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Competent authority-initiated actions

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Regulatory basis - MDR Art. 93–97 / IVDR Art. 88–92. National competent authorities have broad powers to investigate, restrict, and remove medical devices from the EU market. The European Commission can intervene at EU level where national actions are insufficient.

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Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

NCA market surveillance powers​

National Competent Authorities are not passive recipients of manufacturer vigilance reports. Under MDR Art. 93, NCAs have the power and obligation to conduct active market surveillance — proactively investigating devices on the market without waiting for reports.

Market surveillance activities include:

  • Documentary checks: reviewing technical documentation, Declaration of Conformity, and labelling
  • Physical inspections: examining devices on the market against their technical specifications
  • Testing: arranging laboratory tests of devices
  • Inspections of manufacturers: including unannounced inspections of manufacturing sites
  • Investigation of complaints and vigilance reports: following up on reported incidents

When NCAs can act — the risk threshold​

An NCA may take action against a device when it has established that the device:

ConditionNCA power
Presents an unacceptable risk to health or safetyOrder the manufacturer to take corrective action, restrict or prohibit placing on market, require withdrawal
Does not comply with MDR/IVDR requirementsRequire the manufacturer to bring the device into compliance; restrict market access if not remedied
Is the subject of a serious incident requiring immediate actionOrder immediate restriction or withdrawal pending investigation

NCA corrective action orders — MDR Art. 95​

Where an NCA determines that a device presents an unacceptable risk and the manufacturer has not taken adequate voluntary action, it may require:

  1. Corrective action: modification of the device, labelling update, user advisory
  2. Restriction of placing on the market: limiting sale to specific settings or users
  3. Prohibition of placing on the market: stopping all new sales
  4. Withdrawal from the market: requiring recall from distributors and customers
  5. Suspension of clinical investigations: where an investigation poses unacceptable risk
  6. Destruction of the device: in extreme cases

The manufacturer has the right to submit observations before the NCA takes action — except in cases requiring urgent action.

Safeguard procedure — Art. 95 and Art. 97​

Where an NCA takes a restrictive measure against a device, it must:

  1. Immediately inform the European Commission, other NCAs, and the notified body via EUDAMED (the SCENIHR/safeguard notification system)
  2. Explain the reasons for the measure

Other NCAs must then investigate whether the same concern applies to the device in their own territory and take proportionate action.

The European Commission reviews the NCA measure and either:

  • Confirms it (where justified)
  • Requires the NCA to withdraw or modify it (where unjustified)
  • Takes an EU-wide measure (Art. 97) where the issue is systemic and national measures are inconsistent

Unannounced NCA inspections​

NCAs may conduct unannounced inspections of manufacturer premises, including:

  • Manufacturing sites
  • Storage and distribution facilities
  • Quality management system records

For Class III and implantable Class IIb devices, MDR Art. 93(3) explicitly requires NCAs to conduct at least some unannounced inspections, in addition to those conducted by notified bodies under Art. 93.

Manufacturer obligations when contacted by an NCA​

When an NCA contacts a manufacturer regarding a market surveillance investigation, the manufacturer must:

  1. Cooperate fully — MDR Art. 10(12) requires manufacturers to cooperate with competent authorities on any action taken to eliminate or mitigate risks
  2. Provide documentation promptly — technical documentation, quality management records, complaint files, and vigilance reports must be made available on request
  3. Implement required actions — where the NCA requests corrective action, the manufacturer must implement it within the specified timeframe
  4. Report to the NCA on the status of any corrective actions taken

Failure to cooperate with NCA market surveillance investigations is a serious regulatory non-compliance and may result in escalated enforcement action.

The MDCG's role in coordinating NCA actions​

Where a safety issue has EU-wide implications, the MDCG coordinates NCA responses through its working groups. The MDCG may:

  • Issue guidance clarifying regulatory obligations
  • Coordinate simultaneous market surveillance actions across multiple member states
  • Advise the Commission on appropriate EU-level measures

Official references​

ReferenceDescription
MDR Art. 93Market surveillance by NCAs
MDR Art. 95NCA corrective action and withdrawal powers
MDR Art. 96Procedure for devices presenting unacceptable risk
MDR Art. 97Commission safeguard procedure
IVDR Art. 88–92IVDR equivalent provisions
MDR Art. 10(12)Manufacturer duty to cooperate with NCAs