Technical documentation section 1. Device description and specifications:

1.5 Qualification as a medical device and classification

The Qualification as a medical device and classification document is a key component of the Technical File for regulatory compliance under MDR 2017/745. It establishes whether a product qualifies as a medical device, defines its classification based on risk, and outlines the applicable conformity assessment procedure. This document ensures regulatory transparency by providing a structured evaluation of the device’s intended use, functional capabilities, and classification criteria. It serves as a critical reference for manufacturers, regulatory bodies, and notified organizations in assessing compliance requirements.

General document information

• Document Title: Qualification as a medical device and classification
• Document ID: Unique identifier for tracking purposes (e.g., TF-QUAL-01)
• Version Number: Version history for tracking changes
• Effective Date: The date when the document becomes applicable
• Approvals: Includes roles such as Originator, Reviewer, and Approver with corresponding names, departments, and signatures

Background and scope

• Overview of the product in question and its modules
• Indication of whether all modules qualify as a medical device under MDR 2017/745 or if only specific components fall under the regulation
• Reference to related sections of the Technical Documentation (e.g., the Device Description Document)

Qualification as a medical device

• Definition Reference: Citing the legal definition of a "Medical Device" according to MDR 2017/745
• Product Analysis:
  • Explanation of how the product aligns with MDR criteria
  • Description of its intended use, including diagnostic, monitoring, or therapeutic functions
  • Justification for qualification as a medical device
• Supporting Explanation:
  • Detailed breakdown of how the product is used in clinical settings
  • Discussion of functionalities that support decision-making in healthcare

Classification of the medical device

• Definition of your medical devices (e.g. active, invasive, implantable):
  • Explanation of relevant MDR definitions, including what constitutes a medical device of this type
  • For software: clarification of whether the product is standalone software or interacts with other hardware
• Application of MDR Classification Rules:
  • Listing of all classification rules according to Annex VIII, MDR
  • Tabulated Classification Analysis:
    • Rule Number
    • Applicability (Yes/No)
    • Justification
    • Resulting Class
  • Determination of strictest classification rules applicable to the device
• Final Classification:
  • Summary of the highest classification resulting from the MDR rules
  • Expected classification of the device (Class I, IIa, IIb or III)

Conformity assessment procedure

• Reference to the corresponding regulatory pathway (e.g. MDR Article 52):
  • Identification of the required conformity assessment procedure based on classification
• Compliance Steps:
  • Overview of necessary regulatory steps for market authorization
  • Documentation required for assessment

Confidentiality and circulation

• Statement restricting document distribution
• Conditions under which the document may be shared (e.g., written approval from the manufacturer)