Introduction: Notified Body Decisions Now Affect Device Security Worldwide

CE conformity assessment is mandatory for medical devices to be placed on the European Union market. The CE process is carried out by independent inspection and certification bodies called Notified Bodies

However, in recent years:

• manufacturing defects

• missing technical file,

• design flaw,

• Lack of clinical data

• quality management system problems

As a result , Notified Body has issued suspension or withdrawal decisions against many manufacturers .

So what is the legal effect of these decisions in Türkiye?

➡️ Does the suspension of a CE certificate by an approved body automatically become valid in Turkey?
➡️ Will the product be immediately withdrawn from the market in Turkey?
➡️ Is the Turkish Medicines and Medical Devices Agency (TİTCK) obliged to take action in accordance with this decision?

This article answers these critical questions according to Turkish law.

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1. What is a Notified Body and what is its legal status in Türkiye?

Notified Body:

✔ It is an organization that performs product conformity assessments under EU regulations

✔ Issues CE certificate

✔ Performs inspections according to product category

However, in terms of Türkiye, Notified Body:

❗ This is an international private auditing firm, not a public authority.

Therefore, their decisions:

➡️ directly binding .

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2. Does a Notified Body Suspension Decision Automatically Take Effect in Türkiye?

❗ No.

This decision occurs when a Notified Body suspends a CE certificate

• It does not automatically apply in Türkiye

• This does not require the product to be immediately withdrawn from the market

• This does not eliminate the approval and inspection authority of the Turkish Medicines and Medical Devices Agency (TİTCK).

Reason:

✔ Principle of territoriality

✔ The fact that TİTCK is an independent regulatory authority

✔ Article 5 of the Private International Law Act (supremacy of mandatory provisions)

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3. However, the decision to suspend [the program] is a very strong risk signal in Türkiye

When TİTCK saw the suspension decision:

✔ We review the UDS records

✔ It can stop the circulation of products

✔ You can request sample tests in the warehouses

✔ Requires technical file verification

✔ Examines AE/SAE history

✔ They can open an investigation

Therefore, the Notified Body decision is one of the strongest indicators triggering independent administrative review in Turkey

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4. Why is the binding force of suspension decisions limited under Turkish law?

In the Turkish legal system, product safety decisions can only be made by:

➡️ Turkish Medicines and Medical Devices Agency (TİTCK
) ➡️ Ministry of Industry and Technology
➡️ Market Surveillance and Inspection (PGD) mechanisms

can get it.

A Notified Body:

• Subject to EU private law,

• It is a commercial auditing firm

• It does not possess territorial sovereign authority.

Because:

➡️ Administrative sanctions cannot be imposed,
➡️ The CE suspension decision cannot be made mandatory in Turkey.

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5. The Most Important Consequence of the Suspension Decision in Türkiye: Product Safety Investigation

The process initiated by TİTCK (Turkish Medicines and Medical Devices Agency) is generally as follows:

Stage 1 – Preliminary Assessment

The documents are requested from the manufacturer.

Phase 2 – Market Surveillance

Hospitals, warehouses, and distributors are inspected.

Stage 3 – Technical Analysis

Sample tests are performed.

Stage 4 – Risk Assessment

If the product is found to be harmful:

• Suspension

• Collection

• Import halt

Decisions can be made.

This is entirely Turkey's own assessment.

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6. Responsibility of the Foreign Producer in the Suspension Decision

Suspension decisions are usually made for the following reasons:

✔ Quality management system (QMS) non-conformity

✔ Missing technical file

✔ Place of manufacture non-compliance

✔ Lack of a risk management plan

✔ Design flaws

✔ Lack of clinical data

These errors occur in Türkiye:

• compensation,

• collection,

• stop imports,

• AE reviews

She gives birth.

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7. The domestic distributor is fully responsible for the suspension decision

Local distributor and importer:

✔ The decision to suspend the product must be reported to TİTCK within 24–72 hours

✔ They must isolate the product from the market

✔ They are obliged to inform customers/hospitals

If he/she does not report it:

❗ Administrative fine

❗ Suspension of distribution permits

❗ Liability for damages

is born.

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8. The Evidential Value of Notified Body Decisions in Courts

Turkish courts have issued suspension orders:

✔ Indicator of manufacturing defects

✔ Technical safety signal

✔ Proof of product-related risk

✔ Supporting evidence indicating the existence of a defect

He accepts it as such.

However:

➡️ This is not binding; expert review is required.

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9. The Impact of the Suspension Decision on Clinical Trials

If the CE certification for a device used in clinical trials is suspended:

✔ TİTCK can halt the investigation

✔ An alternative device can be requested

✔ AE/SAE review is expanded

✔ Sponsor responsibility is increased

Because device safety is a critical threshold.

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10. Conclusion: Notified Body Suspension Decisions are Not Binding in Türkiye, but They are the Strongest Security Alarm

According to the 2025 plan:

• Suspension decisions are not automatically implemented in Turkey

• TİTCK initiates independent investigations as a risk signal

• The local distributor is obligated to notify of this decision within 24–72 hours

• Foreign producers and domestic importers share joint responsibility.

• This can result in consequences such as recalls, import stoppages, and compensation payments

• In courts, a suspension order constitutes strong evidence.

• Suspending CE certification in clinical trials has very serious consequences

In short: A Notified Body decision is not legally binding, but it is effectively the most important security alert.