Post Market Clinical Follow Up

When conducting Post Market Clinical Follow Up, the manufacturer shall proactively collect and evaluate clinical data obtained with the aim of confirming the safety and performance throughout the expected lifetime of the device for ensuring the continued acceptability /suitability of identified risks (residual risk) and of detecting any emerging new risks on the basis of factual evidence collected.

If a Medical Device has gained CE Marking based on clinical evidence from a substantially equivalent and similar device, it is a must to conduct PMCF Plan.

If the manufacturer has provided long-term clinical data on the actual device to demonstrate safety, performance, intended use, and stability, a post-market clinical follow-up study may not be necessary.

This page provides important information to be followed by the Organization for conducting Post-market clinical follow-up studies as per MEDDEV 2.12/2 rev 4 as part of maintaining Notified Body CE Certificate.

A Clinical follow-up study is carried out in cases any residual risks are identified or not clear on long term clinical performance that may impact the benefit/risk ratio.

In order to provide evidence of the long term safety and performance of the device, data received via PMS and PMCF are considered most useful for updating the CER throughout the life cycle.

PMCF is a must where there is very limited clinical data for a legacy device and becomes vital where long term data gaps or unanswered questions related to the usage of the device and certain indications, or novel features of a new device exists.

Post Market Clinical Follow Up Plan (PMCF Plan)

As per the new Medical Device Regulation (EU MDR), the Plan shall be a continuous process that updates the Clinical Evaluation Summary Reports and shall be addressed in the manufacturer’s PMS Plan. A PMCF study plan is executed considering the following points

• • PMCF study plan must be designed with the aim to confirm the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks based on factual evidence.

• • PMCF plan must contain the period of study, plan number, PMCF procedure, date of planning, device information, and also confirm or disprove the acceptability of the previously identified risks, discover new risk and evaluate clinical safety and performance.

• • The PMCF plan should describe the appropriate methodology selected for the study

• • PMCF plan should contain inclusion and exclusion criteria

• • PMCF plan should describe the process of clinical data analysis and interpretation of the results.

• • Data to be collected

• • Special control measures needed to be considered and adopted during the study must be identified in the plan

• • PMCF plan should be filled with the respective details with authorization of the personnel prepared by, reviewed by and approved

A PMCF study Plan will help manufacturers and Notified Bodies in the following manner:

• • Demonstrate, for its intended use, clinical safety and performance of a device through its lifetime and

• • Device’s performance to a broad spectrum of physicians and patients.

• • The Plan should have adequate interim follow-up periods for early detection of problems as well as long-term follow-up.

• • The procedure, plans, and relevant records should be controlled and submitted to NB.

Circumstances under which PMCF study to be initiated

• • Novel medical technology

• • High product-related risk

• • High-risk implant/drug-device combination

• • Pediatric use high-risk devices

• • The worst case use scenario [ Severity/Treatment / hard to reach areas]

• • Unanswered questions of long-term safety and performance

Post Market Clinical Follow up Methodology

The most common methodologies adopted for PMCF studies are the following

• • Extended follow up of patients enrolled in premarket investigations

• • A new clinical investigation

• • A review data derived from the device registry.

• Review of relevant retrospective data from patients previously exposed to the device

Periodic Safety Update Report 

The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices. PSUR is for devices that are low to high-risk, such as Class IIa, IIb, and III. Post-Market Surveillance provides input to Periodic Safety Reports (Results and conclusions of PMS data, vigilance reporting and current status of these devices on the European Market).

The new Medical Device Regulation (MDR) has greatly expanded the standards for tracking medical devices after they have been released to the market and are being used by consumers or patients. The manufacturer must incorporate and track a surveillance device as part of Harmonized Standard EN ISO 13485:2016, according to MDR/IVDR Chapter VII.

• • Post market data collected.

• • Methods for analyzing the collected data

• • Actions taken to counter the data

• • Actions taken such as CAPA, Vigilance, Recall etc.;

• • Analysis and Conclusion of Data

The above are collected and documented as per PMS Plan mentioned in article 84 and article 79 in MDR & IVDR respectively. MDR / IVDR class 1 device permitted to keep Post Market Surveillance Report (PMSR) and Class 11a, Class 11b & Class 111 products Periodic Safety Update Report (PSUR)

Content of Periodic Safety Update Report (PSUR)

The contents of this report are outlined in Article 86 of the MDR listed below.

