When talking about Gap Analysis in medical devices, the conversation usually goes straight to the technical file, the QMS (Quality Management System), or clinical evaluation. However, in practice, one of the biggest compliance bottlenecks does not arise before going to market, but after. What is critical is how the manufacturer demonstrates that its Post-Market Surveillance (PMS) system is live, proportional to risk, and feeds real decisions (risk management, CAPA, clinical/performance evaluation, etc.).

The MDCG 2025-10 guidance itself insists that PMS is a continuous process throughout the life of the device and that, after establishing the initial plan, it must be maintained and updated with real market data. The problem is that many organizations do not have a PMS that can withstand a rigorous review.

That is why, in this article, we explain why a specific PMS Gap Analysis can make all the difference. It is not about reviewing a document, but about checking whether the system is capable of generating solid and coherent evidence, without internal contradictions, and with a clear common thread.

Why PMS has become the critical point

Hay dos razones principales por las que PMS está ganando protagonismo.

La primera razón es regulatoria y operativa: El MDR (Reglamento de Dispositivos Médicos) y el IVDR (Reglamento sobre Diagnóstico In Vitro) aumentan el número de entregables post-market y la necesidad de alinearlos. En IVDR, por ejemplo, se multiplican documentos que repiten información básica (descripción, indicaciones, warnings) en PMS Plan, PSUR (Informe Periódico de Seguridad Actualizado), planes e informes de seguimiento post-market, y documentación de evaluación de performance.

Esto genera una carga administrativa enorme y, sobre todo, incrementa el riesgo de inconsistencias internas. MedTech Europe lo describe precisamente como un foco de “alineación difícil” entre documentos clínicos y post-market, con duplicidades que penalizan recursos y tiempos. 

La segunda razón es práctica: en muchas experiencias de mercado, los Organismos Notificados piden evidencias PMS muy concretas, y las organizaciones se encuentran con que los documentos no encajan entre sí. Un ejemplo recurrente en el sector es el “efecto dominó” entre PSUR y SSCP (Systems Security Certified Practitioner): si el SSCP depende de conclusiones del PSUR, exigirlos en paralelo complica plazos y provoca iteraciones. Este tipo de fricciones está recogido como problemática en informes sectoriales. 

En este contexto, un Gap Analysis que se centre en PMS no “repite” el enfoque general: lo amplía en un área donde hoy se están jugando tiempos de revisión, rondas de preguntas y, en consecuencia, time-to-market.

There are two main reasons why PMS is gaining prominence:

The first reason is regulatory and operational: The MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostic Regulation) increase the number of post-market deliverables and the need to align them. In IVDR, for example, documents that repeat basic information (description, indications, warnings) multiply across the PMS Plan, PSUR (Periodic Safety Update Report), post-market performance follow-up plans and reports, and performance evaluation documentation.

This generates a massive administrative burden and, above all, increases the risk of internal inconsistencies. MedTech Europe describes this precisely as a focus of "difficult alignment" between clinical and post-market documents, with duplications that penalize resources and timelines.

The second reason is practical: In many market experiences, Notified Bodies ask for very specific PMS evidence, and organizations find that their documents do not fit together. A recurring example in the sector is the "domino effect" between PSUR and SSCP (Summary of Safety and Clinical Performance): if the SSCP depends on PSUR conclusions, requesting them in parallel complicates deadlines and causes iterations. These types of friction are documented as industry-wide issues.

In this context, a Gap Analysis focused on PMS does not "repeat" the general approach: it expands it into an area where review times, question rounds, and consequently, time-to-market are currently at stake.

What a PMS Gap Analysis reviews

La guía MDCG 2025-10 deja algo muy claro: el PMS no es un apéndice, es un sistema integrado en el QMS, y su documentación clave incluye como mínimo el PMS Plan y los informes (PMS Report o PSUR, según aplique). Un Gap Analysis orientado a PMS se enfoca, sobre todo, en responder a preguntas de “realidad operativa”, no solo de “existencia documental”.

Primero, el PMS Plan.

