PMS & Vigilance

Post Market 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 the use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes.
PMS activities in the Company should be performed based on product-specific PMS plan. The purpose of the PMS plan is to serve as an organized scheduled system of planned yearly activities based on which PMS company procedures are performed.
According to EU MDR, PMS plan should be product specific and so you will need a separate plan for each product (or product category) in your portfolio. Medical devices of all classes need to have such a plan, the scope of which will differ based on product complexity and risks involved.
Designing a PMS plan and other PMS documentation is a time-consuming a, challenging task that requires a considerable amount of expertise.
BioReg Services experts can assess your PMS plan for compliance with MDR or write the plan from the scratch in harmony with the existing Company operating procedures.
Please get in touch with us if you need more info about the PMS plan or other services we can provide, including the writing of:

• PMS Plan
• PMCF Plan
• PMS report (Class I devices)
• PSUR (Class IIa, IIb and III devices)

In addition to defined internal PMS procedure, the companies should review the following regulations and guidance documents:

• EU MDR 2017/745 & EU IVDR 2017/746
• EN ISO13485: 2016
• 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

PMS should address the collection and utilization of available information, particularly:

• information concerning serious incidents, including information from Periodic Safety Update Reports (PSUR) and field safety corrective actions;
• records referring to non-serious incidents and data on any undesirable side-effects;
• information from trend reporting;
• Information from specialized or technical literature, databases and/or registries
• information, including feedback and complaints, provided by users, distributors, and importers;
• publicly available information about similar medical devices

PMS is carried out systematically and proactively by the manufacturer to collect and review experience gained from their devices on the quality, performance, and safety.

PMS aims to identify any need for determining, implementing and monitoring any preventive and corrective actions.
PMS is undertaken in accordance with a PMS plan, per Article 84
Article 83 of MDR sets out the requirements for PMS, including that PMS is an integral part of the manufacturers quality management system, per Article 10(9).

PMS System is expected to:

• Connect different process procedures describing the various elements of the PMS system;
• Define an update cycle that connects the various PMS activities and processes;
• Ensure that resulting documents represent associated data and reports in a consistent way;
• Determine a clear link to Post Market Clinical Follow-up (PCMF) activities defined in the PMCF plan;
• PSUR update for Class IIb + III devices should be done at least annually;
• PSUR update for Class IIa when necessary (by means when CER is updated) but at least every two years;
• PSUR of Class III and Implantable devices (IIa + IIb) shall be submitted to the Notified Body for review;
• The manufacturer of Class I devices should generate PMS report only

See our blog about MDR PMS here.

MDR Vigilance for Medical Devices

MDCG 2023-3 Questions and Answers published in February 2023 provide important info regarding the MDR Vigilance for Medical Devices as outlined in Section 2 of Chapter VII of the MDR.

Let’s start from the end and smack bang into the most crucial take-home advice. If you are an MDR manufacturer, you may need to update your company’s Vigilance procedure. Namely, many companies previously relied on MEDDEV 2/12-1 rev. 8, January 2013, which is, as guidance openly says (in the footnote, though), not applicable under the MDR anymore. In addition, there are some departures from ISO 14971:2019 (“use error”).

BioReg Summary

• The footnote info in this guidance is not less important than the info in the text, so don’t footloose it! Undoubtedly, the winner is: Guidelines on a Medical Devices Vigilance System, MEDDEV 2/12-1 rev. 8, January 2013 (applicable under the MDD), and AIMDD is not relevant anymore under the MDR (footnote 1), as we mentioned.
• Incidents (Article 2(64) MDR) are not reportable to competent authorities. Still, they must be documented, investigated, and reported (“Trend Reports” Article 88 MDR) to the competent authority(ies) of the Member State(s) in which the incidents occurred. The guidance still needs to clarify to whom to report if the incidents occurred in different Member States.
• If you cannot exclude that the incident could potentially have led to the “serious incident,” the incident must be considered serious.
• The manufacturer must report serious incidents to the relevant competent authority using the Manufacturer Incident Report (MIR), within the timelines outlined in Article 87(3) to (5) MDR: Any serious incident (no later than 15 calendar days); A serious public health threat (no later than 2 calendar days); Death or an unanticipated serious deterioration in a person’s state of health (no later than 10 calendar days).
• Expected undesirable side effects must be reported under the requirements for trend reporting (Article 88 MDR). This emphasizes the importance of carefully defining product’ expected undesirable side effects in the risk analysis.
• Suppose the manufacturer cannot demonstrate that a potentially serious incident is an expected undesirable side-effect within the deadlines set out in Article 87(3) to (5) MDR. In that case, it must submit a Manufacturer Incident report (MIR) within the reporting timelines.

BioReg Services

Please don’t hesitate to contact us if you need any help writing PMS or Vigilance documentation or have any other questions on MDR Compliance.