Regulation on the collection, evaluation and defence of risks in the case of medical devices (Medical Devices Safety Planning Regulation-MPSV)

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MPSV

Date of completion: 24.06.2002

Full quote:

" Medical Devices Security Planning Ordinance of 24 June 2002 (BGBl. 2131), as last amended by Article 279 of the Regulation of 31 August 2015 (BGBl I). I p. 1474).

Status:

Last amended by Art. 279 V v. 31.8.2015 I 1474

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 28.6.2002 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 ERL 47/2007 (CELEX Nr: 32007L0047)  G v. 29.7.2009 I 2326 
 Implementation of the 
 EGV 765/2008 (CELEX Nr: 32008R0765)  G v. 29.7.2009 I 2326 + + +) 

  

The V was referred to as Article 1 (d). V v. 24.6.2002 I 2131 of the Federal Ministry of Health in agreement with the Federal Ministries of Economy and Technology, the Interior, for Work and Social Order and for the Environment, Nature Conservation and Nuclear Safety with the approval of the Federal Council . She's gem. Art. 5 of this V entered into force on 28 June 2002.

Section 1
Scope, definitions

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§ 1 Scope

This Regulation lays down the procedures for the collection, evaluation and defence of risks in the transport or in the operation of medical devices. Unofficial table of contents

§ 2 Definitions

For the purposes of this Regulation:

1.

"incident" means a malfunction, failure or alteration of the characteristics or performance or unobjection of the marking or instructions for use of a medical device which directly or indirectly leads to death or to a a serious deterioration in the state of health of a patient, of a user or of another person, may have led or could lead to a serious deterioration in the health of a patient,

2.

"corrective action" means a measure to eliminate, reduce or prevent the recurrence of a risk posed by a medical device;

3.

"recall" means a corrective measure to cause the return, exchange, rearmament or retrofitting, suspension or destruction of a medical device, or to provide users, operators or patients with instructions for the further safe operation of the product. the application or the operation of medical devices,

4.

"recommendation of measures" means a communication by the person responsible in accordance with § 5 of the Medical Devices Act, which will cause a corrective action to be taken,

5.

Serious adverse event of any unintended event occurring in a clinical examination subject to a permit or an approved performance assessment test, which event, directly or indirectly, leads to death or to an unintended event serious deterioration of the state of health of a person, a user or any other person, may have led or could lead without taking into account the fact that the event was caused by the medical device; In the event of serious adverse events occurring in the event of a a clinical trial or a performance assessment test for which exemption from the permit requirement has been granted in accordance with § 20 (1) sentence 2 of the Medical Devices Act.

Section 2
Notification of incidents and recalls

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§ 3 Reporting requirements

(1) The person responsible pursuant to § 5 of the Medical Devices Act has to report incidents that have occurred in Germany, as well as revocations carried out in Germany to the competent federal authority. He shall notify the competent authorities of other States Parties to the Agreement on the European Economic Area that they have been called upon to recall. Recalls which are also carried out in the European Economic Area on the basis of incidents that have occurred outside the European Economic Area shall be subject to reporting requirements. The reporting of such corrective measures, including the underlying incident, has to be made to the competent federal authority if the person responsible has its registered office in Germany according to § 5 of the Medical Devices Act. (2) Who Medical products employed or operated professionally or commercially, have to report any incidents which have occurred to the competent federal authority. The first sentence shall apply to doctors and dentists who are to be known in the context of the diagnosis or treatment of patients who are supplied with medical devices. (3) Who, without being responsible under § 5 of the Medical Devices Act, will be responsible for the treatment of medical devices. In the case of professional or commercial or in compliance with statutory tasks or obligations, medical products for self-application by patients or other lay persons to the end user, has informed the competent authority of the competent federal authority. report. In all other cases, distributors and dealers inform the person responsible according to § 5 of the Medical Devices Act about them communicated to them. (4) The obligations under paragraphs 2 and 3 shall be deemed to be fulfilled for members of the medical professions as as far as notifications are made to commissions or other institutions of the medical professions which, in the course of their tasks, cover the risks of medical devices, and there is ensured an immediate forwarding to the competent federal authority. (5) The examiner or the principal examiner has the sponsor of any serious (6) The sponsor has to report serious adverse events to the competent federal authority. This also applies if they have occurred outside of Germany. If a clinical trial is also carried out in other contracting states of the Agreement on the European Economic Area, the sponsor shall also notify the competent authorities there of serious undesirable effects on Germany which have occurred in Germany. (7) The competent federal authority shall certifying the person or body reporting in accordance with paragraphs 1 to 4 and 6 the receipt of the notification. It shall immediately inform the person responsible in accordance with § 5 of the Medical Devices Act of the reports referred to in paragraphs 2 to 4, which shall thereupon communicate a notification in accordance with paragraph 1 with all the necessary information or an explanatory statement as to why no information is available. An order within the meaning of Section 2 (1) is available or the conditions pursuant to § 4 are fulfilled. If the competent national authority does not comply with this statement, it may request a notification under paragraph 1. Unofficial table of contents

