Swissmedic 2026 PMS Focus Campaign: What Class IIa/IIb/III Manufacturers Must Prepare Now

Swissmedic Is Coming for Your PMS Documentation

On April 23, 2026, Swissmedic — Switzerland's federal authority for therapeutic products — announced a new focus campaign targeting post-market surveillance (PMS) documentation for higher-risk medical devices on the Swiss market. The campaign will randomly select Class IIa, IIb, and III devices and request comprehensive PMS records from their manufacturers or Swiss Authorized Representatives (CHREP).

This is not a theoretical exercise. Swissmedic ran a similar campaign in 2024 and the findings were sobering: full compliance with PMS obligations remains a challenge for many manufacturers. The 2026 campaign signals that Swissmedic is not satisfied with the status quo and intends to keep the pressure on.

For manufacturers placing Class IIa, IIb, or III devices on the Swiss market, the message is unambiguous: your PMS system must be real, current, and documentable. If Swissmedic selects your device, you will need to produce evidence that your post-market surveillance is not a paper exercise but a functioning, data-driven process that feeds back into your risk management and design cycles.

This article breaks down what the campaign covers, what Swissmedic will look for, what the 2024 campaign found, and what manufacturers should do right now to prepare.

Background: Swiss MedDO Post-Market Surveillance Requirements

Switzerland's Medical Device Ordinance (MedDO, SR 812.213) implements the regulatory framework for medical devices placed on the Swiss market. Since the Mutual Recognition Agreement (MRA) between Switzerland and the EU was not updated to cover MDR, Switzerland enacted MedDO to maintain regulatory alignment with EU MDR 2017/745. The PMS provisions in MedDO's Chapter 7 ("Device Surveillance") closely mirror those in EU MDR Chapter VII — and in several cases, MedDO directly references specific MDR articles and annexes as the operative legal text.

Three key articles form the backbone of PMS obligations under MedDO:

Article 56 MedDO — Post-Market Surveillance System

Article 56 requires manufacturers of Class I, IIa, IIb, and III devices to establish and maintain a post-market surveillance system. This system must be proportionate to the risk class and appropriate for the device type. The PMS system is not optional and is not a one-time setup — it must be continuously updated throughout the device's lifetime on the market.

The PMS system must collect, record, and analyze data from multiple sources: clinical investigations, vigilance reports, complaint data, literature reviews, user feedback, and any other relevant post-market information. The goal is to enable manufacturers to identify risks, verify that the benefit-risk balance remains acceptable, and detect emerging safety issues early.

Article 58 MedDO — Post-Market Surveillance Plan

Article 58 requires manufacturers to establish a PMS plan for each device (or device group). The plan must describe how PMS data will be collected, the methods used, the frequency of data collection and analysis, and how results feed into the risk management file and clinical evaluation.

A PMS plan is not a static document. It must be reviewed and updated at documented intervals, particularly when new risk information emerges, when the intended use changes, or when the device undergoes significant modifications.

Articles 60-61 MedDO — Periodic Safety Update Reports (PSURs)

Articles 60 and 61 require manufacturers to document the results of their PMS activities in safety reports. For Class IIa devices, these reports must be produced and made available to the competent authority upon request. For Class IIb and III devices, the reports take the form of Periodic Safety Update Reports (PSURs), which must be produced at least annually for both Class IIb and Class III, unless a different frequency is justified. (It is Class IIa devices whose safety reports must be updated at least every two years.)

PSURs must summarize the results and conclusions of the PMS data analysis, the volume of sales, an estimate of the population using the device, and a rationale for any corrective actions taken. For Class III and implantable Class IIb devices, the PSUR is part of the technical documentation reviewed by the notified body.

Summary of Key MedDO PMS Articles

MedDO's Direct References to EU MDR Provisions

An important nuance that many manufacturers overlook: MedDO does not merely parallel the EU MDR PMS requirements — in several cases it explicitly incorporates them by reference. Specifically:

• Art. 56 MedDO operates in combination with Art. 83 MDR (post-market surveillance system)
• Art. 58 MedDO operates in combination with Annex III Paragraph 1 MDR (PMS plan content requirements)
• Art. 60-61 MedDO operates in combination with Annex III Paragraph 2 MDR (safety report and PSUR content requirements)

This means that when Swissmedic assesses your PMS documentation, they are effectively evaluating compliance against both MedDO and the corresponding MDR provisions. Manufacturers should ensure their documentation addresses the requirements in both texts. Swissmedic's 2024 campaign report explicitly cited this combined legal basis when documenting non-conformities.

