To achieve the purpose of the manufacturer’s PMS system, the manufacturer must have a PMS plan. This is also stated in Article 84 of the MDR. But article 84 basically only references Annex III, which is the annex that describes the requirements on the technical documentation of the PMS.
Annex III states that PMS activities shall be part of the manufacturers’ technical documentation. Then in turn, the technical documentation shall cover articles 83–86 which are the articles containing the requirements for the PMS system, PMS plan, PMS report and PSUR (where applicable). This technical documentation must be clear, organised, readily searchable and set up in an unambiguous manner.
How to collect and utilise data
The PMS plan must specify how to collect and utilise available intelligence, in particular more specific information and data.
Medical device PMS plan contents
- A proactive and systematic process to collect any information in the “PMS Plan information sources” column.
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 system
- Effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field
- Methods and protocols to manage the incidents subject to the trend report as provided for in Article 88, 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 QMS procedures to fulfil the manufacturers obligations laid down in Articles 83 (PMS system), 84 (PMS plan) and 86 (PSUR)
- Systematic procedures to identify and initiate appropriate measures including corrective actions (and preventive actions)
- Effective tools to trace and identify devices for which corrective actions (or preventive actions) might be necessary
- A PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
A process to collect information
According to the MDR, the PMS plan needs to cover how to proactively and systematic collect any information from the sources specified in the plan. This plan shall stipulate the relevant and correct characterisation of the performance of the devices in the scope of the PMS and how to stipulate the criteria to deem similar devices on the market to be comparable to the manufacturer’s devices.
Medical device PMS plan information sources
- Information concerning serious incidents, including information from PSURs, and field safety corrective actions
- Records referring to non-serious incidents and data on any undesirable side-effects
- Information from trend reporting
- Relevant specialist or technical literature, databases and/or registers
- Information, including feedbacks and complaints, provided by users, distributors and importers
- Publicly available information about similar medical devices
Descriptions of methods to assess collected data
Furthermore, the PMS plan needs to include a description of appropriate methods to effectively assess the collected information and data. Then, there shall be suitable indicators and threshold values for continuous reassessment of the benefit-risk analysis and potential improvements to the risk management system.
Each manufacturer shall have, in their risk management plan, criteria stipulated to assess the overall residual risks with their devices. This residual risk must not outweigh the clinical benefits of using the device.
Linking the PMS plan and the risk management plan
This means that the PMS plan needs to state how to collect and assess the clinical data for the use of the device to assure that the benefit-risk analysis is still relevant. So, the PMS plan needs to be linked to the risk management plan both for the risk-benefit analysis but also for when updates of the whole risk management process are needed.
Methods and tools to investigate complaints
A more tangible requirement that the PMS plan needs to cover is to set up appropriate methods and tools for how to effectively investigate complaints and analyse other relevant market-related experience.
Methods and criteria for trend data
Methods and protocols shall be set up to manage the events subject to the trend report as provided for in Article 88. Those events are incidents that are not deemed as reportable events under the vigilance system. The PMS shall also have methods and protocols to set up criteria for when the trend data indicates statistically significant increases in the frequency or severity of those incidents.
The PMS plan must also include how to communicate effectively with competent authorities, notified bodies, economic operators and users.
References to procedures in the QMS
The next thing that the PMS plan needs to include is references to the procedures in the manufacturers’ QMS on how their PMS system works – the procedures for how to set up the PMS plan and how to set up and manage the PMS report or PSUR. This could for example be references to the corrective actions and preventive action processes.
Reference to the PMCF-plan
Finally, the last requirement that the PMS plan needs to consider is a reference to the PMCF plan or a well-supported justification as to why PMCF is not applicable. The PMCF plan requirements are found in Annex XIV.
If the manufacturer states that PMCF is not applicable, this must be thoroughly explained. This is not recommended because most medical devices will have clinical data and trying to explain why not to include it is very difficult.
There are medical devices for which PMCF can be exempt, for example, sterilisation equipment or other cleaning devices.
Would you like to know more about the Medical Device Regulation?
If you want to know more about understanding the European regulation for medical devices, take a look at our online Introduction to the Medical Device Regulation (EU) 2017/745 course. This online course is an in-depth overview of the Medical Device Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.
It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.