Medical device operator regulation

Basic data
Title:	Ordinance on the installation, operation and use of medical devices
Short title:	Medical device operator regulation
Abbreviation:	MPBetreibV
Type:	Federal Ordinance
Scope:	Federal Republic of Germany
Issued on the basis of:	§§ 2, 3 EichG , ; §§ 22, 23, 24, 36 MPG
Legal matter:	Administrative law , trade law
References :	7102-47-11
Original version from:	June 29, 1998 ( BGBl. I p. 1762 )
Entry into force on:	July 7, 1998
New announcement from:	August 21, 2002 ( BGBl. I p. 3396 )
Last change by:	Art. 9 VO of November 29, 2018 ; ( Federal Law Gazette I p. 2034, 2197 )
Effective date of the ; last change:	December 31, 2018 ; (Art. 20 of November 29, 2018)
	Please note the note on the applicable legal version.

The ordinance on the installation, operation and use of medical devices (Medical Devices Operator Ordinance - MPBetreibV) is based on the authorization of Section 37 (5) of the Medical Devices Act (MPG). It regulates the installation, operation, use and maintenance of medical devices according to § 3 MPG and is the national set of rules for all professional installers, users and operators of medical devices. Proven regulations of the (former) Medical Devices Ordinance (MedGV, expired on January 1, 2002) and regulations of the calibration law were adopted in the MPBetreibV. In addition, requirements for hygiene in the reprocessing of medical products and for quality assurance of medical laboratory tests have been incorporated into the regulation.

The MPBetreibV excludes medical devices that are intended for clinical testing .

Content of the regulation i. d. F. since January 1, 2017

- § 1 Scope
- § 2 Definitions
- § 3 Obligations of an operator
- § 4 General Requirements
- § 5 Special requirements
- § 6 Medical Device Safety Officer
- § 7 Maintenance of Medical Devices
- § 8 reprocessing of medical devices
- § 9 Quality assurance system for medical laboratories
- § 10 Operation and use of selected active medical devices
- § 11 Safety checks
- § 12 Medical Device Book
- § 13 Inventory
- § 14 Metrological controls
- § 15 Special obligations for implantable medical devices
- Section 16 Medical Devices of the Bundeswehr
- Section 17 Administrative offenses
- § 18 Transitional Provision
- § 19 Special Provisions

such as

Appendix 1 (to Section 10 Paragraphs 1 and 2, Section 11 Paragraph 1 and Section 12 Paragraph 1)

Appendix 2 (to Section 12 Paragraph 1 and Section 14 Paragraph 1)

Appendix 3 (to Section 15 Paragraphs 1 and 2).

Duties and duties

According to the ordinance , medical devices may only be installed, operated, used and maintained in accordance with the provisions of the ordinance, the generally recognized rules of technology and the industrial safety and accident prevention regulations.

Operator obligations

The so-called operator is responsible for the commissioning and operation of the medical device, which means that the legal provisions on the medical device are observed and implemented. He is the owner of the medical device and exercises daily business about the physical control of. This can be a natural person (owner of a doctor's practice), but also a legal person who is responsible for the operation of the health facility, for example the operator of a hospital or nursing home.

The operator must create the organizational prerequisites for the intended use of the product and ensure that the operating personnel have the necessary expertise and reliability. The operator's duties also include ensuring the functionality and proper condition of the product. Only people who have the necessary expertise may be entrusted with maintenance. Recommendations for the qualification for the reprocessing of medical devices were drawn up by the KRINKO, the RKI and the BfArM.

Anyone who supplies patients with medical products for use by themselves or by third parties in a private environment based on a legal or contractual obligation is also an operator with the resulting obligations. These are so-called service providers such as health and long-term care insurances or private health insurance companies and other providers who are obliged to supply medical products due to legal regulations. Service providers can contractually transfer their operating obligations to the service providers (e.g. homecare companies or medical supply stores). The respective service provider must ensure that the requirements are met according to the ordinance.

If a patient takes the medical device provided by a service provider with him to a health facility (e.g. doctor's practice, hospice, hospital, nursing home, practices of psychological psychotherapists, physiotherapists, day care and workshops for disabled people), the operator's obligations remain with the service provider as long as the service provider alone Patient operates the medical device. But if the staff takes over the operation for therapeutic purposes on the patient, the health facility becomes the operator and is responsible for the instruction, maintenance and other controls. The situation is different if the patient brings a medical product that he has bought on his own responsibility. The condition of the product must be checked when it is picked up - especially with regard to function, hygiene and safety. The facility should not assume the operator's obligations if no evidence (instructions for use, invoice, maintenance log) was carried. In this case, a corresponding internal medical product is made available or a supply is organized by an external provider.

Almost all operator obligations end when the medical device has been demonstrably sold, replaced or disposed of by the service provider. However, the corresponding medical device book must be kept for five years after the medical device has been taken out of service.

User obligations

A person who only operates the medical device in the context of their professional practice is not an operator in the sense of the regulation, but a user. Medical devices may only be used for their intended purpose and in accordance with the generally recognized rules of technology. They may only be operated and used by persons who have the appropriate training or knowledge and experience. A briefing is required for the proper handling of the medical device ; unless the medical device is self-explanatory or a briefing on an identical model has already taken place. A medical product advisor according to MPG § 31 is usually responsible for technical information and instruction

The instruction for active non-implantable medical devices must be documented.

Before use, the medical device must be subjected to a visual and functional test. If the expiry date has passed or an error is found, it must not be used. Incidents such as errors in the device or in the instructions for use must be reported to the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute and the manufacturer. Medical devices with an expired use-by date must not be used ( Section 4 (1) No. 2 of the Medical Devices Act).

Medical Device Safety Officer

A medical device safety officer is the contact person for authorities, manufacturers and sales companies in health facilities with more than 20 permanent employees. He must have a medical, scientific, nursing, pharmaceutical or technical training and be reachable via a functional e-mail address on the institution's website. His tasks include, among other things

initiate or support the necessary corrective measures in the event of reports about risks of medical devices or recall measures
Coordinate internal processes of the health care facility in order to meet the reporting and cooperation obligations of users and operators.

Inventory

All active, non-implantable medical devices in a permanent establishment must be listed in the inventory with type and type, lot code or the serial number and year of purchase. In addition, the name and address of the person responsible for the respective medical device according to § 5 of the Medical Devices Act (usually the manufacturer) and - if available - the identification number of the notified body are noted ( § 13 Paragraph 2 No. 3 of the Medical Devices Operator Ordinance) .

Medical device book

For the medical devices listed in Appendices 1 and 2 , the medical device log documents, among other things, evidence of functional testing, instruction, safety and metrological controls.

Web links

Individual evidence

↑ KRINKO, RKI and BfArM: Hygiene requirements for the reprocessing of medical products (Annex 6). Retrieved January 9, 2019 .

[1] KRINKO, RKI and BfArM: Hygiene requirements for the reprocessing of medical products (Annex 6). Retrieved January 9, 2019 .