Companies exporting medical devices to the EU must comply with MDR labeling requirements, or they may face fines, sanctions, or lose access to the EU market.
Labeling Requirements and Instructions for Use of Medical Devices Exported to the EU under MDR
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.
MDR 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)
- 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.
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.
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.
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:
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
– Symbol for Contains Human Blood or Plasma Derivatives
– Symbol for Contains a Medicinal Substance
– Symbol for Contains Biological Material of Human Origin
– Symbol for Contains Biological Material of Animal Origin
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.
Medical devices require a symbol for hazardous substances. IVDs don’t need to use the symbol.
Common Symbols for MDs and IVDs
– Symbol for Translation
– Symbol 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.
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
- 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.
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