Medical device safety plan regulation
| Basic data | |
|---|---|
| Title: | Ordinance on the recording, evaluation and defense of risks in medical devices |
| Short title: | Medical device safety plan regulation |
| Abbreviation: | MPSV |
| Type: | Federal Ordinance |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | Section 37 Paragraphs 2, 5, 7, 11 MPG |
| Legal matter: | Administrative law , trade law |
| References : | 7102-47-8 |
| Issued on: | June 24, 2002 ( Federal Law Gazette I p. 2131 ) |
| Entry into force on: | June 28, 2002 |
| Last change by: |
Art. 7 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 Medical Device Safety Plan Ordinance is used to record, evaluate and defend against risks in traffic or in use medical devices in accordance with Section 3 of the Medical Devices Act (MPG). It was issued on the basis of § 37 MPG and at the same time the set of rules for all users and operators of medical devices. The MPSV does not apply to medical devices for clinical testing and in vitro diagnostics for performance evaluation purposes.
Content of the regulation
- Section 1 Scope, Definitions
- § 1 Scope
- § 2 Definitions
- Section 2 Incident Reporting and Recalls
- § 3 reporting obligations
- § 4 Exceptions to the reporting requirement and special procedures
- § 5 Deadlines
- § 6 Notification by Distributor
- § 7 Modalities of the notification
- Section 3 Risk assessment by the competent higher federal authority
- § 8 Duties of the Authority
- § 9 Aim and content of the risk assessment
- Section 10 Risk Assessment Procedure
- § 11 Powers of the Authority
- § 12 Obligations to Cooperate
- § 13 Completion of the risk assessment
- Section 4 Corrective Actions
- § 14 Responsible corrective measures of the person responsible according to § 5 of the Medical Devices Act
- Section 15 Measures by the competent authorities against manufacturers, authorized agents, importers or distributors
- § 16 Obligation to participate in corrective measures
- § 17 Measures by the competent authorities against operators and users
- § 18 Emergency planning by the competent authorities
- Section 5 Notification Duties and Exchange of Information
- Section 19 Notification of the Federal Ministry of Health by the competent federal authority
- Section 20 Exchange of information between the competent higher federal authority and the competent state authorities
- § 21 European and international exchange of information
- § 22 Informing other authorities, organizations and bodies
- § 23 Scientific processing of the risk assessments carried out
- § 24 Publication of information on the Internet
