EU MDR Market Surveillance under Articles 93 to 100

1. Key takeaways

Articles 93 to 100 of the MDR form the market surveillance chapter: the competent authorities of the Member States must organise and perform market surveillance activities (Article 93), be equipped with the corresponding powers and resources, and act against non-compliant devices. Article 95 sets out the procedure to be followed for devices presenting an unacceptable risk; Article 100 governs the exchange of market surveillance information between Member States and the Commission, and its electronic system (the market surveillance module) has been declared functional by Commission Decision (EU) 2025/2371 and is mandatory from 2026-05-28.

For manufacturers, importers and distributors, this chapter defines the enforcement environment in which every post-market obligation is ultimately tested: authority inspections, requests for information, and measures against devices found non-compliant. A device that carries a CE certificate is not thereby immune from these activities.

The practical starting point for manufacturers is to understand what the authorities actually do: they select devices for inspection, request technical documentation, examine the PMS and vigilance records described elsewhere on this site, and take measures when conformity is in doubt. Because the market surveillance module makes findings visible across Member States from 2026-05-28, an inspection result in one country now has a wider audience than before. Preparation therefore pays twice: it reduces the risk of findings, and it reduces the propagation of any finding that does occur.

2. Legal basis

The obligations and milestones below come from Regulation (EU) 2017/745, the Commission decision on the electronic system, and the transitional regulation cited here.

3. Expert insights

Insight 1: Market surveillance is Member State enforcement activity, a separate line from notified body assessment.

Notified body assessment resolves the question of conformity evidence before the market; market surveillance addresses the actual conformity status after the market. A device that holds a CE certificate and carries the CE marking may still be found non-compliant as a result of a market surveillance inspection. When the conclusions of the two lines diverge, the company has to respond to each on its own terms: correcting the notified body findings does not close an authority finding, and vice versa. Treating the two as one merged compliance workload is a structural mistake. A practical way to keep the lines apart is to route authority correspondence through one owner and notified body correspondence through another, with both owners reading the same status log so that parallel proceedings never contradict each other.

Insight 2: The Article 95 procedure targets unacceptable risk, and its consequences are serious.

Where a competent authority finds that a device presents an unacceptable risk, the procedure of Article 95 applies and may include requiring the economic operators concerned to take measures, restricting supply, withdrawing the device from the market or recalling it. Companies receiving such a notice must respond within the procedure, provide the requested information and cooperate with the authority. A prepared response process, with a lead person, defined document retrieval paths and agreed external communication lines, determines how much control the company retains during the procedure. The phrase unacceptable risk should not be read as a formality: it triggers a defined procedural path with deadlines for the economic operator, and treating the first notice as routine correspondence is a costly misjudgement.

Insight 3: Once the market surveillance module is mandatory, cross-Member-State visibility rises.

The electronic information exchange system under Article 100 (the market surveillance module) has been declared functional by Commission Decision (EU) 2025/2371 and is mandatory from 2026-05-28. The practical consequence is that non-compliance measures taken in one Member State become more easily visible to the others, and cross-market compliance consistency moves from best practice to operational requirement (a practical estimate). Companies selling across several Member States should audit their own consistency before the authorities do it for them.

Insight 4: Economic operators must cooperate and provide information.

Importers and distributors carry verification and notification duties under Articles 13 and 14 and, within market surveillance, must also cooperate with the competent authorities and provide traceability information. Traceability rests on UDI data and distribution records; gaps in either leave the company in a passive position during inspections, because batch flows and supply paths cannot be reconstructed on demand. Distributors and importers are part of the inspection surface: authorities can audit their premises and their records, and a manufacturer whose partners cannot produce distribution records shares the consequences. Contract clauses on record keeping, plus periodic checks of partner records, close the most common gap.

4. Practical recommendations

The measures below prepare the company for the inspection itself and for the measures that may follow it.

1. Establish a response process for competent authority inspections: lead person, document retrieval path, response time limits and external communication lines.
2. Keep distribution records and UDI data traceable so that batch flows can be located quickly during an inspection.
3. Establish dual channels for appeal and remediation of non-compliance findings, and retain the full correspondence.
4. For products sold across markets, align labelling, instructions for use and registration information across Member States to reduce inconsistency risk.
5. Monitor information visibility after the market surveillance module goes live and include compliance consistency in routine internal audits.

5. Verification checklist

Use the checklist below before a planned inspection and after any authority contact.

• □ A response process for competent authority inspections is in place
• □ Distribution records and UDI data support batch traceability
• □ Appeal and remediation channels for non-compliance findings are established
• □ Consistency of labelling, instructions for use and registration information across Member States has been checked
• □ Mandatory use date of the market surveillance module (2026-05-28) has been confirmed
• □ Compliance consistency is covered in routine internal audits

Regulatory information verified as of 29 October 2026.

GRZAN regulatory support. GRZAN assists medical device manufacturers with post-market compliance in the European Union market under Regulation (EU) 2017/745, covering vigilance reporting, field safety corrective action (FSCA) recalls, and responses to competent authority inspections and market surveillance procedures. If you need support with your EU MDR post-market obligations, contact info@grzanglobal.com.