§ 4 Exceptions to the reporting obligation and special procedures

(1) The competent authority of the federal government may order exemptions from the reporting obligation or a summary report at regular intervals for already sufficiently investigated incidents. If the conditions set out in the first sentence are met, an exception to the obligation to notify may also be allowed at the request of the person responsible under Section 5 of the Medical Devices Act. (2) Incidents which have already been the subject of a recommendation of the measures of the Those responsible according to § 5 of the Medical Devices Act or an order of the competent authority were and can continue to perform, are from this in regular time intervals coordinated with the competent federal authority in individual cases to summarize. The content of the notification in accordance with the first sentence is agreed between the competent authority of the federal government and the person responsible according to § 5 of the Medical Devices Act. Unofficial table of contents

§ 5 Deadlines

(1) The controller according to § 5 of the Medical Devices Act has to report incidents according to the urgent need of the risk assessment to be carried out, but at the latest within 30 days after having received knowledge of this. In case of danger in default, the message shall be reported immediately. Recalls and incidents within the meaning of § 3 (1) sentence 3 shall be reported at the latest with the start of the implementation of the measures. (2) The notifications and communications pursuant to § 3 (2) to (5) and (6) sentence 3 shall be made immediately. This shall also apply to reports of serious adverse events for which a connection with the medical device to be tested, a comparison product or the therapeutic or diagnostic measures used in the clinical trial or the other conditions of the conduct of the clinical trial cannot be excluded. All other serious adverse events must be fully documented and reported in summary form on a quarterly basis or at the request of the competent federal authority. Unofficial table of contents

§ 6 Notification by distributor

To the extent that, on behalf of the person responsible pursuant to § 5 of the Medical Devices Act, reports are reported by a distributor resident in Germany, the provisions of § § 3 of the German Medical Devices Act (§ § 3) shall apply to those responsible for the medical products act. Up to 5 accordingly. Unofficial table of contents

§ 7 Modalities of the notification

(1) The Federal Ministry of Health makes the competent federal authorities, stating their areas of responsibility, their postal addresses and the telecommunications numbers of the competent authorities responsible for risk assessment and assessment. Organization units as well as information on accessibility outside the usual service hours on its website, and ensures a continuous updating of this notice. (2) The notifications pursuant to § 3 (1) and (6) shall be made electronically as a file in the original formatting. The competent federal authorities shall also disclose information on the electronic transmission of the other notifications, as well as the forms and sources of reference recommended for use, on their Internet pages.

Section 3
Risk assessment by the competent federal authority

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Section 8 Tasks of the Authority

The competent federal authority shall carry out a risk assessment for all of the incidents, recalls and serious adverse events to be notified to it pursuant to § 3. It has to carry out or have carried out scientific studies in order to identify possible risks. Unofficial table of contents

§ 9 The aim and content of the risk assessment

The aim and content of the risk assessment by the competent federal authority is to determine whether there is an unsafe risk and what corrective measures are required. If the controller meets self-responsible corrective measures in accordance with § 5 of the Medical Devices Act, the risk assessment by the competent federal authority shall include the examination as to whether these measures are appropriate. The second sentence shall apply mutatily to the sponsor's own responsible corrective actions or to those carrying out the clinical trial or performance assessment test. Unofficial table of contents

§ 10 Risk assessment procedure

The risk assessment shall be carried out in cooperation with the responsible person in accordance with § 5 of the Medical Devices Act and, where necessary, with the operators and users concerned. The risk assessment in the case of clinical trials or performance assessment tests shall include the cooperation with the sponsor or the head of the clinical trial or the performance assessment examination. Where necessary, the competent authorities of the Federal Government and of the Länder, the law enforcement authorities, the authorities of other States, the competent authorities of the Federal Republic of Germany and of the Federal States, the authorities of other States, the relevant authorities of the scientific societies, the Medical Service of the Association of the Federal Government of the Health Insurance Funds, notified bodies and other bodies, bodies, ethics committees and persons who, on the basis of their knowledge and knowledge, are Experience in answering specific questions can contribute. The competent federal authority shall, through appropriate organisational measures, ensure that particularly urgent cases are dealt with without delay. Unofficial table of contents

