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MDR

Regulation (EC) 2017/745 on medical devices (MDR) came into force on 25 May 2017. However, the legislative authority allowed a three-year transition period, which has been extended for a further year as a result of the Coronavirus pandemic.

MDR - What is it?

Nothing is changing for DARCO clients!

Thanks to our thorough preparatory work, the transition has been almost imperceptible for DARCO clients. Our product range has not changed as a result of the MDR. It has also not been necessary to make any changes to our products, such as the introduction of UDI codes or design changes, as we have already been fulfilling these requirements for several years. Our motto holds true: "DARCO - Always one step ahead". As a result, we can continue to offer our first-rate service and guarantee a constant ability to supply.

The changes

Definition of a medical device

In the future, many more products will be defined as medical devices and/or will fall under higher classification rules.

Appointment of a Qualified Person for compliance with regulatory requirements

Each manufacturer must appoint an appropriate Qualified Person within their company. This person shall be responsible for making sure that specific requirements are met within the respective company. At DARCO, these duties are split between three people: Thomas Dietrich, Regina Felix and Sieghard von Luxburg.

Clinical assessment

The requirements for clinical assessment have been tightened. The fundamental safety and performance requirements must be demonstrated using clinical data.

Increased documentation

The MDR requires comprehensive technical documentation from manufacturers. In order to be able perform this additional work and continue to provide this more comprehensive documentation in a seamless manner, DARCO has taken on board additional staff.

No right of continuation for existing medical devices

Even products that have been on market for a long time must meet the requirements of the MDR and go through the required conformity assessment processes. This applies to products manufactured by DARCO.

Identification number

Each medical device must have a unique device identifier (UDI). For Class I devices, this applies from 26.05.2025.

Declarations of conformity

All medical devices falling under the scope of European regulations require a CE mark and a corresponding declaration of conformity. This is a declaration from the manufacturer that its devices conform with European guidance and standards. The respective Basic UDI must also feature on this.

All declarations of conformity for DARCO products can be found here

Post-market surveillance

Close monitoring of marketed medical devices shall take place to maintain the quality, safety and performance of the device throughout its entire life cycle. This must take place through collaboration between wholesalers, manufacturers and users.

Product labelling -
Overview of symbols and terms

MDR Product labelling - Overview of symbols and terms
LOT (batch number):
The LOT number is used to identify and trace manufactured devices. It is issued by the manufacturer and is used to label a certain production quantity, for example devices produced from the same delivery of raw material, or a quantity produced on the same day.
UDI (Unique Device Identifier = device identification number):
The UDI is a worldwide system for uniform product identification of medical devices. The UDI consists of a UDI-DI and UDI-PI:
UDI-DI (device identifier) is a registration number for a group of medical devices with the same intended use, same risk class and comparable construction and manufacturing characteristics. It comprises the 14-digit GTIN (01), which is unique for each article variant and which contains the prior EAN (e.g., coding of the packing unit + EAN). The Global Trade Item Number (GTIN) is an international, distinctive number for the identification of products. It is assigned at a global level by GS1.
The UDI-PI (PI = Production Identifier) changes for each individual item and comprises the following information:
(10): LOT (production batch)
(11): Date of production in YYMMDD format
If applicable, (17): Expiry date
Datamatrix code:
All information visible in plain text under the UDI icon also can be found coded in the adjacent datamatrix code for simple recording in your system. Addition of an UDI to the packaging labels is subject to a transition period of 5 years (for our products, this means until May 2025).