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.
The PMS plan must specify how to collect and utilise available intelligence, in particular more specific information and data.
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.
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.
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.
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 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.
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.
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.
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.
Receive FREE templates and quarterly updates on upcoming courses that can help you in your career! Subscribe to our newsletter now.
When you submit this form, you will be sending personal information to medicaldevicehq.com. To comply with GDPR requirements, we need your consent to store and use the personal data you submit. Take a look at our Privacy policy for more details.
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.
