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PMS Planning and Challenges under EU MDR

PMS Planning and Challenges under EU MDR

October 15, 2020 EU MDR

While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device Directive (MDD), it was not defined clearly in the MDD. Lack of clarity is completely removed with the publication of the new EU MDR. Not only is PMS defined in Article 2 (60), it is listed as one of the general obligations of all manufacturers (new Article 10). It is also one of the topics specifically called out for monitoring by the person responsible for regulatory compliance (new Article 15).

Post Market Surveillance, as described in EU MDR Medical Device Regulation, is a new concept. A manufacturer shall know at all times how his product performs in the field.For each device, manufacturer shall establish a post market surveillance system (PMS system).

The PMS system has to allow:

  • Arrow systematic and active gathering of information;
  • Arrow cooperation with the competent authorities responsible for vigilance and market surveillance;
  • Arrow connection with the system for corrective action or preventive action to incorporate lessons learned; and,
  • Arrow update of the technical documentation, including the risk-benefit determination and clinical evaluation

This system shall be an integral part of the manufacturer’s QMS and shall be based on a post market surveillance plan (PMS plan). The requirements of the post market surveillance plan are set out in Annex III. 1.1. That PMS plan shall be part of the technical documentation. Mainly, the PMS system shall be a proactive process and shall be constantly updated. (Article 83 & 84).

Clinical Development Plan

Post-market surveillance plan requirements

Under the Regulations, a PMS plan has to be established for each device or device family. Potential information for use in PMS comes from a number of sources, including:

  • Arrow investigations of serious incidents, investigations of incidents not meeting the criteria for classification as serious incidents, data on undesirable side effects;
  • Arrow trend analysis and reporting;
  • Arrow field safety corrective actions;
  • Arrow reports in specialist or technical literature;
  • Arrow reports or outputs from databases or registries;
  • Arrow complaints provided by users, distributors and importers;
  • Arrow other feedback including customer surveys, information provided as input into manufacturer’s websites and reports in social media; and,
  • Arrow publicly available data on events with similar devices provided by other manufacturers.

PMS plan includes a description of indicators and thresholds for continuous reassessment of risk management and the risk-benefit analysis together with the means to:

  • Arrow investigate complaints and market experience from the field;
  • Arrow monitor trends, identify statistically significant increases in frequency or severity of incidents and provide trend reports;
  • Arrow communicate with competent authorities and notified bodies;
  • Arrow communicate with authorized representatives, importers, distributors, users and patients;
  • Arrow trace and identify devices for which correction or corrective action might be necessary;

The PMS plan should also reference the documented procedures describing i) the PMS system, ii) the creation of the PMS and PMCF Plan, iii) the generation of the PSUR or PMS report, as applicable; and, iv) the processes for identification and implementation of corrections, corrective actions or preventive actions. The PMS plan is an element of the technical documentation and so needs to be in place before the Declaration of Conformity to the applicable Regulation is drawn up and before the device can be CE marked under the Regulations.

Proactive Reactive
Customer surveys Customer complaints
Post CE mark clinical trials , including PMCF Unsolicited user feedback (other than complaints)
Manufacturer sponsored device tracking/implant registries Maintenance/service reports
Expert user groups (focus groups) Trend analysis
Market Actions (FSNs) Failure analysis
Adverse event reports Social media
  Literature reviews

The Regulations contain new requirements to prepare summary reports of PMS information for all classes of devices.

Class I Class IIa Class IIb Class III Implantable
PMSR PSUR | throughout the lifetime of the device | PMCF
As necessary As necessary or every 2 years As necessary or annually at a minimum
Available to the Notified Body (NB) Submitted to NB via EUDAMED
Available to Competent Authority upon request of Notified Body Made available to Competent Authority via Electronic filing EUDAMED

Some Challenges

  • Arrow As PMCF plan to be part of PMS plan, currently organizations do these independently and PMS (or Quaity teams) are siloed from Clinical teams in some companies. As PMS team needs to sign off the PMS plan, dependency or alignment with Clinical is important going forward
  • Arrow One of the newer requirements is Literature Search. Most PMS teams neither have processes nor teams to do this activity. Teams need to plan on what and how to do the Literature part
  • Arrow The design of a quality management system which is conducive to the potential of multiple updates to processes, technical documents and even devices themselves.
  • Arrow Establishment of suitable indicators and threshold values that shall be used in the continues reassessmentof the benefit risk analysis and of the risk management.
  • Arrow Establishment of effective and appropriate procedures describing PMS system, PMS plan, PMCF plan, CAPA, trend investigation.

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EU MDR