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The MDCG 2025-10 guidance makes one thing very clear: PMS is not an appendix, it is an integrated system within the QMS, and its key documentation includes, at a minimum, the PMS Plan and reports (PMS Report or PSUR, as applicable). A PMS-oriented Gap Analysis focuses primarily on answering questions of "operational reality," not just "documentary existence."

First, the PMS Plan.

In MDR/IVDR, PMS must be based on a plan that forms part of the technical documentation (with nuances for custom-made devices under MDR), and that plan must define what is monitored, how often, using what methods, and with what justification based on the risk profile.

Here, the typical gap is not "there is no plan," but "the plan is generic": it is not clear what data will actually be collected, who collects it, how trends are detected, or what thresholds trigger a benefit-risk re-evaluation or corrective action.

Next, consistency between outputs.

PMS Report/PSUR. The guidance explains that post-market documentation includes reports and that PMS feeds technical documentation updates, risk management, and clinical/performance evaluation.

When these are not connected, gaps emerge such as:

  • PSUR that is not reflected in risk management
  • Market signals that do not end up in CAPA
  • Literature mentioned "in passing" without traceable impact on conclusions

And finally, the "closed loop."

An effective PMS demonstrates a continuous cycle: information is gathered, analyzed, decisions are made, actions are taken, and documentation is updated. It even emphasizes that PMS effectiveness must escalate to management (for example, via management review).

If that loop is not evidenced with records and decisions, the PMS remains purely theoretical.

The big mistake: thinking PMS is an “annual document”

A quick way to detect gaps is to look at how the calendar is managed. Many organizations treat PMS as something that is "updated" once a year, but the MDCG 2025-10 approach goes in the opposite direction: PMS is continuous, and the plan defines frequency and methods according to risk.

This is especially delicate when the product undergoes frequent changes (families, variants, software, labeling updates). If there is no clear mechanism to capture the post-market impact of changes, PMS becomes retrospective and reactive—precisely what penalizes a review most.

How a PMS Gap Analysis is structured to deliver real value

In practice, an effective approach relies on three layers:

1. First layer: scope and document map.

It identifies which post-market documents apply to the device (MDR or IVDR, class, family, markets) and how they relate to each other: PMS Plan, PMSR/PSUR, PMCF/PMPF when applicable, and associated outputs (trends, complaints, vigilance, FSCAs). The MDCG 2025-10 guidance offers precisely a high-level view of this system and its associated documentation. 

2. Second layer: execution evidence.

Here, it does not audit "whether a procedure exists," but whether there is proof that it works: complaint analysis records, trend reports, meetings, decisions, CAPAs, and derived updates. This part is usually the biggest value driver because it uncovers "silent gaps": processes that are perfect on paper but generate no traceability in execution.

3. Third layer: consistency and alignment.

In sectors with heavy documentation, the real risk is contradiction: a PSUR conclusion that does not fit the SSCP, a PMS Plan that describes different indicators than those used, or a clinical/performance evaluation that does not incorporate post-market signals. The sector itself points to the burden and complexity of keeping many aligned documents as a major pain point.

 

Conclusion: PMS is where regulatory maturity is proven

A general Gap Analysis tells you "what is missing." A PMS Gap Analysis tells you something far more valuable: whether your organization has a system capable of sustaining compliance over time, not just "taking a snapshot" of the technical file.

Furthermore, this is a topic with scope for a series: you can later publish specific pieces on PSUR, PMCF/PMPF, or how to align PMS with risk management without duplicating work (highly demanded by RA/QA teams).

This approach fits perfectly as a variant of your Gap Analysis service (MDR/IVDR), framing it as a specific "PMS readiness" module within the diagnostic.

At Ambit Iberia, we have been experts for over 20 years in developing IT strategies and solutions. We help the pharmaceutical, medical device, and IVD (in vitro diagnostics) sectors comply with regulations throughout the entire product lifecycle. We design and implement innovative infrastructures leveraging a global service offering as a key driver for digital transformation.

If you want to know more about this or another solution, contact us.