Section 11 Powers of the Authority

(1) The competent authority of the federal authority may, by the person responsible in accordance with § 5 sentence 1 and 2 of the Medical Devices Act and the group of persons referred to in § 3 (2), 3 and 5, all necessary for the factual information or the risk assessment. Information and documents as well as the transfer of the product concerned or samples of the product batch concerned, in the case of in vitro diagnostic medical devices, also the sample material affected by an incident, for examination purposes. Patient data shall be anonymized prior to the transmission to the competent federal authority in such a way that a personal reference can no longer be established. Other personal data may only be collected, stored, used and transmitted in so far as it is necessary for the performance of the tasks provided for in this Regulation. The competent federal authority may, in justified cases and in coordination with the competent authority, carry out product inspections and verifications of the production processes in the operation of the person responsible under Section 5 of the Medical Devices Act or in the case of the latter. (2) If a proper risk assessment is not possible due to insufficient involvement of the person responsible under § 5 of the Medical Devices Act, which has no seat in Germany, the competent authority shall inform the competent authorities of the competent authority. Federal authority, as far as necessary, operator and user, and can Recommend preventable measures. Unofficial table of contents

§ 12 Cooperative obligations

(1) The persons referred to in the first sentence of Article 11 (1) (1) shall support the competent federal authority in the performance of their duties in accordance with § 8 sentence 1 and shall provide the information requested. The party responsible for providing information may refuse to provide information on such questions, the answers to which he or she himself or one of his relatives, referred to in § 383 (1) (1) to (3) of the Code of Civil Procedure, of the risk of criminal prosecution or of a To suspend proceedings under the Law on Administrative Offences; it should be noted. In addition, provisions on the protection of personal data, legal confidentiality requirements and medical confidentiality remain unaffected. (2) The person responsible for the risk assessment in accordance with § 5 of the Medical Devices Act (Medical Devices Act) to carry out the necessary investigations without delay and to inform the competent federal authority of the results. It shall submit a final report to each report and, on request, all relevant documents, in particular relevant extracts from risk analysis and clinical evaluation. Prior to a destructive testing of the product concerned or the existing samples of the product batch concerned, the person in charge of the product must consult the competent federal authority in accordance with § 5 of the Medical Devices Act. (3) In the case of of clinical trials or performance assessment tests, the notification requirements referred to in paragraphs 1 and 2 shall apply in accordance with the sponsor, as well as the persons carrying out the clinical examination or the performance assessment test. (4) Users, Operators and auditors have to ensure that medical devices and Test materials suspected of being involved in an incident or having caused a serious adverse event shall not be discarded until the investigations have been completed. (5) The person responsible according to § 5 of the At the request of the competent federal authority, the Medical Devices Act shall make documents necessary for the declaration of facts and risk assessment electronically, provided that it is possible and reasonable for the competent authority. Unofficial table of contents

§ 13 Completion of the risk assessment

The competent federal authority shall communicate the result of its risk assessment to the person responsible in accordance with § 5 of the Medical Devices Act and the person who reported the incident or the serious adverse event, and in accordance with the conditions laid down by the § 20 to the competent authorities. The risk assessment by the Federal Supreme Authority has thus been completed. A new risk assessment may be required on the basis of new findings.

Section 4
Corrective measures

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Section 14 Corrective measures of the person responsible according to § 5 of the Medical Devices Act

(1) The responsible person in accordance with § 5 of the Medical Devices Act has to carry out the necessary corrective measures. In the selection of measures, it shall apply the principles of integrated security as laid down in the basic requirements of the relevant Directives. He has to take precautions to ensure that, if necessary, the recall of medical devices, from which unreasonable risks arise, can be carried out quickly and reliably. (2) The person responsible pursuant to § 5 of the Medical Devices Act has over Correct measures the other providers, the operators concerned and the users to inform in writing in German by means of a recommendation. These recommendations shall indicate whether a contact person or a contact point with indications of accessibility should be required to identify the products and product batches concerned in a clear and unambiguous manner for possible inquiries, the lack or absence of such products or the product batches. to describe the identified malfunction and, where known, its cause, the risk arising from the products and the facts and considerations on which the evaluation is based, and to provide the necessary information to the extent necessary to ensure that the necessary information is provided. unequivocally pretend corrective action. Further information may be provided in so far as they are useful. The responsible persons in accordance with § 5 of the Medical Devices Act must ensure the correct implementation of the measures referred to in paragraph 1. and to verify their effectiveness. The implementation and the verifications must be documented. (4) The competent authority supervises the measures implemented by the controller in accordance with § 5 of the Medical Devices Act. (5) Insofar as corrective measures are carried out on behalf of the responsible person. § 5 of the Medical Devices Act shall be carried out by a distributor established in Germany, the provisions of paragraphs 2 to 4 shall apply accordingly. Unofficial table of contents