Terminology Note: Designated Body vs. Notified Body

One practical difference worth noting: Swiss legislation uses the term "designated body" rather than "notified body." The designated bodies have the same remit as EU Notified Bodies, and for all practical purposes the roles are equivalent. However, if you see "designated body" in Swissmedic correspondence or Swiss regulatory documents, it refers to the conformity assessment body — not a different entity.

SSCP Requirements Under MedDO

For Class III devices and implantable devices, MedDO also requires a Summary of Safety and Clinical Performance (SSCP) — mirroring the EU MDR requirement. The SSCP must be submitted to the designated body for validation. However, there is a key difference from the EU: in Switzerland, the manufacturer is responsible for publishing the SSCP. Unlike in the EU, where the SSCP is published via EUDAMED by the Notified Body, there is currently no central platform for SSCP publication in Switzerland. Manufacturers must ensure they have a mechanism for making the SSCP available to intended users.

Scope of the 2026 Focus Campaign

The 2026 focus campaign has a clearly defined scope, but its breadth means a wide range of manufacturers may be affected.

Which Devices Are Targeted

Swissmedic will randomly select devices from risk classes Class IIa, Class IIb, and Class III. The selection is not limited to specific technologies, clinical specialties, or device categories. All higher-risk medical device categories may be subject to review. This means orthopedic implants, cardiovascular devices, active surgical equipment, in vitro diagnostic devices classified under the higher-risk tiers, diagnostic imaging equipment, and any other Class IIa/IIb/III devices on the Swiss market could be selected.

The random selection methodology means that no manufacturer can assume they will be exempt. Even devices with a clean vigilance history and no prior regulatory actions may be selected.

Which Manufacturers Are Affected

The campaign applies to:

• Swiss-based manufacturers of Class IIa, IIb, or III medical devices placed on the Swiss market
• Foreign manufacturers (including EU and non-EU) who place Class IIa, IIb, or III devices on the Swiss market through a Swiss Authorized Representative (CHREP)

The documentation submission will be handled by the Swiss manufacturer or the Swiss Authorized Representative acting on behalf of the foreign manufacturer. This means CHREPs play a critical role in the campaign and must be prepared to coordinate documentation requests promptly.

What the Selection Process Looks Like

Swissmedic has stated that no proactive response is required from manufacturers at this stage. If a device is selected, the manufacturer (or CHREP) will be notified by a separate letter from Swissmedic. The notification will specify which device has been selected and what documentation must be submitted, along with deadlines.

Manufacturers should not wait for a notification letter to begin preparation. The 2024 campaign demonstrated that assembling PMS documentation under time pressure is a significant challenge, particularly for organizations that have not maintained their PMS systems continuously.

Documentation Swissmedic Will Request

Based on the campaign announcement and the lessons from the 2024 exercise, Swissmedic will request documentation that demonstrates the manufacturer has a functioning PMS system. The documentation falls into several categories:

Documentation Checklist

What Swissmedic Will Specifically Assess

Swissmedic has stated it will assess three core questions:

1. Has the manufacturer established a PMS system under Art. 56 MedDO? This means demonstrating that a systematic process exists for collecting, recording, and analyzing post-market data throughout the device's lifetime.

2. Has the manufacturer outlined activities in PMS plans under Art. 58 MedDO? The plan must be specific, current, and proportional to the device risk. A generic template plan that has not been adapted to the device will not satisfy this requirement.

3. Has the manufacturer documented results in safety reports under Art. 60-61 MedDO? For Class IIa, a safety report must exist and be available. For Class IIb and III, PSURs must be produced at the required frequency and must contain meaningful analysis, not boilerplate text.

What the 2024 Campaign Found

The 2024 Swissmedic PMS focus campaign reviewed PMS documentation for a sample of 30 legacy devices in risk classes IIa and higher. The results, published in Swissmedic's official assessment report (Medical Devices 01/2025), were sobering: non-conformities were raised in 20 out of 30 cases (67%). A total of 85 non-conformities were identified across the 21 clauses in MedDO Articles 56, 58, 60, and 61, in combination with the corresponding EU MDR provisions.

Importantly, 28 out of 30 products were from foreign manufacturers, meaning the documentation was submitted by Swiss Authorized Representatives in the vast majority of cases. In 25 of those 28 cases, CHREPs submitted the requested documents by the due date.

