There is not much time left for MedTech industry to implement the regulatory requirements of the Medical Device Regulation (MRD).The many pages on UDI regulations alone contain numerous terms that need to 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, RIFD. 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 labelling obligation

EUDAMED

Central database to which the reports must be sent.

Excel

Theoretically, it is possible to keep the data and UDI in an Excel list.

HL7

The international standard Health Level Seven (HL7) also applies to data exchange with the UDI database.

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 products in EUDAMED without UDI-DI. Status April 2019

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 labelling obligation

The deadline differs for medical devices of different classes, but all data must be stored from May 2020.

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 will be on the same stand.

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