Medical Device Log and Inventory Register: Mandatory for Every Practice

What is a medical device log?

The medical device log (Medizinproduktebuch) is a legally required document under Section 12 MPBetreibV. It must be maintained for every active medical device listed in Annex 1 of the MPBetreibV or subject to a safety technical inspection (STK).

The medical device log is the central document in which the entire lifecycle of a medical device is recorded — from initial commissioning to decommissioning. It serves as proof for authorities, social accident insurers and in liability cases.

For which devices is a medical device log mandatory?

A medical device log must be maintained for:

• All medical devices listed in Annex 1 MPBetreibV (e.g. defibrillators, infusion pumps, ventilators)
• All medical devices for which the manufacturer prescribes an STK
• Devices with a measuring function under Annex 2 (additional MTK documentation required)

Important: Cosmetic devices falling under MDR Annex XVI may also be subject to documentation obligations analogous to the medical device log in the future.

Contents of the medical device log per Section 12 MPBetreibV

The medical device log must contain the following information:

• ✓ Device master data: Designation, manufacturer, model, serial number, year of manufacture, protection class
• ✓ Training records: Date, name of the person trained, name of the trainer, scope of the training
• ✓ Maintenance activities: Servicing, inspections, repairs with date and result
• ✓ Test reports: STK results, DGUV V3 tests, DIN EN 62353 measurements
• ✓ Malfunctions and reports: Incident reports per Section 3 MPSV
• ✓ Safety corrective actions: Recalls and safety information from the manufacturer

The inventory register per Section 13 MPBetreibV

In addition to the medical device log, Section 13 MPBetreibV requires an inventory register. The key difference: the inventory register must be maintained for all medical devices — not just Annex 1 devices.

Contents of the inventory register

Format: The MPBetreibV does not prescribe a specific format. The inventory register may be kept as an Excel spreadsheet, in a database or on paper.

Common documentation mistakes

During inspections by authorities or social accident insurers, the same shortcomings are found time and again:

• ✓ Missing training records: Every person who operates a medical device must have documented training — including temporary staff and new employees
• ✓ No maintenance records: Servicing and repairs were carried out but not documented
• ✓ Outdated device master data: Devices were replaced but the inventory register was not updated
• ✓ Missing test reports: STK or DGUV V3 tests were performed but the reports are not filed in the medical device log
• ✓ No inventory register: Many practices and studios are unaware that an inventory register is mandatory

Retention period

The medical device log and inventory register must be retained for at least 5 years after decommissioning of the respective device. This period also applies to all associated test reports and training records.

Our recommendation: keep the records longer than required. In liability cases, documentation may still be requested after 5 years if the damage occurred during the operating period.

Sanctions during inspections

The supervisory authorities (in Baden-Wuerttemberg the Regional Council) can impose severe measures for violations of documentation obligations:

• Fines under Section 40 MPG or the corresponding state regulations
• Prohibition of use for individual devices or the entire operation
• Conditions: Deadlines set for rectifying the documentation
• Follow-up inspection with additional fees

Particularly critical: in the event of damage (e.g. patient injury from a defective device), complete documentation becomes the decisive piece of evidence. If records are missing, contributory negligence on the part of the operator is presumed.

Digital vs. analogue record-keeping

The MPBetreibV permits both methods:

Our recommendation: maintain the medical device log and inventory register digitally. With more than 10 devices, analogue management quickly becomes confusing and error-prone.

How a professional testing service supports your documentation

As an external testing service provider, we deliver not only the testing itself but also complete documentation that can be directly incorporated into your medical device log:

• ✓ Individual test reports for each device with all measured values
• ✓ Complete overview of all tested devices with assessment
• ✓ Next testing date noted on every report
• ✓ Support in setting up the inventory register (initial recording)
• ✓ Digital device management with automatic deadline tracking