMED. However, this procedure is only suitable for manufacturers with very few products.
HRI
Human Readable Interpretation. The information must also be printed in plain text on the packaging.
Legacy products
The MDCG has proposed to store legacy devices in EUDAMED without UDI-DI. Status April 2019
Update April 2021: Legacy devices do not need to have a UDI-DI, to maintain the EUDAMED usual data structure, they will be assigned an EUDAMED DI and an EUDAMED ID instead.
Legal acts
The MDR provides for 11 delegated acts and 32 implementing acts. The definition of acts makes the MDR applicable.
MDR
EU directive, deadline: 26 May 2020, replaces two old directives:
– Directive 93/42/EEC on medical devices (Medical Device Directive, MDD)
– Directive 90/385/EEC concerning Active Implantable Medical Devices (AIMD)
Product labeling obligation
The deadline differs for medical devices of different classes, but all data must be stored from May 2020. Update April 2021: The dates for data maintenance in EUDAMED depend on the availability of the individual modules.
Class III and implants: May 2021
Classes IIa and IIb: May 2023
Class I: May 2025
Production Identifier (PI)
One of two components of the UDI. Equals GTIN and is variable. It is the manufacturing ID and therefore contains the manufacturing and expiration date and the serial number.
Quality management system
The complex requirements of the MDR can only be fulfilled by innovations in the quality management of the manufacturers.
Single Point of Truth
Data in large volumes must be kept up-to-date and in compliance with guidelines for up to 20 years. So that nothing can get mixed up, there must be only one place where the data can be managed centrally and where all parties involved must have access. Otherwise, there is a danger that not all versions are up to the same standard.
Storage time
The data must be kept available for up to 20 years, but at least for the duration of the life cycle of the respective product.
UDI
Unique Device Identifiers label medical devices and make them traceable and clearly identifiable. Recall actions are also made easier and counterfeits are identified more quickly.
UDID
UDI database with static data. See EUDAMED
XML
Data format in which the data is exchanged with EUDAMED. The database also allows data to be uploaded as a “bulk upload”, i.e., multiple data in one step. XML uploads to EUDAMED can be done manually or automatically.