MDR = Medical Device Regulation / European Medical Device Regulation

The MDR (Medical Device Regulation (EU) 2017 / 745) entered into force in the EU on 25 May 2017. Although these requirements don’t necessarily apply in the UK since we left the EU, the vast majority of our devices have been manufactured to meet these standards as well as the UK requirements.  The MDR made the following changes:

 

  • 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.
    Please see our declarations of conformity on the bottom of each product page.
  • 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! Please email us: info@vmorthotics.co.uk

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.