MDR Vs MDD Labelling Requirements

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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:

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• 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.

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What's included in an MDR compliant label? 

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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:

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• 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

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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:

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• 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.

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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.

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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.