Section 14a Responsible corrective actions of the sponsor of clinical trials or performance assessment tests

(1) In the course of the clinical trial or the performance assessment test subject to authorisation, circumstances which may affect the safety of the subjects, users or third parties shall be taken by the sponsor as well as the clinical trial (2) The sponsor shall immediately inform the person, user, or third party of any necessary security measures to protect the subjects, users or third parties against immediate or indirect danger. competent federal authority and shall arrange for the information to be provided to (3) The competent authority shall monitor the activities carried out by the sponsor. Unofficial table of contents

Section 15 Measures taken by the competent authorities

To the extent that a person responsible under § 5 of the Medical Devices Act does not take the necessary corrective measures on his own account or if the measures taken are not sufficient, the competent authority shall take the necessary measures against the Responsible according to § 5 of the Medical Devices Act or the distributors established in Germany. This shall apply to the sponsor or to the persons carrying out the clinical trial or the performance assessment test. Unofficial table of contents

Section 16 obligation to participate in the corrective measures

The group of persons referred to in § 3 (2), (3) and (5) shall participate in the corrective measures in accordance with the measures recommended by the person in charge pursuant to § 5 of the Medical Devices Act or by order of the competent authorities. Authority issued. This shall apply in accordance with recommendations of the sponsor of the clinical trial or the performance assessment test. Unofficial table of contents

Section 17 Measures taken by the competent authorities against operators and users

Insofar as a sufficient risk minimisation is not or cannot be achieved sufficiently quickly by measures in accordance with § § 14 and 15, the competent authorities shall take the necessary measures to ensure that the operation or application of the to prohibit or restrict affected medical devices. Unofficial table of contents

Section 18 Emergency planning of the competent authorities

The competent authorities shall inform the Federal Ministry of Health and the competent federal authorities of the availability outside of the usual service hours. The Federal Ministry of Health is aware of the availability in the Federal Gazette and ensures a continuous updating of this notice.

Section 5
Teaching obligations and information exchange

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Section 19 Information of the Federal Ministry of Health by the competent federal authority

The competent federal authority shall inform the Federal Ministry of Health without delay of all incoming reports concerning incidents of death or other particularly important events. In addition, it shall inform the Federal Ministry of Health of all corrective measures concerning products in Germany in the field of transport or in operation. Unofficial table of contents

§ 20 Exchange of information between the competent federal authority and the competent national authorities

(1) The competent federal authority shall inform

1.

the person responsible for the seat of the person responsible pursuant to § 5 of the Medical Devices Act or, if the person responsible is not established in Germany and a distributor established in Germany is known, the distributor and the person responsible for the location of the the competent supreme state authority or the competent authority designated by that competent authority for incoming reports of incidents and recalls, and of the conclusion and outcome of the risk assessment carried out,

2.

the seat of the sponsor or his representative pursuant to Section 20 (1) sentence 4 (1a) of the Medical Devices Act, or, if the latter is not established in Germany, those for the examination offices in Germany and those for the place of serious undesirable event or the competent authority designated by that designated competent authority for detailed reports of serious adverse events, the conclusion and the outcome of the risk assessment carried out.

The information may also be provided in such a way that the German Institute for Medical Documentation and Information informs the competent authority that new data for them pursuant to § 29 (1) sentence 4 of the Medical Devices Act are available for retrieval. shall be kept ready. If the person responsible under § 5 of the Medical Devices Act or the sponsor is not prepared to carry out the necessary corrective measures on its own responsibility, the competent federal authority shall inform the competent authority of the risk assessment for the (2) The competent authority shall inform the competent authority of the competent authority of all the measures taken, and shall inform them of the progress and conclusion of the measures. It also informs the competent federal authority if it does not share the assessment of the risk. (3) The Federal Institute for Drugs and Medical Devices conducts regular meetings in coordination with the Paul-Ehrlich-Institut. (routine sessions) with the top federal and state authorities responsible for medical devices as well as the competent authority according to § 15 of the Medical Devices Act on the basics and the procedure of risk assessment and assessment as well as cases of General interest. For specific questions, the competent federal authority can invite you to a special meeting. Where appropriate, the medical service of the top associations of the health insurance companies, representatives of the medical professions and hospitals, the associations of the medical device industry as well as other relevant authorities and organisations should be involved. Unofficial table of contents

