In this post, we will try to summarize all you have to know in order to design Post Marketing Surveillance – PMS and Post Marketing Clinical Follow Up – PMCF plan for your medical device in compliance with the new EU medical device regulations – MDR.
Let’s start from the basics and try to understand what these two quality documents: post marketing surveillance plan and PMCF plan are all about and how to design them efficiently.
What are PMS and PMCF – Definitions
Post Marketing Surveillance – PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes.
Post Marketing Clinical Follow Up – PMCF is a continuous process that updates the clinical evaluation which is the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.
If required, PMCF plan will be included within the manufacturer’s PMS plan.
What Do I Need PMS and PMCF Plan For?
The purpose of PMS and PMCF plan is to serve as an organized scheduled system of planned yearly activities based on which PMS and PMCF company procedures are performed.
According to EU MDR, PMS and PMCF plan are product specific and so you will need a separate plan for each product in your portfolio. Medical devices of all classes need to have such plan, the scope of which will differ based on product complexity and risks involved.
Usually, CEO or other management representative will have the overall responsibility for designing and implementation of PMS and PMCF plans.
In addition to defined company PMS and PMCF procedures, you will need to review the following regulations and guidance documents:
- New EU MDR 2017/745 on medical devices from 5 April 2017
- EN ISO13485: 2012 clauses 8.2.1 and 8.5.1
- MEDDEV 2.12/1 Rev. 8, Medical devices vigilance systems
- MEDDEV 2.7/1 Rev. 4, Clinical evaluations
- MEDDEV 2.12/2 Rev. 2, Guidelines on Post Market Clinical follow up (PMCF)
- PMS Sources NBMED 2.12 rec 1
Is Your Post Market Surveillance Plan in Compliance with the New MDR Requirements?
According to new medical device regulations published in April, 2017, post market surveillance plan shall address the collection and utilization of available information, in particular:
- information concerning serious incidents, including information from Periodic Safety Update Reports – PSURs, and field safety corrective actions;
- records referring to non-serious incidents and data on any undesirable side-effects;
- information from trend reporting (a reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred and for which pre-defined trigger levels are used to determine the threshold for reporting); relevant specialist or technical literature, databases and/or registers;
- information, including feedbacks and complaints, provided by users, distributors and importers;
- and publicly available information about similar medical devices.
The post market surveillance plan shall cover at least:
- a proactive and systematic process to collect any required information. The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
- effective and appropriate methods and processes to assess the collected data;
- suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- risk analysis and of the risk management;
- effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
- methods and protocols to manage the events subject to the trend report, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
- methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
- reference to procedures to fulfil the manufacturers obligations for PMS system, PMS plan and PSUR;
- systematic procedures to identify and initiate appropriate measures including corrective actions;
- effective tools to trace and identify devices for which corrective actions might be necessary; and
- a PMCF plan or a justification as to why a PMCF is not applicable.
Post-Market Clinical Follow Up Plan – Content and Requirements
PMCF is a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer’s post market surveillance plan.
When conducting PMCF, the manufacturer should proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:
- confirming the safety and performance of the device throughout its expected lifetime,
- identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
- identifying and analysing emergent risks on the basis of factual evidence,
- ensuring the continued acceptability of the benefit-risk ratio, and
- identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
The PMCF plan shall include at least:
- the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
- the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
- a rationale for the appropriateness of the methods and procedures used;
- a reference to the relevant parts of the clinical evaluation report and to the risk management;
- the specific objectives to be addressed by the PMCF;
- an evaluation of the clinical data relating to equivalent or similar devices;
- reference to any relevant harmonized standards used by the manufacturer, and relevant guidance on PMCF; and
- a detailed and adequately justified time schedule for PMCF activities to be undertaken by the manufacturer.
The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.
The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation and in the risk management. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
Designing a PMS and PMCF plan compliant to aforementioned requirements is a time-consuming a challenging task which requires a considerable amount of expertise.
BioReg Services will be happy to assess your PMS & PMCF plans for the compliance with MDR or write them from the scratch in accordance and in harmony with the existing company operating procedures.