An MDR concern does not automatically lead to a recall, fine, or criminal case. The authority first evaluates the facts, the applicable requirement, the risk, and the response of the economic operators.
Regulation (EU) 2017/745 sets out the market-surveillance sequence in Articles 93 to 100. Penalties are addressed separately in Article 113 and are created by Member State law.
The correct article map
| MDR provision | Function |
|---|---|
| Article 93 | Market-surveillance activities and checks |
| Article 94 | Evaluation of devices suspected of presenting unacceptable risk or other non-compliance |
| Article 95 | Procedure for devices that present an unacceptable risk |
| Article 96 | Evaluation of national measures at Union level |
| Article 97 | Other non-compliance that does not amount to an unacceptable risk under Article 95 |
| Article 98 | Preventive health-protection measures in exceptional circumstances |
| Article 99 | Good administrative practice |
| Article 100 | Electronic system for market-surveillance information |
| Article 113 | National rules on penalties |
Older versions of this guide incorrectly described Article 92 as corrective action and Article 95 as the penalties provision. Article 92 concerns analysis of vigilance data. The table above follows the official MDR text.
Stage 1: checks under Article 93
Competent authorities perform checks on device characteristics and performance. Depending on the case, they may review documents, inspect premises, and request or test samples.
The HPRA’s market-surveillance explanation gives a practical public example. It says the authority evaluates information from manufacturers, users, and other regulators, prioritises according to factors such as public-health risk and use in Ireland, reviews documentation, conducts inspections, and can request samples.
An inspection or information request does not itself prove a breach. Authorities use these tools to establish the facts.
Stage 2: evaluation under Article 94
If an authority has reason to believe a device may present an unacceptable risk or otherwise fails to comply with the MDR, Article 94 requires an evaluation covering the relevant requirements.
The evaluation may consider:
- the device’s intended purpose and classification;
- technical documentation and conformity-assessment records;
- clinical and performance evidence;
- risk-management and post-market-surveillance records;
- labelling and Instructions for Use;
- UDI and registration duties;
- vigilance reports and field actions; and
- whether an economic operator has already corrected the issue.
The outcome may be no finding, a request for more information, a non-compliance finding, or a risk finding. The public reporter normally does not possess all the evidence available to the authority.
Stage 3A: unacceptable risk under Article 95
When the evaluation establishes an unacceptable risk to health or safety, the competent authority requires appropriate corrective action. Measures must be proportionate and can include:
- bringing the device into compliance;
- restricting or prohibiting availability;
- withdrawing the device from the market; or
- recalling devices already supplied.
The authority can also take measures itself when the economic operator does not act adequately within the required period. Cross-border cases can trigger Union-level notification and evaluation under Article 96.
The precise action depends on the risk and facts. Article 95 is not an automatic recall rule for every documentation defect.
Stage 3B: other non-compliance under Article 97
Article 97 covers a device that does not comply but does not present the unacceptable risk addressed by Article 95. Examples listed in the Regulation include:
- incorrect or absent CE marking;
- missing information required under Article 10;
- unfulfilled registration requirements;
- no authorised representative where one is required;
- missing or incomplete technical documentation;
- failure to meet economic-operator duties; and
- failure to conduct required post-market surveillance.
The authority requires the relevant economic operator to end the non-compliance within a reasonable, clearly defined period proportionate to the issue. If the problem continues, the Member State takes appropriate measures to restrict, prohibit, withdraw, or recall the device.
This sequence is why a careful report should distinguish a possible documentation defect from an immediate serious safety risk.
Manufacturer action and authority action are different
A manufacturer may undertake a field safety corrective action, such as a software update, revised instructions, device correction, withdrawal, or recall. The authority evaluates whether the action is adequate and may require more.
An authority may also impose its own restriction or enforcement measure. A public notice does not always reveal every underlying exchange, and the absence of a notice does not prove that no assessment occurred.
Penalties under Article 113
Article 113 requires Member States to set penalties for infringements and to take measures necessary to implement them. The penalties must be effective, proportionate, and dissuasive.
The MDR does not supply one EU-wide fine table. Administrative fines, criminal offences, responsible persons, limitation periods, and procedure depend on national law and the facts. A figure from one country cannot be presented as the standard consequence across the European Union.
Do not estimate fines or criminal exposure from a generic article. Obtain advice in the relevant Member State.
What determines the outcome
Authorities can consider:
- seriousness and likelihood of harm;
- scale and duration;
- number of affected devices and countries;
- intent, negligence, and cooperation;
- whether the issue is isolated or systemic;
- speed and adequacy of corrective action;
- previous history; and
- the legal powers and penalty rules in the relevant Member State.
Published action may include a safety notice, restriction, recall, inspection result, national penalty, or other measure. It may also involve confidential steps that are not visible to the public.
How to write about consequences responsibly
Use conditional language until an authority or court has made a finding. Link to the authority decision, warning, safety notice, or judgment when describing a real case. State the jurisdiction and date.
Avoid:
- invented case studies;
- unsupported fine ranges;
- guaranteed response times;
- calling a suspected defect criminal;
- treating a database search as a final legal conclusion; and
- claiming that a complaint caused an outcome without evidence connecting the two.
A well-sourced evidence packet can help an authority assess a concern. It cannot determine the authority’s decision in advance.
Last checked against EUR-Lex, European Commission, and HPRA public sources on 29 July 2026. This guide is general information and has not been approved by a lawyer or regulatory professional.