Paul-Ehrlich-Institut

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IVD Vig­i­lance

Competent Higher Federal Authority for the Safety of In Vitro Diagnostic Devices (IVD)

The Paul-Ehrlich-Institut has been the competent higher federal authority for the centralised collection and assessment of serious risks of certain IVDs since 1 January 2002.

With the entry into force of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) on 26 May 2022, the competence of the Paul-Ehrlich-Institut expanded to all products that fall under classification rules 1, 2, and 3 (a) to (e) and (g) of Annex VIII of the IVDR. These are all class D products (life-threatening infections, pathogens transmissible through blood and tissue) and some of the class C products (e.g. sexually transmitted agents).

The legal basis for the tasks of the Paul-Ehrlich-Institut in the field of IVD vigilance can be found in the IVDR, the Medical Device Law Implementation Act (MPDG), and the Medical Devices User Reporting and Notification Ordinance (MPAMIV).

Responsibilities

The Paul-Ehrlich-Institut's responsibilities in the field of IVD are defined in section 85 subsection 3 sentence 1 of the MPDG.

The tasks assigned to the Paul-Ehrlich-Institut in accordance with section 85 subsection 3 sentence 1 number 1 of the MPDG are carried out by the BTC, ATMP and IVD Vigilance Division.

Central among these tasks is the recording, evaluation and assessment of IVD risks, such as the evaluation of incident reports. These are reports of events involving products that are already on the market.

The Paul-Ehrlich-Institut receives these reports from users (e.g. blood donation facilities, diagnostic laboratories, private individuals) or the manufacturer of the IVD. The Paul-Ehrlich-Institut carries out a risk assessment of the incident and assesses the usefulness of corrective or preventive measures taken by the IVD manufacturer. In the case of national IVD manufacturers, the Paul-Ehrlich-Institut may propose further corrective measures to the competent state authority responsible for monitoring the product. The state authorities are empowered to mandate these recommendations if necessary and to monitor their implementation. In the case of incident reports requiring corrective action in several EU Member States, the Paul-Ehrlich-Institut assumes a coordinating role in order to ensure a uniform approach throughout Europe.

IVDs under the responsibility of the Paul-Ehrlich-Institut

According to section 85 subsection 3 sentence 1 number 1 of the MPDG, the Paul-Ehrlich-Institut's responsibilities for the tasks referred to in section 85 subsection 2 sentence 1 numbers 2-14 of the MPDG is limited to IVDs that fall under Rules 1, 2 and 3 (a) to (e) and (g) of Annex VIII to Regulation (EU) 2017/746.
In all other respects, pursuant to section 85 subsection 2 of the MPDG, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the tasks assigned to higher federal authorities in the IVD area.

Reporting obligations and reporting deadlines

Reporting obligations to the higher federal authorities in connection with IVD vigilance

Manufacturers of products made available on the Union market are subject to the following reporting obligations:

  • Reporting of serious incidents pursuant to Article 82 of the IVDR
  • Reporting of field safety corrective measures pursuant to Article 82 of the IVDR
  • Reporting of trends pursuant to Article 83 of the IVDR
  • Manufacturer's final report, field safety instructions pursuant to Article 84 of the IVDR

The reporting deadlines for reporting a serious incident are set out in Article 82 paragraphs 2-5 of the IVDR. The reporting period depends on the severity of the serious incident.

As a general rule, serious incidents must be reported immediately after a causal relationship or a possible causal relationship between the incident and the product has been established, but not later than 15 days after the manufacturer becomes aware of the incident.

In the event of a serious danger to public health, the report must be made immediately, but not later than two days after the manufacturer becomes aware of the danger.

In the event of death or an unanticipated serious deterioration in a person's state of health, the report must be made immediately after the manufacturer has established a causal link between the product and the serious incident or as soon as they suspects such a link, but not later than ten days after the manufacturer becomes aware of the serious incident.

Field safety corrective actions shall be reported without undue delay before the field safety corrective action is undertaken, except in cases of extreme urgency where a field safety corrective action must be undertaken immediately (Article 82 paragraph 8 of the IVDR).

Importers and distributors must inform the higher federal authorities in the event of the acceptance of a serious risk posed by the product, section 81 number 1 of the MPDG in conjunction with Article 13 paragraph 2 subparagraph 2 and paragraph 7, Article 14 paragraph 2 subparagraph 2 and paragraph 4 of the IVDR. If the product has already been placed on the market or made available on the market, the report must be made immediately.

Anyone who operates or uses products professionally or commercially must immediately report any suspected serious incidents to the competent higher federal authority pursuant to section 3 sentence 1 of the MPAMIV. This obligation applies accordingly to doctors and dentists who become aware of suspected serious incidents in the course of their professional activities, pursuant to section 3 sentence 2 of the MPAMIV.

Patients or their relatives are not obliged to report to the higher federal authority, but they should inform the treating physician or dentist or the retailer who provided the product about suspected serious incidents with products that have affected them. You can also report suspected serious incidents directly to the competent higher federal authority, pursuant to section 4 of the MPAMIV.

Definitions of important terms in the field of IVD vigilance

Incident (Article 2 No. 67 IVDR)

An incident means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.

Serious incident (Article 2 No. 68 IVDR)

A serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • a) the death of a patient, user or another person,
  • b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
  • c) a serious public health threat.

Alleged serious incident (section 2 MPAMIV)

An alleged serious incident means an incident for which one of the following causes cannot be ruled out: an undesirable side effect of a product, a malfunction, or a deterioration in the properties or performance of a product, including use errors due to ergonomic features or an inadequacy of the information provided by the manufacturer and that directly or indirectly had or could have had any of the following consequences:

  1. the death of a patient, user or another person,
  2. the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, or
  3. a serious public health threat.

Serious public health threat (Article 2 No. 69 IVDR)

A serious public health threat means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.

Corrective action (Article 2 No. 70 IVDR)

A corrective action means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.

Field safety corrective action (Article 2 No. 71 IVDR)

A field safety corrective action means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

Field safety notice (Article 2 No. 72 IVDR)

A field safety notice means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

Updated: 28.08.2023