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In 2023-2024, IGJ performed PMS inspections on 13 manufacturers, primarily micro, small, and medium-sized enterprises, covering Class I medical devices, software applications, and in-vitro diagnostics (IVDs) that are being marketed as legacy devices. It was indicated that two-thirds of the inspected devices were to be “up-classified” and subject to Notified Body certification by the end of the MDR / IVDR transition period.

PMS inspections were limited to evaluating the PMS Plan and PMS Report or Periodic Safety Update Report (PSUR), and the integration of these documents into the manufacturer’s Quality Management System (QMS). The findings were published in the document “Call to medical device manufacturers: implement an effective PMS system”, which are presented below.

• None of the 13 assessed manufacturers fully complied with their MDR / IVDR PMS obligations, despite certified QMS systems having been implemented.
• A PMS Plan was absent or had non-conformities (esp. information deficiencies) in >50% of cases
• PMS Reports / PSURs had non-conformities (esp. data quality deficiencies) in ~50% of cases

PMS Plan
• Applicable devices / devices in scope not specified
• Required information missing / plans too generic

PMS Reports / PSURs
• Procedure for proactive and systematic acquisition of PMS information lacking
• Ambiguous and uninformative presentation of data (e.g. incidents & severity)
• Inclusion of irrelevant information / data
• No thresholds defined for triggering follow-up actions /document updates
• Lack of conclusions, including on benefit-risk impacts
• Lack of follow-up actions to improve marketed product
• Specified PMS Report / PSUR update procedures were not followed as indicated in the PMS Plan
• Specified clinical / performance evaluation update procedures based on PMS findings were not followed

• IGJ expects broader, structural improvement of processes at manufacturers, including consideration of a soon to be published EU PMS guidance document.
• IGJ will maintain its supervision of manufacturers regarding this topic and incorporate it into routine inspections.
• The IGJ also indicated that will also take up this issue of PMS non-compliance internationally and at a policymaking level. Previous publications on this topic from Swissmedic and the IJG (see OTHER PMS NON-COMPLIANCE NOTICES FROM INSPECTING AUTHORITIES section below) will add weight to the need for more stringent oversight and / or enforcement of manufacturer compliance with MDR and IVDR post-market obligations.

• Swissmedic in Q1 / 2023 (18 months after implementation of MDR post-market obligations) published similar findings on implementation of MDR PMS obligations. Of 27 class I device manufacturers inspected, 70% of PMS documentation did not meet MDR requirements. The majority of non-conformities concerned data collection and the evaluation of (serious) incidents and trends. Consequently, a dedicated Medical Devices Surveillance Sector was established in January 2024.

• In January 2023, IGJ published the results of a survey on the status of IVD manufacturers PMS implementation (six months after the implementation of IVDR post-market obligations). Out of 43 manufacturers representing 150 Class B-D IVDs, 30% of manufacturers admitted that their implemented PMS framework still did not fully comply with IVDR PMS requirements (PMS system, PMS plan and PMPF plan). This triggered the development of an assessment framework (only in Dutch) and application in the 13 inspections that provided the results presented above.

Competent Authorities have various mechanisms to address non-compliance. For the IGJ this is defined in their intervention policy (in Dutch only), based on MDR (Art94, 95, 97, 98), IVDR (Art 89, 90, 92, 93) and national regulations, as applicable.
This is applied when a medical device:

• Shows one or more non-conformities and poses an unacceptable risk;
• Shows one or more non-conformities but not an unacceptable risk;
• Poses a potential risk.

In addition to manufacturers being required to take all appropriate measures and corrective actions necessary to restore compliance and eliminate risks, the IGJ can:

• Apply a warning
• Apply a fine
• Prohibit or restrict the placing on the market of the device
• Subject the placing of the device on the market to specific requirements
• Recall the device
• Withdraw the device from the market

Manufacturers should proactively and critically assess their PMS processes and documentation for compliance with PMS obligations stated in the MDR / IVDR. This may include:

1. Internal (re-)assessment: Assess the current PMS system against MDR / IVDR requirements and MDCG guidances for gaps and remediate any deficiencies. (This should include assessment against the impending MDCG “Guidance on Post-Market Surveillance” when released).
2. Documentation remediation: For identified documentation deficiencies, remediate with implementation of appropriate measure, such as aspects described in the ISO technical report (ISO/TR 20416) on Medical devices – Post-market surveillance for manufacturers, and the WHO Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
3. External review: Have an external PMS regulatory expert review and / or remediate and develop PMS technical documentation to ensure your organisations PMS activities meet currently accepted expectations within the field. Consider mock audits to assess adequacy of processes.
4. Compliance Training: Provide regular training of employees on relevant and updated MDR/IVDR regulations, guidances, and compliance protocols.
5. Proactive action: Ensure appropriate intervals for assess of various data sources to demonstrate continuous and systematic surveillance that facilitates timely identification of incidents, and implementation of CAPAs. Consider implications of new PMS data on user documentation, risks management and clinical evaluation in initiating, preparing, and completing PMS reports.

Unsure where to start? Request a call to discuss how AARQK consulting can support your PMS compliance activities.