Quality Management
The DARCO quality management system aims to continuously optimise and adapt our products as well as our internal structures and processes. Through the externally certified quality management system for medical devices according to DIN EN ISO 13485 in all DARCO areas, we guarantee the highest product quality and optimal service performance.
Medical Device Regulation
MDR = Medical Device Regulation / European Medical Device Regulation
The Medical Device Regulation (EU) 2017 / 745 entered into force on 25 May 2017. It provided for a transitional period. Thus, the regulation is binding within the EU since 26 May 2021.
The MDR made the following changes to ensure that all medical devices are safe and efficient for the customer.
- Definition – What are medical devices?
- Appointment of a “Person Responsible for Regulatory Compliance” (PRRC)
- Introduction of an identification number (UDI): Mandatory for class I devices as of 26 May 2025
- Revision of declarations of conformity:
All medical devices that fall within the scope of European directives require a CE marking and a declaration of conformity with a printed basic UDI. The manufacturer thus declares the conformity of his product with EU directives and standards.
> Go to declarations of conformity
- Changes in clinical assessment
- Tightening of documentation requirements
- Registration in an EU database
- Stricter post-marketing surveillance:
All feedback from the market is evaluated internally to identify potential for improvement at an early stage. If you have any suggestions or notes about DARCO products, we will be pleased to hear from you. Your opinion is important to us!
> Go to contact form
Label
In order to simplify the documentation requirements of our dealers, DARCO is switching to detachable labels.
Parts of the label can be detached for documentation purposes. This ensures clear traceability.
Here you can find an example of a label on the basis of which we explain the individual symbols that can be used.
Explanation of the symbols
1 | Article number
Indicates the manufacturer’s article number, allowing the medical device to be identified.
2 | Product features
Size, colour and property of the product.
3 | Product name
Shows the complete name of the product, possibly legally protected.
4 | Purpose
Translated into 12 languages.
5 | Manufacturer
Shows the name and address of the manufacturer of the medical device.
6 | CH / EC / UK REP
Indicates the manufacturer’s authorised representative:
A | Switzerland
B | EU
C | United Kingdom
7 | Distributor
Displays the name and address of the company that distributes the medical device.
8 | Importer
Indicates the name and address of the company that imported the medical device into the EU.
9 | Batch designation
Serves for identification and traceability of the product and identifies a specific quantity produced on the same day or from the same raw material.
10 | Packaging unit
Quantity of the individual products included in a packaging unit.
11 | Date of manufacture
Indicates the exact day of manufacture in the format YYYY-MM-DD.
12 | Datamatrix code
Contains all information that is also under the UDI symbol as plain text. Information can thus be transferred to digital systems faster and less prone to errors.
13 | Unique device identifier
The UDI consists of:
The UDI-DI (Device Identifier)
(01) A 14-digit GTIN
(Global Trade Item №)
The UDI-PI (Production Identifier)
(11) Production date YYMMDD
(10) Lot №
(17) Expiry date YYMMDD (optional)
14 | Single patient multiple use / Single use
A | Medical device may be used several times on a single patient.
Or
B | Medical device is intended for single use only.
15 | Consult instructions for use
Indicates to the user that it is necessary to follow the instructions for use.
16 | Barcode
Displays the 13-digit EAN code.
17 | CE conformity marking
Certification mark declaring this product‘s compliance with EU legislation
18 | Medical Device
Indicates that the item in question is a medical device.
19 | Version №
For easier assignment, each label template is given a version № in the format YYYY-MM-DD Rev. XX.
20 | Detachable elements
These parts of the label can be detached for documentation, thus ensuring clear traceability.