Medizinprodukte-Anwendermelde- und Informationsverordnung – MPAMIV
The Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) replaces the Medizinprodukte-Sicherheitsplanverordnung (MPSV).
What new requirements does the MPAMIV establish for manufacturers and operators? What effects will these requirements have on their internal procedures, e.g., their QM systems?
Knowledge of the regulatory requirements is important because the authorities aren’t very accommodating when it comes to reporting.
But it’s not just about avoiding painful fines, it’s also about ensuring patient safety.
1. Why the Medizinprodukte-Anwendermelde- und Informationsverordnung is needed
The current Medizinproduktegesetz (MPG) obliges manufactures – or more precisely their safety officers – “to collect and evaluate existing information concerning risks connected to medical devices and shall co-ordinate the necessary measures.” The details are regulated by the Medizinprodukte-Sicherheitsplanverordnung.
Therefore, the legislator has no option but to adapt the national regulations that govern just how the laws are implemented. There are several ways this can be done:
- Replacing existing national regulations with new national regulations
- Amending existing national regulations
- Repealing existing national regulations and incorporating the contents into law
In the case of the Medizinprodukte-Betreiberverordnung, the legislator has gone for the second option and, in the case of the Medizinprodukte-Sicherheitsplanverordnung, for the first.
As a result, the MPSV is being replaced by a new Medizinprodukte-Anwendermelde- und Informationsverordnung – MPAMIV.
The full title of the MPAMIV is “Verordnung über die Meldung von mutmaßlichen schwerwiegenden Vorkommnissen bei Medizinprodukten sowie zum Informationsaustausch der zuständigen Behörden.”
2. Who the Medizinprodukte-Anwendermelde- und Informationsverordnung affects
The MPAMIV affects:
- Authorities (BfArM/PEI and state authorities) and the ministry
- Medical device (including in-vitro diagnostic medical device) operators
- Coroners and pathologists
- Manufacturers of medical devices (from the date the MDR enters into effect)
- Manufacturers of in vitro diagnostic medical devices (from the date the IVDR enters into effect)
3. What the MPAMIV requires
The Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) contains 13 paragraphs divided into two sections. The first establishes when reports of “suspected serious incidents” should be sent and to whom, the second how the authorities should coordinate among themselves.
a) MPAMIV requirements for operators
- Report “suspected serious incidents” via information system (§86 MPDG) to the higher federal authority (§3)
b) Requirements for manufacturers
- Create photographic documentation of the device before its unavoidable destruction (§7)
c) Requirements for the authorities and the Federal Ministry of Health
- Publish reports on websites (§6)
- Acknowledge receipt of reports (§6)
- Decide on need for action, evaluate manufacturer’s actions (§7)
- Inform the reporting person of the manufacturer's actions and their own risk assessment (§7)
- Exchange information between one another (§8 et seq.)
- Communicate availability (§12)
- Publish recommendations (§13)
d) Requirements for other people
- Patients: report “suspected serious incidents” to physicians or higher federal authority (§5)
- Coroners, pathologists: report “suspected serious incidents” to physicians or higher federal authority (§4)
4. What exactly should manufacturers do now?
a) Study all the regulatory requirements
In contrast to the MPSV, the Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) only contains a few requirements that affect manufacturers. However, this should not make manufacturers think there are fewer requirements. It’s just that these requirements can now only be found elsewhere!
Relevant regulatory requirements
Vigilance requirements can be found, for example, in the following documents:
- MDR, e.g. article 87et seq.
- MPDG, particularly chapter 5 (§71 et seq.)
- EU/MEDDEV guidances including the
- Manufacturer Incident Report 2020 (PDF form)
- Corresponding Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form
- “Helptext” (Excel file indicating which information is mandatory and when)
- IMDRF categorization codes
b) Adapt their processes
The MPAMIV should not be the trigger for manufacturers to start adapting their vigilance processes. The MDR and the MPDG should have already triggered these changes.
