1.Medical Device development and lifecycle management under the MDR and IVDR

1. Medical Device development and lifecycle management under the MDR and IVDR

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For all devices, manufacturers must provide technical documentation as well as plan, establish document, implement, maintain and update a Post-Market Surveillance (PMS) system, to actively and systematically gather, record and analyse relevant data on the quality, performance and safety of their device throughout its entire lifecycle.

The following text and figure (Figure 1) exemplary and briefly describe the steps in the development of Medical Devices and their lifecycle management. (Adapted from [1]) from the manufacturer’s perspective. There are many instances (see Lesson 3, Figure 1) where patient input can and should be sought.

Figure1: The phases of the Medical Device lifecycle (adapted from [1])

1.1. Research: Idea – initiation and feasibility phase

The idea for a Medical Device often starts with an identified need. Initiating first steps involves an iterative process of research the results of which feed into shaping, modifying and finally deciding on either to abandon an idea or to pursue it. Research might encompass questions such as:

• How feasible is it to develop a successful product?
• What data are needed?                                                                    
• What will be the intended use of the invention? Who will use it?         
• Is it a Medical Device according to the definitions in the regulations?
• What risk class would the Medical Device be assigned to?
• What launch markets are suitable and what will be the regulatory strategy?
• What is the possible competitors’ landscape?
• Which investments are required?

1.2. Design and development (D&D) phase

The goal of the D&D phase is to demonstrate that the device:

• • is safe to use                                                                                         
  • meets the user needs                                                                       
  • meets legal requirements
  • specifications meet the functional requirements,
  • can be manufactured with the available resources

The complete D&D trajectory

• • should follow an approved D&D plan
  • contains all information documented in the D&D files, e.g,
    • risk management,
    • clinical evaluations,
    • document control, training, etc. 

• • contains a Quality Management System (QMS):
    • includes verification and validation to determine if there is objective evidencethat both the design inputs (verification) and intended use (validation) are met,    
    • clinical evaluations
    • documented within the QMS as part of the D&D files.

• • Design transfer includes among others
    • the development and validation of manufacturing processes, upscaling
    • trainings,
    • supplier products specifications,
    • maintenance instructions.

In parallel with the D&D process, the registration process takes place in which the technical documentation is prepared that demonstrates the conformity of the device with the technical requirements of the MDR (according to Annex II and III, MDR) and prior to drawing up the EU declaration of conformity.

1.3. Device production phase

• • further expansion of the QMS, e.g.,
    • a batch release process
    • Quality Control (QC) procedures
    • change control processes
    • complaint management processes

1.4. Post Market phase

• • Post Market Surveillance (PMS) plan and process                               
  • Market surveillance [1]
  • Proactive post market clinical follow-up (PMCF)                                   
  • Continuous assessment of the risk management system (continuous iterative process over the entire lifecycle of a device, regular systematic updating), which will allow:
    • the identification and analysis of the hazards associated with each device,
    • estimation and evaluation of the associated risks,
    • elimination or control of residual risks
    • evaluation of the adopted measures based on the information collected from the post-market surveillance system.

1.5. Lifecycle management

Lifecycle management includes:

• • revisiting D&D (e.g., changes to the device or manufacturing process design)
  • incorporating feedback from post market surveillance (PMS) and market surveillance 
  • incorporating new insights from e.g., complaints
  • risk management, clinical evaluation processes and PMS will be interdependent and will be periodically updated.

1.6. Reference

[1] From idea to post market surveillance: the phases of the medical device lifecycle. Wim Steenackers Business Development Manager at Quality by design; Medical Devices & IVD; April 26, 2021