Testing Intervals for Medical and Cosmetic Devices: The Complete Overview

Why a testing intervals overview?

Operators of cosmetic studios, medical practices, care facilities, and clinics face the challenge of complying with various testing obligations from different legal bases. Depending on the device type, the MPBetreibV, DGUV Vorschrift 3, the NiSV, and the Occupational Health and Safety Act may apply simultaneously — with different intervals, testing types, and tester qualifications.

This overview brings order to the topic and shows for each device type which tests are due and when.

The comprehensive testing intervals table

Medical devices — Annex 1 MPBetreibV (STK-mandatory)

Medical devices — other (not Annex 1)

Annex XVI products (MDR) — Cosmetic devices with medical device status

Note: The exact testing requirements under MDR Annex XVI are still partially being implemented. More on this in our article MDR Annex XVI explained.

Pure cosmetic devices (not a medical device)

General electrical devices

What happens when testing intervals are exceeded?

The consequences of exceeding an interval vary in severity depending on the device type and legal basis:

Liability

In the event of damage caused by a device that was not tested on time, the operator is personally liable. The burden of proof is reversed: the operator must demonstrate that the damage would have occurred even with proper testing. In practice, this is virtually impossible to prove.

Insurance coverage

Business liability and professional liability insurance may reduce or deny benefits if the damage was caused by an untested device. The statutory accident insurance (Berufsgenossenschaft) can also seek recourse against the operator.

Fines

• ✓ DGUV V3: Fines up to 10,000 EUR from the professional association
• ✓ MPBetreibV: Fines for violations of §12 (STK) or §15 (MTK)
• ✓ NiSV: Fines up to 50,000 EUR per violation
• ✓ BetrSichV: Fines up to 25,000 EUR for violations of testing obligations

Prohibition of operation

For STK-mandatory medical devices (Annex 1), the device may no longer be used after the deadline expires until the STK has been completed. Under DGUV V3, the professional association or trade supervisory authority can prohibit use.

Tip: The risk assessment determines the intervals

The intervals listed in the tables are guideline values and maximum intervals. The specific testing intervals for your operation result from the risk assessment per §3 BetrSichV. The following factors play a role:

• ✓ Frequency of use: Devices used daily are subject to greater stress
• ✓ Environmental conditions: Humidity, dust, temperature
• ✓ Type of use: Devices with skin contact carry a higher risk
• ✓ Manufacturer specifications: Always take precedence over general guideline values
• ✓ Previous test results: Frequent defects may justify shorter intervals
• ✓ Age of the device: Older devices may require shorter intervals

Special case: Testing after repair or maintenance

Regardless of regular testing intervals: After every repair, maintenance, or modification of a device, a new test must be performed before recommissioning. This applies to:

• ✓ Medical devices: §7 MPBetreibV — testing after maintenance
• ✓ General devices: DIN EN 50678 (formerly DIN VDE 0701) — testing after repair
• ✓ Replacement of wear parts (e.g. IPL lamp) also counts as maintenance

Have your testing intervals checked now

Unsure which intervals apply to your devices? We are happy to advise you and take over interval management:

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