Manufacturers should pay attention to the following when revising their processes:
- The safety officer has been replaced by the “responsible person .” But this means more than just having to switch the two terms in standard operating procedures using “search and replace.” The requirements and activities are not the same.
- The interplay between post-market surveillance and vigilance may have to be redefined.
- The MDR sets slightly different reporting deadlines than the MPSV.
- Manufacturers should review their own specifications with regard to the report content and form, as well as who the reports are sent to.
c) Prepare IT systems
The EU and national authorities are increasingly requesting that (“suspected”) serious incident reports are sent electronically.
- The BfArM provides/provided forms for this purpose.
- These forms are being replaced by the EU’s MIR (see above).
- As soon as EUDAMED is available, manufacturers will have to send their reports electronically there.
Manufacturers would be well advised to check whether they can simplify the sending of this information through their own systems. This is especially the case when they:
- market a lot of devices
- and in a lot of EU countries.
- have complex economic operator competencies.
- already operate a system for managing reports and documenting actions.
5. Criticism of the MPAMIV
a) Unnecessary extension of the MDR
The MPAMIV introduces the term “suspected serious incident”:
Definition: suspected serious incident
“Incident with respect to which it cannot be ruled out that it was caused by an undesirable side-effect of a device, a malfunction, or deterioration in the characteristics or performance of a device, including use-error due to ergonomic features or an inadequacy in the information supplied by the manufacturer and directly or indirectly led or might have led to any of the following:
- the death of a patient, user or third party
- the temporary or permanent serious deterioration of a patient's, user's or other person's state of health
- a serious public health threat”
Spektaris criticizes the fact that the additional definition of a “suspected serious incident” is an extension of the term “serious incident” as defined by the MDR.
This “means any incident that directly or indirectly led, might have led or might lead to [...]”
As Spektaris notes, proving that something can be ruled out is difficult and having to do so will lead to a lot of "irrelevant reports.”
b) Inadequate reporting requirements
Both Spektaris and the “Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF, Association of the Scientific Medical Societies in Germany)” criticize the reporting obligation in its current form. They argue that the BfArM does not have sufficient resources and that this obligation goes beyond the demands of the MDR.
The AOK recommends replacing the obligation with a “should.”
c) Investigation and final report: unclear expertise
Investigations by the federal authorities are generally welcomed. The AOK wants health insurance companies to be systematically informed of them. The AWMF does not seem to be sure that the authorities have the necessary expertise in all cases.
d) Additional criticism
There is a lot vagueness that can be criticized. For example:
- No definition of what a “beauftragter Sachverständiger” [commissioned expert] is
- The use of the term “Vertreiber” [distributor] rather than “Händler” [distributor] or “Wirtschaftsakteure” [economic actor]
6. Summary and conclusion
a) A short regulation
Little has remained of the Medizinprodukte-Sicherheitsplanverordnung. The new Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) is surprisingly lean at 14 paragraphs and establishes few requirements for manufacturers.
b) Integrity is required
Nevertheless, manufacturers should take into account the vigilance requirements that are now found in other regulations.
They should also be aware that “sweeping incidents under the carpet” is not just illegal, it is more likely to be discovered in the future. Not least because the draft of the Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) doesn’t just require operators to send reports to the higher federal authority, it also requires patients and coroners to do so.
Once again, manufacturers have to act with integrity: when developing safe medical devices and by being transparent and reporting any incidents that do occur.
The vigilance requirements have always been spread across several documents. Whereas before manufacturers had to study the MPG, MPSV, MDD and the MEDDEV documents, now they have to study the MPDG, MPAMIV, MDR, MEDDEV and IMDRF documents.
So that this does not become a problem for their own employees, manufacturers should clearly describe the procedure in the event of an incident in standard operating procedures to ensure that they comply with all regulatory requirements. They need to call on their “Regulatory Affairs” and “Quality Management” departments.
The Johner Institute helps manufacturers set up lean and easy-to-understand systems for post-market surveillance and vigilance, and can also manage these processes in full or in part if requested.
Write to us now, e.g., via our contact page.