Breakdown by Documentation Pillar

The 85 non-conformities were distributed across the three core documentation pillars:

Specific Safety Report Deficiencies

Swissmedic's 2024 report broke down the safety report non-conformities by individual requirement clause. The most common deficiencies in the safety reports included:

• Missing or incomplete analysis conclusions per the PMS plan
• Benefit-risk determination conclusions not set out
• Total sales volume not documented
• Characteristics of the population using the device not described
• CAPA (corrective and preventive action) documentation missing from the report
• Main PMCF findings not included
• Population size estimates and device usage frequency absent

This granular breakdown is directly relevant to the 2026 campaign. Swissmedic will be looking for the same specific data points in safety reports and PSURs.

Swissmedic's Response

Following the 2024 campaign, Swissmedic triggered corrective actions by the manufacturers with non-conformities and stated it would follow up on the rectification of all NCs, imposing additional measures as needed. Swissmedic urged all manufacturers — not just those selected — to review their PMS processes and documentation. The authority also encouraged Swiss Authorized Representatives to inform the manufacturers with which they have mandates about the 2024 findings.

The 2026 campaign is a direct continuation of this enforcement posture, expanding to a fresh random sample with the same assessment criteria.

Recurring PMS Pitfalls to Watch For

Beyond the specific non-conformity statistics, the 2024 campaign confirmed several patterns that manufacturers should proactively address:

PMS plans that exist on paper but not in practice. Some manufacturers produce PMS plans as technical documentation artifacts for notified body review but do not actively execute the planned data collection and analysis activities. Swissmedic can identify this gap by comparing the plan's described activities against the actual data collected and the conclusions drawn.

PSURs with insufficient analysis. PSURs that merely list complaint counts without meaningful trend analysis, root cause review, or linkage to the clinical evaluation are not compliant. The PSUR must demonstrate that the manufacturer has actively reviewed the data and drawn conclusions about the device's ongoing safety and performance.

Missing or incomplete PMCF data. For devices where clinical data is limited at the time of CE marking, PMCF is essential to confirm device safety and performance in real-world use. Some manufacturers treat PMCF as a formality rather than a genuine clinical data generation activity.

Complaint handling disconnected from PMS. Complaint records that are managed in a quality system but never feed into the PMS analysis represent a broken feedback loop. PMS data must integrate complaint trends, vigilance events, and user feedback into a unified safety assessment.

Trend analysis not performed or not documented. Monitoring trends in non-serious incidents and expected side effects is a specific PMS obligation. Some manufacturers collect the data but do not perform statistical trending or set appropriate reporting thresholds.

Key Guidance Documents for PMS Preparation

Although Swissmedic has not published its own PMS-specific guidance documents, the close alignment between MedDO and EU MDR means that EU guidance is directly applicable. Swissmedic's own 2024 assessment report references MedDO articles in combination with specific MDR provisions, confirming that these documents form the operative legal standard.

MDCG Guidance Documents Applicable to Swiss PMS

Because MedDO cross-references EU MDR Annex III and Article 83, using these MDCG documents to prepare your Swiss PMS documentation is not just helpful — it is effectively required to meet the standard Swissmedic will apply.

Swiss-Specific Forms and Resources

Swissmedic provides Swiss-specific vigilance reporting forms that differ from the EU templates. Manufacturers and CHREPs should ensure they are using the current versions:

• Swiss MIR form (Manufacturer Incident Report) — updated versions published on Swissmedic's website
• Swiss FSCA report form — a Swiss-specific template for Field Safety Corrective Action reports
• Swiss PSR form (Periodic Summary Report) — for reporting similar serious incidents collectively
• Swiss trend report form — for trend reporting to Swissmedic

Always download the current forms from Swissmedic's website before submission, as they are periodically updated.

How to Prepare: Practical Steps for Manufacturers

Whether or not your device is selected in the current campaign, Swissmedic has made clear that PMS compliance will continue to be a focus area. Preparation should be systematic and ongoing, not reactive. Here is a practical roadmap.

Step 1: Audit Your Current PMS Plan

Review your PMS plan for every Class IIa, IIb, and III device on the Swiss market. Ask these questions:

• Is the plan current (reviewed and updated within the last 12 months)?
• Does it describe specific, actionable data collection activities — not vague statements?
• Are the data sources clearly identified (complaints, vigilance, literature, registries, PMCF, user feedback)?
• Is the analysis frequency defined and being followed?
• Does the plan describe how results feed into risk management and clinical evaluation?

If the answer to any of these is no, the plan needs to be updated before you receive a Swissmedic notification letter.

