MDR Labelling Requirements in the EU:What Manufactures Need to Know [Free Tool]

The EU MDR 2017/745 came into force in May 2021, and brought with it additional labelling requirements for medical devices in Europe. Annex II, Section 2 “Information to be supplied by the manufacturer”, covers the requirement for MDR labelling as part of the device technical documentation. This information relates to the device label and the instructions for use, which are defined in the regulation as follows:

MDR Vs MDD Labelling Requirements

The more prescriptive labelling requirements for what is demanded of this can be found under GSPR 23 in Annex I of the MDR. This GSPR, broken down into four subsections, contains a total of 65 requirements. In comparison, the 13th Essential Requirement of Medical Device Directive 93/42/EEC, outlined 35 requirements in relation to the information to be supplied by the manufacturer. The most significant labelling updates that are newly required under the regulation can be summarised as follows:

• the requirement for identification of the presence of substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) above 0.1% w/w,
• the requirement for identification of the presence of substances that have endocrine disrupting properties above 0.1% w/w,,
• the introduction of a Unique Device Identifier (UDI) and
• the Medical Device symbol.

What’s included in an MDR compliant label? 

The necessary components of an MDR compliant label can be found in Section 23.2 of Annex I. Along with the presence of a CE mark, these components include the following:

• Device and manufacturer identification,
• An indication that the device is a medical device,
• EU Authorised Representative information (if applicable),
• Importer information (if applicable),
• An indication of the inclusion of medicinal, biological, or hazardous substances,
• Lot number or serial number,
• UDI,
• Manufacturing/expiration date,
• Required storage conditions,
• Warnings and precautions,
• Information pertinent to specific types of devices, such as:
  • single-use (refer to Section 23.3)
  • custom-made
  • for clinical investigation only
  • active implantable devices

Requirements of a compliant MDR Instructions For Use (IFU)

The requirements of a compliant MDR Instructions For Use can be found in Section 23.4 of Annex I and include the following elements:

• The particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2,
• The intended purpose,
• A specification of the clinical benefits of the device, or information related to the lack thereof, as appropriate,
• A link to the summary of safety and performance (implantable and class III devices),
• Performance characteristics,
• Identification of residual risks, contraindications, and side effects,
• The circumstances under which a lay user should consult a professional,
• Information to allow the user to verify the device suitability, to select the appropriate accessories, and that the device is ready to perform safely,
• Any specifications that are required for the appropriate use of the device,
• Details of required preparatory treatment, special facilities, training, or qualifications,
• Information related specifically to sterilisation, single-use devices, device reuse, and implantable devices,
• Warnings and precautions,
• Date of issue and revision of the IFU,
• Reporting information in the case of the occurrence of a serious incident,
• IT requirements for devices incorporating electronic programmable systems.

As per GSPR 23.1 (d), in some circumstances an IFU may not be deemed a requirement for class I and class IIa devices, provided that these devices can be used safely without instruction. It is however recommended that a rationale for the safety and appropriateness of this approach be included in the technical documentation.

As per GSPR 23.1 (d), in some circumstances an IFU may not be deemed a requirement for class I and class IIa devices, provided that these devices can be used safely without instruction. It is however recommended that a rationale for the safety and appropriateness of this approach be included in the technical documentation.

Use of symbols in MDR labelling 

In so far as possible, recognised symbols should be used to aid in the communication of the necessary information in order to allow for the increase of information without affecting legibility or space constraints. The use of symbols will also remove the need for translation of the relevant information into the EU languages of the countries into which the device is intended to be sold. Refer to EN ISO 15223-1 to identify what recognised symbols you can apply to your labelling in place of text.

​Further economic operator responsibilities

Manufacturers located outside of the European Union must appoint an Authorised Representative within the EU. In these cases, the name and address of the EUAR must be present on the device label. In addition to the EUAR labelling requirements, importers of medical devices into the EU must include their name and address on the device, its packaging, or in a document that will accompany the device. Any additional label that is applied to the device with this information must not obscure the information that the manufacturer has included on the device label or packaging. 

While there are no additional requirements for distributors to include their information on a medical device label, as per Article 14 of MDR distributors of a medical device within the EU must ensure that all of the applicable labelling requirements have been met by the manufacturer, and where applicable, by the EUAR and importer.

Free Tool: MDR Labelling Requirements Identifier

The increase in requirements and any associated labelling changes brought about by the MDR will have varying levels of cost and resourcing implications for manufacturers. We have created a free MDR labelling requirements tool to indicate what requirements of GSPR 23 apply to your device.

Need support achieving MDR compliance in your labelling?

At Trinzo, we are here to support you in achieving MDR compliance in your labelling by:

• Reviewing your existing labelling to identify what changes need to be made for MDR
• Identifying the subsections of GSPR 23 that apply to your specific device(s)
• Identifying the ISO 15223-1 symbols that are applicable to your device(s)
• Remediating your existing IFU to meet the more stringent MDR requirements
• Advising on the applicability of an IFU for your specific device(s) and generation of a suitable rationale where appropriate
• Providing guidance on the UDI requirements for your device(s)