Clinical devices require thorough evaluation and quality checks before they are available in the market to bring up the follow-up. It includes adhering to the latest safety measures and ensuring the latest quality performance of the device in the market. This is where the concept of post market clinical follow-up comes into being and of immense help.
What Elements come under the PMCF plan?
The PMCF plan should detail the method specifying the method and process that the manufacturing team should follow to collect data for perfect evaluation.
- Confirm with latest safety tips and ensure quality performance of device enhancing its durability
- Identifying and working on previous side effects and trying to monitor them thoroughly, trying to minimize their impact on the present device
- Identify and try to work on the market risks of using the device
- Identify any misuse of the product by unauthorized means
What is Included in PMCF Plan?
The Post Market Clinical Follow-Up plan is a document that consists of the method for follow-up of examining medical devices. The document’s main purpose is for the regulatory purpose of device approval, and it is given after the device passes the quality check test. MDR submits the same and checks each device’s components, ensuring it is safe before it is available in the market for use. Other than this, the plan should include the following:
- Time-space of the activities of PMCF
- The primary objectives that PMCF mentions
- Standards that contribute to making the plan a successful one
- Correct examination of data relating to the device used for medical purposes
- Accurate appraisal of PMCF system and data analysis report about the use of the medical device
- The use of the general and useful specific method in PMCF plan for effective results
How to Frame a PMCF Plan?
When you want to pen down the plan, it should include two vital steps as below:
- System design First, it is important to plan its design that helps meet the requirement of the device before the plan is documented
- Plan structure – After the design, it is time for the structure, which is an important part of the PMCF plan as per MDR rules
What Data Should the Manufacturing Team offer as Part of Post Market Surveillance?
The main purpose for the new regulations of PMCF includes meeting the following by the manufacturing team:
- Improve the safety and reliability of using the medical device
- It should have transparency of information available for consumers using the device
- Enhance giving attention to details resulting in better market surveillance
However, in this regard, European Commission is bringing effective improvements to change the current trend. It includes how medical devices are made available in the market only after thorough quality checks and assuring quality service.
Do you know the Elements Included in PMCF Follow-up Plan?
The PMCF Guidance states the follow-up process elements that apply to all medical devices and their quality check. The follow-up process includes collecting and correct examination of the clinical data that states the correct state and performance of the medical device. The report should be maintained throughout the life of the device, checking its correct utility.
In this relation, one should know how medical device directive or MDD plays a vital role, and it has taken the importance of Post Market Clinical Follow-Up to the next level. It is applicable for all medical devices irrespective of their durability and risk. However, the medical device manufacturing team needs to understand the MDR framework states’ regulatory norms. Therefore, you can under the quality of a company depending on the quality of work and process it follows while manufacturing the devices.
What are the Major Objectives stated under PMCF Guidance?
As per the regulations of MDR, the objectives of PMCF are the detailed evaluation of a clinical device for correct use and checking its quality, meeting the highest performance standard. Other tips to follow are as follows:
- Identify and inspect risks in any device and its use
- Contribute to updates of clinical examination and adhere to its latest regulations, mainly for the manufacturing team
- Detect the chance of risks and know the hidden side effects in the device, if any
- Confirm the safety measures and utmost level of device performance before put to different medical use
- Try to find systematic misuse of the device and its impact on performance and others
The plan and evaluation reports hold equal importance in framing the system design and using it as a vital part of CER or clinical evaluation report of medical devices.
What Regulations to Follow in PMCF Regulations for Common Activities?
Device Registry by Manufacturing Team
At the time of device registry, it is essential to declare its group and type and its description and purpose to be used for. Depending on this, there would be a quality check as per data collected before it is put to use. The main purpose is to analyze the report based on data from different sources and check whether it meets the requirements.
Additionally, it should be at par with sufficient quality of the latest industry standards. However, the manufacturing team includes surveys from different healthcare sources to gather data and know the correct use of the device after evaluation and check for its quality.
What should PMCF Investigation Documents Include?
- CIP or Clinical Investigation Protocol would detail the steps how the study should take place for investigation
- The brochure specifies some responsibilities for investigators who are charged at every clinical-stage to give the suitable outcome of the evaluation
- Patients should get suitable information about the use of the medical device and its relevant consent document
What is Necessary to Develop Follow-up Plan?
The plan includes regulatory norms, clinical expertise, the familiarity of the manufacturing team with the latest industry rules and standards.
How PMCF Relates to Post-Market Surveillance or PMS?
The PMCF is a part of PMS, and each of it is dependent on others for ease of functioning. An effective medical device would work on collaborative data collection of both.
What Vitals to Include in PMCF Plan?
- A suitable method and correct evaluation of clinical data
- Method of PMCF that applies for correct device registration
- The objectives that PMCF needs to address
- Correct evaluation of clinical data
- Deciding the right schedule of PMCF activities that manufacturers should follow