Step 2: Verify PSUR Timeliness and Content

For Class IIb devices, confirm your PSURs are no more than one year old (both Class IIb and Class III require at least annual PSUR updates). For each PSUR, verify that it includes:

• Summary of PMS data collected during the reporting period
• Sales volume and estimated user population
• Analysis of complaints, incidents, and Field Safety Corrective Actions
• Trend analysis results
• PMCF findings (if applicable)
• Benefit-risk conclusions
• Rationale for any corrective actions taken or a statement that no actions were needed

Step 3: Connect Complaints to PMS

Ensure your complaint handling system feeds directly into your PMS process. Every complaint classified as reportable or trend-reportable should appear in the PMS data analysis. The PMS plan should reference the complaint management procedure and define how complaint data is extracted, trended, and incorporated into PSURs and safety reports.

Step 4: Validate PMCF Activities

If your device has PMCF obligations (which most Class IIb and III devices do), confirm that:

• A PMCF plan exists and is being executed
• PMCF data has been collected and evaluated
• PMCF evaluation reports are current and integrated into the clinical evaluation
• Any gaps identified through PMCF have triggered appropriate actions (design changes, labeling updates, additional studies)

Step 5: Document Trend Analysis

Trend analysis should be more than a count of incidents. Document:

• The statistical method used for trending
• The thresholds for trend reporting
• How non-serious incidents and expected side effects are tracked over time
• Whether trends indicate a change in the device's risk profile

Step 6: Ensure Traceability

Every piece of PMS documentation should be traceable. A reviewer should be able to follow the chain from raw data (complaint, vigilance report, literature finding) through analysis to conclusions to corrective actions (if any) and back to the risk management file. Gaps in this chain are red flags for regulators.

Step 7: Rehearse Your Response

Given that Swissmedic will set a deadline for documentation submission, rehearse the process internally. Identify who will coordinate the response, where the documentation is stored, how long it takes to compile, and who reviews it before submission. A well-prepared team can respond within days; an unprepared team may miss the deadline. In the 2024 campaign, 25 out of 28 CHREPs submitted documents by the due date — late submission is a red flag.

Step 8: Harmonize Swiss and EU PMS Documentation

Because MedDO PMS requirements are closely aligned with EU MDR requirements, manufacturers marketing in both markets can synchronize their PMS reporting. However, the data sets must be market-specific:

• Sales figures: Swiss sales data must be separated from EU data
• Field Safety Corrective Actions: Only FSCAs deployed in Switzerland belong in the Swiss PSUR
• Vigilance data: Only incidents occurring in Switzerland (and Liechtenstein under the Customs Treaty) should be included in Swiss submissions
• Literature and registry data: Can be shared across markets, but the analysis conclusions must address the Swiss market context

Use MDCG 2022-21 as the structural template for your PSURs, adapted with Swiss-specific data sections. This approach minimizes duplication while ensuring compliance with both regimes.

Swiss Authorized Representative Obligations

For foreign manufacturers without a registered place of business in Switzerland, the Swiss Authorized Representative (CHREP) serves as the regulatory liaison with Swissmedic. Under MedDO, the CHREP has specific obligations related to PMS documentation.

CHREP Responsibilities in the Campaign

• Receive the notification letter. Swissmedic will send the selection notification to the CHREP on file for the device. The CHREP must promptly inform the manufacturer.
• Coordinate documentation submission. The CHREP is responsible for submitting the requested documentation to Swissmedic within the specified deadline. This requires close coordination with the manufacturer to ensure all documents are current, complete, and properly formatted.
• Maintain records. The CHREP must keep copies of all submitted documentation and correspondence with Swissmedic for the periods required under MedDO.
• Facilitate communication. If Swissmedic requests clarification or additional information, the CHREP acts as the communication channel between Swissmedic and the manufacturer.

What CHREPs Should Do Now

CHREPs should proactively contact their manufacturers to confirm that PMS documentation for all Class IIa, IIb, and III devices on the Swiss market is current and readily available. Waiting for a notification letter to discover that a manufacturer's PMS plan is three years out of date puts both the CHREP and the manufacturer at risk.

Relationship to EUDAMED and swissdamed

The 2026 PMS campaign intersects with two major database systems that manufacturers should be aware of.

EUDAMED

EUDAMED, the European database for medical devices under EU MDR, became mandatory for four modules (Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance) on May 28, 2026. The remaining two modules (Clinical Investigations and Vigilance & Post-Market Surveillance) remain under development. While Switzerland is not an EU member state and does not directly participate in EUDAMED, the regulatory alignment between MedDO and EU MDR means that PMS data generated for EU compliance is directly relevant to Swiss compliance. Manufacturers who maintain robust PMS systems for their EU market obligations will find that much of the same documentation serves the Swiss campaign.

