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Updated September 16, 2021

Template: SOP Clinical Evaluation

Sven Piechottka
ISO 13485

This is a free template, provided by OpenRegulatory.

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Related Records

The following templates are records of this template. That means that this document mentions them somewhere and you need to fill them out to actually implement whatever this document proposes.
Beginning of template
Regulatory Requirement Document Section
MDD Annex I and X All
MDR Annex XIV All
MEDDEV 2.7/1, rev. 4 All

Summary

This SOP describes the development of medical devices in accordance with regulatory requirements of Annex I and X (MDD) and Annex XIV (MDR) regarding medical device clinical performance. It ensures the level of demonstrated safety and risk-benefit-ratio that is required for our medical devices both for initial certification and for continued safe use in the market.

Process Steps

1.1 Clinical Evaluation Plan

The clinical evaluation is initiated following a Management decision to place a new or updated medical device on the market. The organization follows this process both for initial market placement and for continuous updates during the marketing phase.

The initial clinical evaluation is planned as part of the Clinical Evaluation Plan. During the marketing phase, this plan is continuously updated as part of the Post-Market Clinical Follow-Up.

External partners can be involved in both conducting the initial clinical evaluation and the post-market clinical follow-up in order to ensure higher clinical expertise during the process and lower risk of regulatory nonconformity. In this case, different external partners should be evaluated with regards to sufficient experience (see MEDDEV 2.7/1 rev. 4 section 6.2). The Head of the Medical Team serves as the point of contact to provide all relevant information to the partner.

NOTE: if your organization maintains a purchasing process, the selection of an external partner for the clinical evaluation should be subject to supplier evaluation.

   
Participants Medical Team
Input Initial release: decision on new device, preliminary product specifications (intended use, risk assessment, available preclinical data, information on equivalent devices, etc.)
Output Initial release: completed Clinical Evaluation Plan

1.2 Clinical Evaluation Report

Relevant data is collected and analyzed as part of writing the Clinical Evaluation Report to evaluate the device’s clinical performance. At minimum, the clinical evaluation must take account of:

In the course of data collection and analysis, new risks may be identified and are documented accordingly as updates to the risk management file.

NOTE: where a Notified Body is involved in the conformity assessment of the device and the Medical team identifies remaining uncertainty with regards to the sufficiency of the clinical data, the Notified Body can be contacted to discuss additional measures (e.g. as part of the post-market clinical follow-up) that ensure product conformity and approval.

   
Participants Medical Team
Input Product specifications
Output Completed Clinical Evaluation Report
If necessary: updated risk file

1.3 Post-Market Clinical Follow-Up (PMCF)

Following the initial clinical evaluation, the organization plans the post-market clinical follow-up for the medical device, ensuring its continuous safety and sufficient performance during the marketing phase. The PMCF serves as input to regularly update the clinical evaluation.

The Medical team is responsible to compile and implement a Post-Marketing Clinical Follow-Up Plan, including at minimum:

The CAPA process must be initiated if new information collected as part of the PMCF activities indicates that a balanced risk-benefit-ratio and the safety of the device is in question.

All PMCF activities conducted per PMCF period are documented in a Post-Market Clinical Follow-Up Report.

   
Participants Medical team
Input Clinical Evaluation Report New clinical data during marketing phase
Output Completed Post-Market Clinical Follow-Up Plan and Report
If necessary: PMCF measures (e.g. CAPA, updated risk file, etc.)

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End of template

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