Medical Device Regulation – MDR and PMS

Medical Device Regulation – MDR and PMS Requirements

This article clarifies the primary post-market surveillance (PMS) elements and requirements according to Medical Device Regulation (MDR).

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 a product-specific PMS plan.

The Purpose of the PMS (MDR) Plan

PMS plan aims to serve as an organized, scheduled system of planned yearly activities based on PMS company procedures.

According to EU MDR, the PMS plan should be product-specific, 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.

Usually, the CEO, Marketing Manager, and Person Responsible for Regulatory Compliance (PRRC) will be responsible for designing and implementing the PMS plan.

In addition to the defined company PMS procedure, you will need to review the following regulations and guidance documents:

• EU MDR 2017/745 & EU IVDR 2017/746
• 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 2.7.1 Rev.4
• MEDDEV 2.12/2 Rev. 2, Guidelines on Post-Market Clinical follow up (PMCF)
• PMS Sources NBMED 2.12 rec 1

PMS Activities

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

What is the difference between Vigilance and PMS?

Vigilance is a reactive process that includes reporting serious incidents and field safety corrective actions by manufacturers to the relevant competent authorities. In addition, manufacturers also have to report trends in expected undesirable side effects and incidents that are not classified as serious. The vigilance requirements are described in Article 87 of MDR, which include timescales for reporting depending on the severity of the serious incident.

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

• PMS aims to identify any need for determining, implementing, and monitoring any preventive and corrective actions.
• PMS is undertaken by 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 manufacturer’s quality management system, per Article 10(9).

The Content of PMS Plan

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 characterization 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 analyze market-related experience collected in the field;
• methods and protocols to manage events subject to trend report, including the methods and protocols used to establish 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 fulfill the manufacturers’ obligations for PMS system, PMS plan, and Periodic Safety Update Report (PSUR);
• systematic procedures to identify and initiate appropriate measures including corrective actions;
• practical tools to trace and identify devices for which corrective actions might be necessary; and
• a Post-market Clinical Follow-up (PMCF) plan or a justification for why a PMCF is not applicable.

 

Technical documentation on PMS

For Technical documentation on Post Market Surveillance (PMS) you should review EU MDR 2017/745 (Annex III). This documentation includes:

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

The presentation of these documents and all Technical Documentation in general, should be clear, organized, readily searchable, and unambiguous.

Difference between PSUR and PMS Report

• 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

Best PMS practice for data collection & review procedures

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

Frequently Asked Questions

Question: I searched for the UDIs for medical devices approved under MDR in Eudamed. Unfortunately, many products have no UDIs registered yet. Could you please explain what is the reason for this?

Answer: A Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED is published on 24 January 2024. The new proposal aims to enable the gradual implementation of individual EUDAMED modules once they have been audited and declared functional. This replaces a concept where EUDAMED is mandatory only after all modules (including Clinical investigations/Performance studies, which are delayed) become fully functional—which, according to this, would be required only in 2029. According to this new proposal, mandatory use of several modules could then start as early as Q4 2025. Meanwhile, they are voluntary.

Question: Does the Importer of MDR medical device need to handle the payables and other accounting in order to be compliant?

Answer: No, the Importer of device under MDR is not required to handle financial payables or accounting to be compliant. The MDR defines the importer role strictly in terms of regulatory responsibilities, not commercial functions like payments. Financial transactions (e.g., payments to suppliers) can be managed by distributors, agents, or the manufacturer without impacting MDR compliance.

Question: Can the manufacturer have more than one Importer of the medical device within the EU?

Answer: Yes, a manufacturer can designate multiple Importers within the EU. This is common for companies with complex distribution networks across different EU countries. Each importer must fulfill the full MDR obligations for the products they import. It’s advisable to have Manufacturer – Importer Agreement to clearly define responsibilities and avoid gaps in compliance.

Question: Can manufacturer use a sticker label on the product to add importer information?

Answer: Yes, MDR allows the use of sticker labels to indicate importer information (unless this is Class III/High-Risk device). The sticker should be permanently affixed to the product packaging or accompanying documentation. In addition, the sticker should be legible, durable, and compliant with MDR labeling rules.

PMS MDR requirements should be clearly understood. Designing a PMS plan and other PMS documentation is a time-consuming and challenging task requiring considerable expertise. BioReg Services experts can assess your PMS plan for compliance with MDR or write a new plan in harmony with the existing company operating procedures.

For specific questions on this or any other topic, don’t hesitate to contact me directly at daniel.albahari@bioregservices.com

BioRegards,

Daniel