Template: SOP Clinical Evaluation

Regulatory Requirement Document Section
MDR Annex XIV All
MEDDEV 2.7/1, rev. 4 All
MDCG 2020-6 All

Overview

This SOP outlines the process for developing medical devices in compliance with the regulatory requirements of MDR Annex XIV regarding clinical performance. It ensures that the demonstrated safety and risk-benefit profile required for medical devices is met, both for initial certification and for continued safe use in the market.

Process Owner \
Key Performance Indicators \

Process Steps

1.1 Clinical Evaluation Plan

The clinical evaluation begins with a management decision to launch a new or updated medical device. This process applies both to initial market entry and ongoing updates during the device’s lifecycle.

The initial clinical evaluation is structured through a Clinical Evaluation Plan, which is updated regularly as part of the Post-Market Clinical Follow-Up.

To enhance expertise and reduce the risk of regulatory noncompliance, external partners may be involved in both the initial evaluation and post-market follow-up. These partners should be assessed for sufficient experience as per MEDDEV 2.7/1 rev. 4 section 6.2. The \ serves as the primary contact, ensuring all necessary information is provided to the partner.

Note: If the organization maintains a purchasing process, selecting an external partner for the clinical evaluation should include a supplier evaluation.

Aspect Details
Participants Medical Team
Input For initial release: decision on new device, preliminary specifications (e.g., intended use, risk assessment, preclinical data, data on equivalent devices).
Output For initial release: completed Clinical Evaluation Plan.

1.2 Clinical Evaluation Report

Data is gathered and analyzed to develop the Clinical Evaluation Report, which assesses the device’s clinical performance. The evaluation must address:

  • Intended use, including target users, patient populations, and device features.
  • Supporting data for equivalence with other devices, if applicable.
  • State-of-the-art technological context.
  • Assessment of clinical data quality and its adequacy to support a favorable risk-benefit ratio and compliance with General Safety and Performance Requirements (MDR).

Any new risks identified during data analysis must be documented and incorporated into the risk management file.

Note: If a Notified Body is involved in the conformity assessment and uncertainties regarding clinical data adequacy arise, it may be contacted to discuss additional measures, such as further post-market clinical follow-up activities, to ensure product conformity.

Aspect Details
Participants Medical Team
Input Product specifications
Output Completed Clinical Evaluation Report; updated risk file, if needed.

1.3 Post-Market Clinical Follow-Up (PMCF)

After the initial clinical evaluation, a Post-Market Clinical Follow-Up (PMCF) is planned to ensure the device’s ongoing safety and performance during its marketing phase. PMCF findings are used to update the clinical evaluation periodically.

The Medical Team is responsible for developing and implementing the PMCF Plan, which includes:

  • Data collection methodology and justification for the chosen approach.
  • Analysis of new data related to the risk management file, clinical claims, or applicable regulations.
  • Specification of the PMCF period (typically not exceeding one year), along with a timeline for PMCF activities and subsequent clinical evaluation updates.

If PMCF data indicates safety concerns or an imbalanced risk-benefit ratio, the CAPA process must be initiated. All PMCF activities are documented in a Post-Market Clinical Follow-Up Report.

Aspect Details
Participants Medical Team
Input Clinical Evaluation Report; new clinical data from the marketing phase.
Output Completed PMCF Plan and Report; additional measures if required (e.g., CAPA, updated risk file).

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