How IVD Manufacturers Can Prepare for IVDR Labeling Requirements

Given their scope, the labeling requirements established under the IVDR can be daunting for manufacturers, even for legacy device manufacturers. Therefore, it is more important than ever for manufacturers to be well-prepared and include activities for IVDR labeling conformity in their IVDR regulatory compliance strategies, and that such strategies leverage a multi-disciplinary approach with organizations. 

Considerations for fulfilling IVDR labeling requirements

Manufacturers should be well-prepared to include activities for fulfilling IVDR labeling requirements in their IVDR regulatory compliance strategies and leverage a multi-disciplinary approach by working with organizations.

Below we discuss several considerations in planning such activities to conform with IVDR labeling requirements: 

Identify the relevant IVDR labeling requirements 

Labeling requirements under the IVDR go beyond those established under GSPR 20 regarding the label and instructions for use (IFU). Other IVDR requirements relevant to device labeling include: 

• • Prohibitions pertaining to device claims made in labeling, IFU, making available, putting into service, and advertising of devices under Article 7 

• • Compliance with Unique Device Identification (UDI) requirements established throughout the regulation, primarily under Article 24 and Annex VI 
  • Indelibility, understandability, and language requirements (Article 10(10)) 
  • The obligation for importers to be identified in labeling under Article 13(3) 
  • Determination of the applicability of Article 16 provisions pertaining to device labeling 
  • For Class C and D IVDs, describing the location of the Summary of Safety and Performance (SSP) on the label or IFU (Article 29(1)) 

• • Ensuring that other applicable GSPR pertaining to labeling are identified, including: 

• • Informing users of any residual risk (GSPR 3(4)) 
  • Distinguishing between identical or similar sterile and non-sterile devices (GSPR 11.6) 
  • Restrictions on use with other devices or equipment (GSPR 13.1) 
  • Operating instructions content for devices emitting hazardous or potentially hazardous radiation (GSPR 15.3) 

• • Information on parts and/or their housings to protect against fitting risks (GSPR 18.7) 
  • Requirements relevant to devices intended for self-testing or near-patient testing under GSPR 19 

Those requirements relevant to the device family and manufacturer’s QMS could be clearly identified by personnel from your regulatory department. 

Determine QMS impacts 

In EN ISO 13485-certified quality management systems (QMSs), labeling processes and labeling conformity will be established and controlled. This includes controls for: 

• • Identification and traceability 
  • Product labeling and packaging activities 
  • UDI management 
  • Translations 
  • Design and development 

• • Regulatory conformity 

Furthermore, as IVDR labeling requirements include those with which importers must comply, manufacturers should ensure that adequate supplier controls are in place with their importers to address these requirements 

Your quality department could identify those QMS processes and documents impacted by the IVDR changes or the need to establish new labeling controls to address such requirements. 

Identify (potentially) impacted labeling materials 

The IVDR establishes requirements that impact different types of labeling materials, including labels, instructions for use, operating manuals, advertising and websites. Some of these may be managed by your quality or marketing departments or both. All (potentially) impacted materials should be clearly identified by your organization and it is recommended that this involve members across your regulatory, quality and marketing departments. 

Identify and address design V&V gaps 

Usability of self-testing and near-patient testing devices is an area of increasing Notified Body focus under the IVDR with more robust usability requirements established under the regulation. Manufacturers of such devices should review design verification and validation documentation to ensure that appropriate usability studies involving device labeling have been established and that the impact of any changes made to device labeling for IVDR conformity are assessed against usability data to ensure that study conclusions remain valid or identify the need for additional testing. 

The intended purpose of an IVD has an even stronger central role under the IVDR and the regulation includes several considerations for content of an intended purpose statement. Changes to the intended purpose statement for improved conformity with IVDR labeling requirements could have a cascade effect across design and development documentation, including the risk management file and performance evaluation. The impact of such changes should therefore be meticulously assessed by your design team. 

Technical documentation file preparation 

Lastly, once all the above considerations have been addressed, it’s time for your regulatory and/or design team to ensure that the technical documentation file is prepared appropriately to demonstrate conformity with the IVDR labeling requirements. This includes ensuring that all translations of labeling content used in devices placed on the market are included in the file. 

Importance of fulfilling IVDR labeling requirements

Manufacturers should include activities for IVDR labeling conformity in their IVDR regulatory compliance strategies and such strategies should leverage a multi-disciplinary approach with organizations.

The IVDR labeling requirements established under the IVDR can be daunting for manufacturers, even for legacy device manufacturers.

Contact us with questions on IVDR labeling requirements or to work with our team.

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