T-007-002 Post-Market clinical follow-up (PMCF) Plan

Objective

The Post-Market Clinical Follow-up (PMCF) aims to collect and evaluate information related to the product clinical safety and performance with the objective to:

• Confirm the product safety and performance.
• Update the product clinical evaluation.
• Identify and analyse unknown side-effects as well as to monitor the identified side-effects, contraindications and risks.
• Identify, analyse and monitor emergent risks.
• Identify possible product misuse.
• Verify that the intended purpose adequacy is maintained.

PMCF plan details

• PMCF plan number:
• PMCF plan date:
• PMCF plan version:

Manufacturer contact details

	Manufacturer data
Legal manufacturer name
Address
SRN
Person responsible for regulatory compliance
E-mail
Phone
Fax

Medical device description and specification

	Product information
Product or trade name
Model and type
Product version
General description of the device
Intended purpose
Intended users
Bssic UDI-DI
Intended patient population
Medical condition(s)
Indications
Contraindications
Warnings
List and description of any variants and/or configurations coverred by this plan
List of any accessories covered by this plan
Certificate number (if available)
CND code(s)
Class
Classification rule
Expected lifetime
Novel product (Yes/No)
Novel related clinical procedure (Yes/No)
Explanation of any novel features

PMCF activities

Activity [number]

• Description
• Procedure or method [general or specific]
• Source
• Aim of the Activity
• Procedures to be used
• Rationale and known limitations of the Activity
• Timeline of the activity

Source

• Requested by notified Body
• Clinical evaluation report
• PMS
• Risk management report
• Previous PMCF report
• ...

Aim of the Activity

• confirming the safety of the medical device
• confirming the performance of the medical device
• identifying previously unknown side-effects (related to the procedures or to the medical devices).
• monitoring the identified side-effects and contraindications
• identifying and analysing emergent risks
• ensuring the continued acceptability of the benefit-risk ratio
• identifying possible systematic misuse or off-label use of the device

Procedures to be used

• screening of scientific literature and other sources of clinical data
• post-market studies
• collecting data in registries
• survey from health care professional
• survey from patients/users
• review of case reports which may reveal misuse or off-label use

Rationale

• the justification for sample size, timescales and endpoints
• justification for comparator, on the basis of intended purpose and state of the art
• justification of the study design on the basis of all of the above, and why it is sufficient to ensure representative patient populations and provide for adequate controls on sources of bias (an evaluation of the potential sources of bias should form part of this)
• a statistical justification for the expected quality of outcomes, and justification for why this is satisfactory in light of the residual risks. This is an important consideration. For example, retrospective surveys with no justification other than “this should demonstrate the expected quality of evidence that we require,” but without showing a statistical rationale, are not acceptable.

Reference to relevant parts of the technical documentation

note

In this section we are required to include references to the relevant information from the clinical evaluation report and from the risk management file, which need to be analysed, followed up, and evaluated in this plan. As an alternative, we are required to state that there is no relevant information from the clinical evaluation report and/or from the risk management file to be considered in this plan.

Clinical Evaluation Report (date and version)

• Relevant information to be further analysed and monitored:
• No relevant information from the clinical evaluation report to be considered in this plan

Risk Management File (date and version)

• Relevant information to be further analysed and monitored:
• No relevant information from the clinical evaluation report to be considered in this plan

Evaluation of clinical data relating to equivalent or similar devices

Product name of equivalent /similar device	Intended purpose	Intended users	Intended patient population	Medical condition	Indication	Reference to clinical data evaluation in the CER (date, version and location in the text)

Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s)

When new standards, requirements or guides were applied we will update the corresponing section within the product Technical File.

Common specifitation(s) to comply with, if applicable

Harmonised standards to apply, if applicable

Guidance on PMCF, if applicable

note

Include title, date and version of each document mentioned

Estimated date of the PMCF evaluation report

T-007-005 PMCF evaluation report

note

Establish the date the first version of the PMCF evaluation report. Then establish the periodicity of the review.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001

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• Author: JD-004 María Diez
• Review: JD-005 Alfonso Medela
• Approval: JD-001 Andy Aguilar