inventory_2

SOP Regulatory Strategy

Use this SOP Regulatory Strategy template to define and document your organization’s approach for bringing medical devices to the US and EU markets, covering device classification, regulatory pathways (such as FDA 510(k), PMA, CE Marking), pre-market, and post-market requirements. Complete and maintain this SOP to ensure regulatory compliance, address evolving requirements, and manage the impact of regulatory changes on your products and processes throughout the device lifecycle. This template is essential for regulatory, quality, and product teams and should be filled out and updated before market entry and whenever relevant regulations are updated.
Generate ->

SOP Regulatory Strategy

ID: Lorem ipsum dolor sit amet, consectetur adipiscing elit.

1. Purpose

This SOP outlines the regulatory strategy for medical devices, including hardware and software, for the US and EU markets across all classifications. It also describes how the organization identifies and manages regulatory changes that have the potential to impact the organization or their products.

2. Scope

This procedure applies to all medical devices developed by the company, including both hardware and software components, intended for distribution in the US and EU. It also covers the process for identifying and implementing changes based on new or revised regulatory requirements.

3. Definitions

  • FDA: Food and Drug Administration (US)
  • CE Mark: Conformité Européenne Mark (EU)
  • MDR: Medical Device Regulation (EU) 2017/745
  • Class I, IIa, IIb, III (EU MDR): Device classifications by EU MDR based on risk
  • IVDR: In Vitro Diagnostic Medical Device Regulation (EU) 2017/746
  • Class A, B, C, D (EU IVDR): Device classifications by EU IVDR based on risk
  • Performance Evaluation: Assessment and analysis of data to establish or verify the scientific validity, analytical and clinical performance of an IVD device.
  • Class I, II, III (US): Device classifications by FDA based on risk
  • Notified Body: An organization designated by an EU country to assess the conformity of certain products before being placed on the market.

4. Responsibilities

  • Regulatory Affairs Team: Ensure compliance with regulatory requirements.
  • Product Team: Provide necessary documentation and support.
  • Quality Team: Maintain quality systems and records. Gather information on new or revised regulatory requirements and assess their impact.

5. Procedure

5.1 Regulatory Assessment

5.1.1 US Regulatory Strategy

  • Identify the classification of the medical device according to FDA.
  • Determine the regulatory pathway (e.g., 510(k), PMA).
  • Assess pre-market requirements specific to the device class.
  • Evaluate the need for clinical trials and gather necessary data.
  • Compile a comprehensive list of required documentation.
  • Review FDA guidance documents and standards applicable to the device.
  • Develop a timeline for submission and approval process.
  • Identify potential risks and develop mitigation strategies.

5.1.2 EU Regulatory Strategy

  • Identify the classification of the medical device according to EU MDR 2017/745.
  • Determine the regulatory pathway for CE Marking.
  • Assess pre-market requirements specific to the device class.
  • Evaluate the need for clinical evaluations and gather necessary data.
  • Compile a comprehensive list of required documentation.
  • Review EU MDR guidance documents and harmonized standards applicable to the device.
  • Identify the classification of the IVD device according to EU IVDR 2017/746.
  • Determine the regulatory pathway for CE Marking under IVDR.
  • Assess pre-market requirements specific to the device class (A, B, C, D).
  • Evaluate the need for performance evaluations (scientific validity, analytical and clinical performance) and gather necessary data.
  • Compile a comprehensive list of required documentation per IVDR.
  • Review EU IVDR guidance documents and common specifications applicable to the device.
  • Develop a timeline for submission and approval process.
  • Identify potential risks and develop mitigation strategies.

5.2. Pre-Market Requirements

5.2.1 US Pre-Market Requirements

  • Compile necessary documentation (e.g., 510(k) submission, PMA application).
    • For Class I devices: Prepare and submit a premarket notification if required.
    • For Class II devices: Prepare and submit a 510(k) premarket notification.
    • For Class III devices: Prepare and submit a PMA application.
  • Conduct risk analysis and management.
  • Perform clinical evaluations and trials if required.
    • For Class I devices: Clinical trials are generally not required.
    • For Class II devices: Conduct clinical trials if necessary to demonstrate substantial equivalence.
    • For Class III devices: Conduct clinical trials to demonstrate safety and effectiveness.

5.2.2 EU Pre-Market Requirements

  • Compile necessary documentation (e.g., Technical Documentation).
    • For Class I devices: Prepare a Technical File and self-declare conformity (unless sterile, measuring, or reusable surgical instrument).
    • For Class IIa and IIb devices: Prepare a Technical File and submit it to a Notified Body for review.
    • For Class III devices: Prepare a Technical File (or Design Dossier for legacy devices) and submit it to a Notified Body for review.
    • For Class A devices: Prepare Technical Documentation and self-declare conformity (unless sterile).
    • For Class B, C, and D devices: Prepare Technical Documentation and submit it to a Notified Body for review. Specific requirements apply, including EU reference laboratory testing for Class D.
  • Conduct risk analysis and management according to ISO 14971.
  • Perform clinical evaluations and trials if required.
    • For Class I devices: Clinical evaluation based on literature/equivalence may suffice.
    • For Class IIa and IIb devices: Conduct clinical evaluations; clinical investigations may be needed.
    • For Class III devices: Conduct clinical investigations are generally required.
  • Perform performance evaluations (scientific validity, analytical performance, clinical performance).
    • For Class A and B devices: Performance evaluation based on literature/equivalence or existing data may suffice.
    • For Class C and D devices: Clinical performance studies are generally required. Specific requirements for analytical performance studies apply to all classes.

