2021 A Complete Guide on PMCF Evaluation Report

From April 2020, MDR (Medical Device Regulation) is officially stretched out by 1 year till May 2021.The EU MDGC (Medical Device Coordination group) has released 4 new guidance documents clinical investigations and evaluations.

Below 4 documents will help manufacturer to meet the MDR guidelines:Guidance on PMCF Evaluation Report Template

PMCF Evaluation Report will help manufacturers to compile their post market clinical follow up according to the new MDR requirements. With these manufacturers will be able to present their data in an organized manner making it easier for notified bodies and competent authorities to find the information.

The PMCF evaluation report template is defined in sections A through G.

A Section outlines Manufactures Contact Details

B Section outlines Medical device description and specification.

C Section provides a template for manufacturers to report all the activities defined in section C including activities performed, clinical data, justification of any deviations etc.

D Section outlines the evaluation of the clinical data related to equivalence of the medical devices with the similar one.

E Section requires detailed information defined in section D discussing with manufacturers about the results in section C and D that impacts the technical documentation of the CER.

F Section outlines the format to present the information on the devices in adherence to the guidance listed in the PMCF plan.

G Section outlines the conclusion that presents any need for preventive or corrective measures.

Guidance on Clinical Evaluation - Equivalence

The goal of this documentation is to detail the difference between the MEDDEV and the MDR when demonstrating equivalence. As per the new MDR technical, biological and clinical characteristics are important to demonstrate equivalence to another device. Each characteristic have little differences as below:

Technical Characteristics - MDR have pointed out some "software algorithms" for some specifications and properties for a medical device where MEDDEV have not.

Biological Characteristics - The MDR requires additional device information that are composed of substances or of combinations of substances that are intended to be introduced in the human body, absorbed by or locally dispersed.

Clinical Characteristics - As per MDR the device should have "same kind of user", which means any healthcare professional or lay person who uses the device.

Guidance on PMCF Plan Template

The aim of this document is to indicate the below information:

Device safety and performance through the device life cycle by the manufacturers

Identification on previously unknown side effects and monitor the identified side effects and contraindications by the manufacturer.

Identifying misuse and off label use of the device to identify that the intended purpose is correct

PMCF plan template is again broken into different sections and each section need different information as below:

A Section - Manufacturer Contact Details

B Section - Medical Device Description & Specification

C Section - PMCF related activities

D Section - Technical documentation references

E Section - Evaluation of clinical data related to equivalence and similar devices

F Section - references to specification, harmonized standard and guidance documentation

G Section - Estimated date of PMCF report

Guidance on sufficient clinical evidence for legacy devices

The objective of this document is to provide practical guidance on several scientific and clinical aspects that are relevant for conducting a clinical evaluation for legacy devices.

All clinical data from pre and post market phases need to identify properly and these include:

Clinical investigation reports of the device including PMS clinical data. Clinical investigation reports of the device, clinical investigation reports reported in scientific literature.

PMS Studies including post market clinical investigation reports, published in peer reviewed scientific literature on other clinical experience

Independent clinical studies may conduct using the device, other pre-market data for e.g. case report

Data retrieved from the literature

Again, MDR requires confirmation of conformity with the relevant GPRS to be based on clinical data.

Clinical Data Appraisal - Clinical data appraisal should be conducted using the verified and validated tools.

New Clinical Data Generation - New data need to be generate prior to CE marking under the MDR with sufficient clinical evidence to confirm safety and performance.

Clinical Data Analysis: This stage is just to determine the collection and analysis of data as per previous stage and demonstrate together conformity with relevant GSPR.

Bottom Line

Above guidance documents are necessary docs for manufacturers to follow MDR guidelines. Manufacturer for structured, organized and compliance data collection and management.