MDR Labeling Requirements for Medical Devices Exported to the EU

Minnie Jacobs

The European Union (EU) Medical Device Regulation (MDR), implemented on May 26, 2021, mandates specific requirements regarding the labeling of medical devices.

Medical device manufacturers must comply with these new regulations or risk facing fines, sanctions, or lost access to the EU market.

Labeling Requirements

The manufacturer of medical devices (MD) is responsible for accurate and complete labeling of everything they export. Every MD should have a label indicating the product description and safety and performance details relevant to the end-user.

The label should appear on the product itself or the packaging. Crucial details include the following:

  • Product name
  • Serial number
  • Product identification, contents of packaging, purpose
  • Manufacturer’s details
  • Contact address and details of authorized representative (for manufacturers based outside of the EU)
  • Instructions
  • Warnings or precautions

Importers are responsible for ensuring that the medical device is labeled in accordance with MDR Article 13 and accompanied by the required instructions for use.

The importer’s EUDAMED SRN (Single Registration Number) must also be clearly indicated on the label. This identifies them as an economic operator in the EU market.

Placement

MDR Annex I mandates that the label appears on the product’s surface or the packaging of each unit or multiple units. It should also appear on the manufacturer’s website and be updated.

Further, the information shall be provided on the device itself and must be indelible and clearly legible. If it’s not practicable or appropriate, some or all details may appear on the packaging for each unit and/or on the packaging of multiple devices, as in the case of contact lenses or implants.

Language

There are 24 languages in the EU, all of which are considered official in their specific locations. Information should be available in the user’s preferred language.

user preferred language for label 1

user preferred language for label 2

user preferred language for label 3

user preferred language for label 4

Symbols

Symbols are crucial for labels based on the MDR and In-Vitro Devices Regulations (IVDR). Here are some of the important symbols that appear on the label:

Sterility

Sterility Symbol

This symbol usually appears on medical devices that are sterilized. Most IVDs are not sterilized and would not need this symbol.

Presence of Substance/s

1. Symbol for Contains Human Blood or Plasma Derivatives

Symbol for Contains Human Blood - MDR Labeling

2. Symbol for Contains a Medicinal Substance

Symbol for Contains a Medicinal Substance - MDR Labeling

3. Symbol for Contains Biological Material of Human Origin

Symbol for Contains Biological Material of Human Origin - MDR Labeling

4. Symbol for Contains Biological Material of Animal Origin

Symbol for Contains Biological Material of Animal Origin - MDR Labeling

Some medical devices require symbols that indicate the presence of certain substances. There are separate symbols for devices that contain human blood and plasma derivatives and products that contain a medicinal substance.

There are also different symbols for devices that contain biological products from animals and humans.

Hazardous Substance

symbol for hazardous substances

Medical devices require a symbol for hazardous substances. IVDs don’t need to use the symbol.

Common Symbols for MDs and IVDs

1. Symbol for Translation

Symbol for MDR Label Translation

– Symbol for Repackaging

MDR Label for Repackaging

The common symbols used for both MDs and IVDs are those that don’t have anything to do with healthcare. These symbols are translation, repackaging, importer, and distributor.

eLabeling

The EU mandated the use of electronic instructions for use (eIFUs) in March 2013, which is a more environmentally-friendly practice.

All the eLabels must follow the requirements under the MDR. According to EU regulations, eIFU can only be used in the following devices:

  • Devices and accessories used exclusively by professionals
  • Software
  • Devices with integrated screen display
  • Fixed installed medical device
  • Implantable devices

Further, medical devices classified as Class I and Class IIa or products with low to medium risks do not require instructions.

Importance of Labels on Medical Devices

Medical devices are crucial to healthcare; hence, they should be appropriately handled and labeled accordingly. Important details about the product should be on the label, as well as clear instructions for use.

More Information? GrowthImports

about GrowthImports

We provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements.

Import your medical goods Into Europe with our hassle-free market access importing service while maintaining flexibility, compliance and increased quality standards.

With over 30 years of combined experience, GrowthImports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.

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