• • Summary of the PMS and covering findings of Post Market Clinical Follow Up (PMCF)

• • Data analysis and Conclusions / Result

• • CAPAs taken against actions.

• • Result of Risk Analysis / Residual Risks

• • Sales volume, Geographical Location, User group

Periodic Safety Update Report (PSUR) Timeline

Role of I3CGlobal in writing and documenting PSUR

• • Development of Procedures and necessary templates.

• • Review of PMS data and conclusion derived by the manufacturer as per PMS plan. Unsatisfied reports; we will provide expert help to solve the issue.

• • Review of PMCF conclusion by the manufacturer. Incase of deficiency we provide expert help to solve the issue.

• • We also help in rewriting PMS and PMCF if required.

• • Review of risk-benefit ratio, residual risk, correlate with PMS and CAPA and design changes.

• • Special emphasis on review of custom made devices.

• • Check details in PSUR against estimate evaluation of the size and other characteristics of the population using the device.
• • Modification in PSUR based on rationale and description of any preventive and corrective actions taken against each risk and CAPA.

PSUR Case Study Presentation

Need help with Periodic Safety Update Report documentation including Data Analysis & Writing. Contact via below email.

PRICING

(Clinical Evaluation Report Writer, Consulting, Document & CER Writing Services with PMS, PMCF, PSUR)

Worried or confused about MDR Article 61 or MEDDEV 2.7/1 Revision 4 Clinical Evaluation Report?

No worries. We review your current clinical evaluation report, CER writing process from top to bottom by our expert writers.

If so, is it really necessary for the makeover to Article 61 we send you a formal offer for your approval.

Before we send the offer we take you to the cockpit and explain what we do and what you must do in due course.

CLINICAL EVALUATION REPORT		REGULAR	PREMIUM	ASSURED
		Class III $9999	Class III $11999	Class III $14999
		Class IIb $6999	Class IIb $9999	Class IIb $12999
		Class IIa $4999	Class IIa $7999	Class IIa $10999
STAGE 0Development of QMS Clinical Evaluation Process
	Scoping for Clinical Evaluation
	SOP Development for the Clinical Evaluation Activities
	Develop Clinical Evaluation Plan
	Guidance and Drafting Declaration of Interest
	Clinical Evaluator Profile and Selection Support
STAGE 1PHASE 1 – Identification of Pertinent Data
	Development of SOP for the Data Retrieval
	PHASE 2 – Data Generated and held by Manufacturer *
	Development of SOP for the Literature Search & Review
	Identify Literature Source and Scientific Literatures
	Search Report
STAGE 2Development of SOP for the Demonstration of Equivalence
	Demonstration for Equivalance Devices
	Development of SOP for the Appraisal of Clinical Data
	Data Suitability Appraisal
	Appraisal of Criteria for Data Contribution
STAGE 3Development of SOP for Analaysis of the Clinical Data
	Analysis of Clinical Data
STAGE 4Develop Clinical Evaluation Report with Conclusion
	Review Risk Benefit, IFU / User Manual, Pre-Clinical, Bench Test & Performance Test Data and make appropriate modification if needed
	PMS Guidance & Documentation
	PMCF Guidance and Documentation
	PSUR Guidance & Documentation
Cordination, Answering, making corrections in CER Writing and Resubmission to Notified Body till CER Approval.

Important things about CER Writing:

• Avaliablity of equivalent device 25% fees discount
• Drug Device combination products 40% additional fees
• Active Implantable Device 40% additional fees
• Additional Fess for paid scientific Literatures. The fees may vary between 150-350 USD
• Complete activities done in cloud. Consultants/Clinical writers travel to client located limited to emergency only.
• The above fees is for each clinical significance (Clinical Indication) of the medical device.
• We practice to complete a Class IIb CER writing for a single clinical indication in less than 120 days.

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