the FDA’s labeling requirements as outlined in 21 CFR Part 801. The label should include:
– Device Name: The name of the device, which may include the brand and model number.
– Indications for Use: A clear statement of the medical purpose of the device.
– Contraindications and Warnings: Information on conditions under which the device should not be used, including potential risks.
– Instructions for Use (IFU): Clear and concise instructions on how to use the device safely.
– Sterility and Shelf Life Information: If applicable, the sterility status of the device and expiration date.
– Manufacturer Information: The name and address of the manufacturer, including the establishment registration number.
– Lot or Batch Number and Serial Number: For traceability purposes.
– Cautionary Statements: Any relevant safety instructions or warnings.
– Regulatory Symbols: Use FDA-recognized symbols where necessary (e.g., “Rx only,” “CE” symbol for the EU).

4.1.2 Label Format and Language
– Label text should be legible, clearly presented, and formatted according to FDA requirements:
– Use clear fonts and large text sizes for important information.
– Ensure that all critical information is easy to read in all lighting conditions.
– Provide labeling in English, with additional languages as needed for international markets.
– Maintain uniformity in label design, including consistent placement of required elements.

4.2 EU MDR Labeling Requirements
4.2.1 Label Content for EU MDR Compliance
– Ensure that medical device labels comply with the European Union Medical Device Regulation (MDR 2017/745). The label should include:
– Device Name and Model: The full name and model number of the device.
– Manufacturer Information: The name and address of the manufacturer, including the Authorized Representative (if applicable).
– Intended Purpose: Clear indication of the device’s intended use and the conditions for use.
– CE Mark: The CE marking with the four-digit number of the Notified Body, indicating conformity with the EU MDR.
– UDI (Unique Device Identification): The UDI code, which includes the device’s identification number and lot number.
– Warnings and Precautions: Warnings, precautions, and contraindications to avoid misuse of the device.
– Batch/Lot Number and Serial Number: To facilitate traceability.
– Expiry Date (if applicable): For devices with a limited shelf life.

4.2.2 Additional Labeling for EU Compliance
– Ensure that additional information is provided as per the specific device classification and intended use:
– Sterilization Information: Whether the device is sterile, and the sterilization method used.
– Post-market Surveillance: Information about the manufacturer’s post-market surveillance requirements.

4.3 Label Design and Review Process
4.3.1 Label Design
– Create label designs that meet the regulatory requirements and ensure that all necessary information is included. Key considerations for label design include:
– Clarity and Legibility: Ensure that the label text is clear, legible, and understandable by the target user.
– Consistent Layout: Organize the information logically, with the most critical information placed prominently.
– Pictograms and Symbols: Use standardized pictograms and symbols as defined by regulatory guidelines (e.g., ISO 15223-1 for medical device symbols).

4.3.2 Label Review and Approval
– Establish a process for reviewing and approving labels before production:
– Internal Review: The QA and Regulatory Affairs teams should review the label content for compliance with FDA and EU MDR requirements.
– Cross-functional Review: Label approval should involve multiple departments, such as R&D, Manufacturing, Marketing, and Regulatory Affairs.
– Regulatory Check: Regulatory Affairs must ensure that the label meets all applicable legal requirements in the target market(s).
– Document Control: Maintain records of label reviews, approvals, and any revisions.

4.4 Label Printing and Application
4.4.1 Label Printing
– Ensure that labels are printed with high-quality printing methods that ensure:
– Durability of the label, especially when exposed to harsh environments (e.g., moisture, UV light).
– Use of permanent ink for barcodes, expiration dates, and other critical information.
– Proper placement of the CE mark, UDI, and other regulatory symbols.

4.4.2 Label Application
– Ensure that labels are correctly applied to the medical devices during the manufacturing process:
– Labels must be securely attached to the device or packaging to avoid accidental detachment during transportation or storage.
– Ensure that the label is placed in a visible location on the device packaging, ensuring easy identification.

4.5 Label Change Control and Versioning
4.5.1 Label Change Process
– Implement a change control process to manage updates to the label, ensuring that any changes comply with regulatory requirements:
– Change Identification: Identify and document the reasons for changes to the label (e.g., regulatory updates, product changes).
– Approval Process: Ensure that any changes to the label are approved by the Regulatory Affairs, QA, and Document Control teams.
– Traceability: Maintain records of previous and current label versions for traceability.

4.5.2 Label Version Control
– Maintain a version control system for labels to ensure that only the approved label versions are used:
– Each label version must be uniquely identified with a version number and approval date.
– Store archived versions of labels for compliance purposes.

4.6 Documentation and Record Keeping
4.6.1 Label Documentation
– Maintain detailed documentation related to label creation, approval, and revisions:
– Approved label versions, including digital copies of labels.
– Regulatory compliance checks and approvals.
– Records of the label review process and any change approvals.

4.6.2 Record Retention
– Retain records of label designs, approvals, and revisions for a minimum of five years or as required by regulatory authorities.

4.7 Compliance and Regulatory Inspections
4.7.1 Compliance with Regulatory Standards
– Ensure that labeling processes comply with the following standards:
– FDA 21 CFR Part 801: Medical Device Labeling.
– ISO 13485: Medical Devices – Quality Management Systems.
– EU MDR (Regulation (EU) 2017/745).
– ISO 15223-1: Symbols to be Used with Medical Device Labels.

4.7.2 Regulatory Audits and Inspections
– Provide all necessary documentation related to labeling during regulatory inspections or audits, including:
– Label approval records.
– Change control logs.
– Evidence of regulatory compliance.

5) Abbreviations

– FDA: Food and Drug Administration
– EU MDR: European Medical Device Regulation
– UDI: Unique Device Identification
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– ISO: International Organization for Standardization

6) Documents

– Label Design Specifications
– Label Review and Approval Records
– Label Change Control Log
– Label Version Control Records
– Regulatory Compliance Checklists

7) Reference

– FDA CFR Title 21, Part 801: Medical Device Labeling
– ISO 13485: Medical Devices – Quality Management Systems
– ISO 15223-1: Symbols to be Used with Medical Device Labels
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Label Review and Approval Log Template

Date	Label Version	Reviewed By	Approval Status	Remarks
DD/MM/YYYY	V1.0	Regulatory Affairs	Approved	No changes needed

Annexure 2: Label Change Control Log Template

Date	Change ID	Description of Change	Approved By	Reason for Change
DD/MM/YYYY	CC-001	Updated expiration date format	Regulatory Affairs	New regulatory requirement