Section 21 European and international exchange of information

(1) The competent federal authority shall inform the competent authorities of the other Contracting States of the Agreement on the European Economic Area and the European Commission and on the basis of agreements or agreements, or Administrative arrangements or, on request, the competent authorities of other States, as a result of an incident, or deemed necessary, corrective measures to be taken, including information on the underlying Events. On request, it shall also provide information and information on available notifications and risk assessments carried out. In the case of corrective measures according to § 14, if no request is made, a notification may be left if it does not constitute a relevant gain in knowledge for the recipient in view of the proper functioning of the task. Section 11 (1) sentence 2 shall apply. (2) The competent federal authority shall direct the competent authorities of the other States Parties to the Agreement on the European Economic Area and other States, as well as from international Organisations received notifications of corrective actions carried out or deemed necessary for the purpose of checking for plausibility to the persons responsible for the seat of the person responsible pursuant to Section 5 of the Medical Devices Act or, if the The person responsible for his/her seat is not in Germany and a resident of Germany The distributor shall be known to the distributor or the competent authority designated by that competent authority. If the person in charge of the German Medical Devices Act (§ 5 of the German Medical Devices Act) does not have his registered office in Germany and a distributor established in Germany is not known, the competent federal authority shall decide in accordance with the circumstances of the respective The competent national authority shall inform the competent authorities of the other Contracting States of the Agreement on the subject of the European Economic Area and the European Commission on the grounds of Safety of rejected, suspended or terminated clinical trials, as well as on major changes or temporary interruptions of clinical trials. The provisions of Section 22a (6) sentence 2 and 3 of the Medical Devices Act shall apply accordingly. Unofficial table of contents

Section 22 Information of other authorities, organisations and bodies

(1) The competent federal authority shall inform the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety of incoming reports of incidents and recalls, as well as of the conclusion and outcome of the operations carried out. Risk assessments, insofar as radiation protection is concerned, and the Robert Koch Institute, insofar as medical devices are affected, which are intended for disinfection purposes. (2) The competent federal authority shall inform the Federal Ministry of Defense, the competent authority according to § 15 of the Medical Devices Act and the in the notified body designated for incoming notifications of incidents and recalls, as well as the conclusion and the outcome of the risk assessments carried out. The information may also be provided by granting access to the data provided by the German Institute for Medical Documentation and Information in accordance with § 29 (1) sentence 4 of the Medical Devices Act for central processing and use (3) Information and information on available reports, risk assessments carried out and corrective measures may also be sent to the Medical Service of the Association of the Federal Government of the Health Insurance Funds, the German Federal Government, hospital company and other organisations, bodies and persons, (4) § 11 (1) sentence 2 shall apply. (5) If the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) is part of a Consultation procedure laid down in Annex II (4.3) and III (paragraph 5) of Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 327, 30.4.1993, p. 1), as last amended by Article 2 of Directive 2007 /47/EC (OJ L 378, 27.12.2007, p. 21), or in accordance with Annex 2 (paragraph 4.3) and Annex 3 (paragraph 5) of Council Directive 90 /385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable implantable devices medical equipment (OJ L 327 17), which was last amended by Article 1 of Directive 2007 /47/EC (OJ L 189, 20.7.2007, p. 21), has been amended in the current versions and subsequently receives information on the complementary substance used, the effects on the benefit/risk profile of the use of this substance in the In this way, the notified bodies concerned shall inform the interested parties of the medical product. The notified body shall examine whether this information has an impact on the benefit/risk profile of the use of the substance in the medical device and, where appropriate, shall initiate a re-evaluation of the conformity assessment procedure. Unofficial table of contents

Section 23 Scientific work-up of the risk assessments carried out

The competent federal authority carries out a regular scientific review of the risk assessments carried out and announcates the results. Personal data is to be anonymized. Unofficial table of contents

§ 24 Publication of information on the Internet

The competent authority of the federal government can inform about the correct measures, recommendations and results of the scientific work-up according to § 23 on the website of the authority. The information on corrective measures may not contain any personal data in addition to the information provided for in § 14 (2) sentence 2 as well as the persons designated as representative in the commercial register as representative. Unofficial table of contents

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