5.3 Submission Process

5.3.1 US Submission Process

  • Prepare and submit the 510(k) or PMA application to the FDA.
    • For Class I devices: Submit a premarket notification if required.
    • For Class II devices: Submit a 510(k) premarket notification.
    • For Class III devices: Submit a PMA application.
  • Respond to any queries from the FDA.

5.3.2 EU Submission Process

  • Prepare and submit the Technical File for CE Marking.
    • For Class I devices (non-sterile, non-measuring, non-reusable surgical): Self-declare conformity and register the device in EUDAMED. Notified Body involvement for others.
    • For Class IIa and IIb devices: Submit the Technical File to a Notified Body for review.
    • For Class III devices: Submit the Technical File to a Notified Body for review.
  • Prepare and submit the Technical Documentation for CE Marking.
    • For Class A devices (non-sterile): Self-declare conformity and register the device in EUDAMED. Notified Body involvement for sterile Class A.
    • For Class B and C devices: Submit the Technical Documentation to a Notified Body for review.
    • For Class D devices: Submit the Technical Documentation to a Notified Body for review, potentially involving an EU reference laboratory.
  • Respond to any queries from the Notified Body.

5.4 Post-Market Surveillance

5.4.1 US Post-Market Surveillance

  • Monitor device performance and report adverse events to the FDA.
  • Maintain compliance with post-market requirements (e.g., vigilance reporting, periodic safety updates).

5.4.2 EU Post-Market Surveillance

  • Monitor device performance and report incidents and field safety corrective actions (FSCA) to the relevant authorities via EUDAMED.
  • Maintain compliance with post-market requirements (e.g., vigilance reporting, periodic safety updates).
    • Implement a Post-Market Surveillance (PMS) system proportionate to the risk class.
    • Prepare a PMS Plan and PMS Report (Class I) or Periodic Safety Update Report (PSUR) (Class IIa, IIb, III).
    • Conduct Post-Market Clinical Follow-up (PMCF) as defined in the PMCF plan.
    • Implement a Post-Market Surveillance (PMS) system proportionate to the risk class.
    • Prepare a PMS Plan and PMS Report (Class A, B) or Periodic Safety Update Report (PSUR) (Class C, D).
    • Conduct Post-Market Performance Follow-up (PMPF) as defined in the PMPF plan. Update the Performance Evaluation Report (PER) throughout the device lifecycle.

5.5 Input of New or Changed Regulatory Requirements

The quality team is required to prospectively gather information regarding new or revised regulatory requirements that may impact the organization or its products. This information may be gathered from a variety of sources, including but not limited to:

  • Newsletters or resources from standards committees (e.g. ISO, IEC)
  • Competent authority resources (e.g. BfArM, Swissmedic)
  • Consultancy newsletters or resources (e.g. Johner Institute, RQM+)
  • Regulatory websites (e.g. FDA, EU MDR pages on European Commission website, EUDAMED)
  • Common Specifications (CS) published by the European Commission.
  • Regulatory websites (e.g. FDA, EU IVDR pages on European Commission website, EUDAMED)
  • Common Specifications (CS) for IVDs published by the European Commission.
  • Industry publications
  • Word of mouth

Regulations should be reviewed at least once per year and for any particular product prior to placing it on the market for the first time.

6. Changes Based on Regulatory Changes

6.1 Evaluating Regulatory Changes

If new regulatory requirements or changes to existing regulatory requirements that have a potential impact on the organization or the products are identified, a quality team member will investigate whether the changes will have a potential impact on the organization's quality management system, existing products on the market, products in development, and/or processes and resources by reviewing the List of Regulatory Requirements and the existing product processes.

If there is indeed a potential impact, the quality team shall update the List of Regulatory Requirements with the updated requirements. Following an update of the List of Regulatory Requirements, the quality team will assess which, if any, marketed or developing products or processes require changes. If changes appear to be required, a gap assessment shall be carried out to understand what specific changes are needed in order to meet the new requirements.

6.2 Gap Assessment and Implementing Changes

The gap assessment will be carried out by the quality team and the teams related to the process and/or products that require changes. A gap assessment form shall be filled out that includes the following information:

  • Previous regulatory requirements
  • New regulatory requirements
  • Actions planned in order to address the change in requirements
  • Result of implemented actions

The gap assessment shall be saved in the QMS as a record. Changes that are implemented to a marketed device should be implemented according to the SOP Change Management whereas other changes are implemented directly.

7. Communication and Evaluation of Changes

The quality team communicates any new or revised regulatory requirements to relevant members of the organization for whom the change is directly related. Management shall be informed of new or revised regulation as part of the Management Review or sooner as needed.

References

  • FDA 21 CFR Part 820
  • EU MDR 2017/745
  • EU IVDR 2017/746
  • ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
  • ISO 14971:2019 - Medical devices – Application of risk management to medical devices

Medical Device Certification Made Easy.