EUDAMED's Market Surveillance module enables EU competent authorities to share vigilance data and coordinate market surveillance actions. Swissmedic, while not directly connected to EUDAMED, monitors EU market surveillance outcomes and may use this information when selecting devices for its own review.

swissdamed

swissdamed is Switzerland's counterpart to EUDAMED, designed to provide a centralized registration and transparency system for medical devices on the Swiss market. As swissdamed becomes operational, it will serve as a key source of device information for Swissmedic's market surveillance activities, including focus campaigns like this one.

Manufacturers should ensure their device registrations in swissdamed are accurate and current. Discrepancies between swissdamed data and the documentation submitted during the PMS campaign could trigger additional scrutiny.

Why Database Accuracy Matters

Both EUDAMED and swissdamed create a digital footprint for every device on the market. If your device registration data is incomplete, outdated, or inconsistent with your technical documentation, regulators will notice. Before the PMS campaign reaches your devices, take the time to verify that your registrations in both databases (as applicable) are aligned with your current device portfolio and documentation.

Consequences of Non-Compliance

Swissmedic has enforcement powers under the Swiss Therapeutic Products Act (HMG, SR 812.21) and MedDO. Non-compliance with PMS obligations can lead to serious consequences:

Regulatory Actions

• Requests for corrective action. Swissmedic may require the manufacturer to address specific PMS deficiencies within a defined timeframe.
• Restrictions on marketing. Swissmedic can restrict or prohibit the further placing on the market of a device found to have inadequate PMS documentation.
• Device withdrawal. In cases where PMS deficiencies indicate an unacceptable risk to patients or users, Swissmedic can order the withdrawal of the device from the Swiss market.
• Field Safety Corrective Actions. If PMS data gaps prevent Swissmedic from assessing device safety, the authority may require the manufacturer to initiate a Field Safety Corrective Action, including device recall.

Reputational and Commercial Impact

Beyond formal regulatory actions, non-compliance has commercial consequences. A finding of inadequate PMS documentation can erode trust with notified bodies, Swiss Authorized Representatives, and distribution partners. For manufacturers seeking to expand their Swiss market presence, a history of PMS non-compliance is a significant liability.

Swissmedic has also indicated that PMS compliance findings from focus campaigns may inform future inspection planning. Manufacturers found non-compliant in the 2026 campaign should expect heightened scrutiny in subsequent years.

Key Takeaways

The Swissmedic 2026 PMS focus campaign is a clear signal that post-market surveillance for higher-risk medical devices is a regulatory priority in Switzerland. Here is what manufacturers should take away:

1. The campaign is real and active. Swissmedic announced it on April 23, 2026, and device selection notifications are being sent. If you have Class IIa, IIb, or III devices on the Swiss market, you may be selected.

2. Random selection means no one is exempt. The selection process does not target specific manufacturers, technologies, or specialties. Any Class IIa, IIb, or III device may be reviewed.

3. The 2024 campaign found widespread gaps. Swissmedic's 2024 assessment found non-conformities in 20 out of 30 cases reviewed (67%), with 85 total non-conformities across PMS systems, PMS plans, and safety reports. The 2026 campaign will apply the same assessment criteria.

4. MedDO references EU MDR directly. Art. 56, 58, and 60-61 MedDO operate in combination with specific MDR provisions (Art. 83, Annex III). Your documentation must address both. Use MDCG guidance documents (especially MDCG 2022-21 for PSURs and MDCG 2019-9 for SSCPs) as the de facto standard.

5. Documentation must be current and complete. A PMS plan from three years ago, a PSUR that only lists complaint counts, or a complaint management process disconnected from PMS analysis will not satisfy Swissmedic.

6. CHREPs are in the front line. For foreign manufacturers, the CHREP receives the notification and coordinates the response. Ensure your CHREP is informed and prepared.

7. PMS obligations are non-negotiable. Swissmedic has stated this plainly. Further inspections may occur at any time, not just during announced focus campaigns.

8. Do not wait for the letter. The best time to prepare was before the campaign was announced. The second best time is now. Audit your PMS documentation, close the gaps, and be ready to respond promptly if selected.

Post-market surveillance is not a regulatory afterthought. It is the mechanism by which manufacturers confirm that their devices remain safe and effective throughout their market lifetime. Swissmedic's focus campaigns exist to ensure that this mechanism works — not on paper, but in practice. Manufacturers who invest in genuine, data-driven PMS systems will not only survive regulatory scrutiny but will also improve their products and protect their patients.