NAKI - The German National Working Group on the MDR and IVDR

The German Federal Ministry of Health has created the National Working Group (NAKI [Nationalen Arbeitskreis]) to answer questions on the implementation of the EU regulations, the MDR and the IVDR.

Even though the NAKI is a German working group, some of the results of its work will be of interest for other countries as well.

The conclusion at the end of this article provides an assessment of NAKI’s work so far.

Objectives of the NAKI

The NAKI has several objectives:

1. Creating a uniform understanding of how the MDR and IVDR will be implemented in Germany across all the parties involved (e.g., regulatory authorities, notified bodies, industry)
2. Answering open questions on the interpretation and implementation of the EU regulations and making these answers available to the general public
3. Supporting the national adaptations of the EU regulations and their implementation into national laws, in particular the adaptation of the German Medical Devices Act (MPG)

Members of the NAKI

The National Working Group is composed of the following participants under the management of the Federal Ministry of Health:

• Federal ministries
  • Federal Ministry of Health (BMG)
  • Federal Ministry of Economics and Technology (BMWi)
  • Federal Ministry of Education and Research (BMBF)
  • Federal Ministry of Defense (BMVg)
• Regulatory authorities
  • Federal Institute for Drugs and Medical Devices (BfArM)
  • Paul Ehrlich Institute (PEI)
  • German Institute of Medical Documentation and Information (DIMDI)
  • Robert Koch Institute (RKI)
• 8 supreme state authorities and the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG)
• 12 manufacturers’ associations and companies
• Community of Interest of Notified Bodies for Medical Devices in Germany (IG-NB)
• Federal Association of Pharmaceutical Wholesalers (PHAGRO)
• German Hospital Association (DKG)
• German National Association of Statutory Health Insurance Funds
• German Coalition for Patient Safety (APS)
• Association of the Scientific Medical Societies in Germany (AWMF)

NAKI working groups

The National Working Group (NAKI) has divided its tasks into several working groups (subgroups):

• Subgroup 1: Transitional provisions
• Subgroup 2: Notified bodies
• Subgroup 3: Manufacturer obligations
• Subgroup 4: Market surveillance
• Subgroup 5a: Classification/distinction
• Subgroup 5b: Vigilance system
• Subgroup 6: Clinical evaluation/clinical investigations
• Subgroup 7: Reprocessing

These working groups meet every so often and publish both the meetings and the results of the meetings on the NAKI’s website.

Selected NAKI work results

Subgroup 1 - Transitional provisions

Subgroup 1 has presented the most detailed results so far. Its FAQs answer 22 questions. For example, the NAKI clarifies that class I devices (not I*) must meet the requirements of the MDR without further transition periods from May 2020 in order to be marketed for the first time.

Other issues include the reclassification of devices and “substantial modifications”. A comprehensive answer as to when a modification is considered substantial has still not been given by the authors. However, they give examples of cases where an answer is possible:

• Change of intended purpose > substantial modification
• Limitation of the intended purpose > no substantial modification
• Design change due to corrective action > no substantial modification

The clarification that some of the MDR’s requirements must also be met if the device is marketed within the transition periods is also helpful:

• Registration of economic operators in EUDAMED
• Post-market surveillance
• Vigilance

Subgroup 3 (Manufacturer obligations)

Subgroup 3 of NAKI answers 10 questions in its FAQs on manufacturer obligations, including on the following topics:

• Information in the instructions for use and on the website
• PLM and OEM: This construct will no longer exist in its present form.
• Performance evaluation of IVDs

Subgroup 4 (Market surveillance)

The publication from NAKI subgroup 4 is relatively long at 26 pages. However, the results are not yet consistently helpful:

• In some cases, the authors only comment, for example, on the challenges in interpreting the MDR - without providing their interpretation.
• They ask a lot of new questions without answering them.

Overall, this document still looks like a work in progress. It defines the issues without dealing with them to an extent that gives manufacturers sufficient guidance.

Subgroup 6 (Clinical evaluation/clinical investigations)

Subgroup 6 answers nine questions in its FAQs. As expected, important questions, such as how to define what “sufficient clinical data” is, are not answered by the FAQ.

The argument that “similar devices” have to be monitored for the post-market clinical follow-up but only “equivalent devices” have to be included in the clinical evaluation is interesting. The NAKI subgroup makes it clear that much higher demands are made for the equivalence of comparator devices in terms of demonstrating the safety, performance and benefit of medical devices in the context of the clinical evaluation than in the context of post-market surveillance. In this case, the manufacturers have to monitor a broader product portfolio.

The FAQs look at clinical investigations in more detail than clinical evaluations.

Other subgroups

Subgroup 2 (notified bodies) has prepared a presentation.

Subgroup 5a (classification/distinction) has not published any results at the time of this article. The same is true for subgroup 5b (vigilance system).

We are also waiting for results from subgroup 7 (reprocessing).

Conclusion

The approach is to be welcomed

The MDR and IVDR are not characterized by their high level of comprehensibility. It is extremely regrettable that numerous working groups are required to reach an understanding as to how the EU regulations should be understood. There is also a lack of guidance and conclusive understanding of how the EU member states should implement these regulations in their national law.

For these two reasons, we should welcome the fact that the parties involved are getting together to reach a common understanding and work out a coordinated approach to the implementation of the MDR and IVDR, in Germany at least.

Lack of binding advice

On the other hand, the results from the NAKI working groups only provide another interpretation. According to their own statement, their results “only reflect the results of the discussions so far [...] and are therefore not legally binding”. If these results are then further weakened in terms of their binding force by statements such as “according to today's predominant opinion [...]”, we have to question the usefulness of the results.

Fortunately, the authors also make clear statements such as “blacking out parts of the technical documentation or making them unreadable in a way that, for example, affects the intellectual property of the OEM, is not permissible.” This is precisely the clear information that manufacturers need in order to make decisions.

Heterogeneous reporting

The NAKI working groups seem to have a high degree of freedom as to how they deliver the results of their discussions. Some have published an FAQ, others an interpretation of individual articles. This makes it harder for manufacturers to consolidate the results.

Coverage of topics is still incomplete

It is obvious that NAKI working groups that only meet occasionally cannot answer all the questions. The Johner Institute, which answers questions free of charge every day (several thousand questions so far) and publishes a lot of answers here on its website, cannot do this either.

Nevertheless, it must be hoped that NAKI will deal with issues, such as questions on EUDAMED and UDIs, very soon and in greater detail.

Missing or late publication

Another problem is when the results of the work and the national laws and regulations are published. Some working groups have not yet produced any specific results, others have raised more questions than they have answered.

This does not give manufacturers and other economic actors sufficient lead time and binding information to prepare for the transition to the EU regulations without any problems. This is precisely the type of support we would have liked from the legislator and regulatory authorities.

Regret and thanks to the NAKI

It is very regrettable that an understanding of how the legal requirements should be understood and implemented can only be achieved step-by-step. How can it be that the legislator itself first has to work out how laws should be interpreted?

This gradual acquisition of knowledge prolongs the uncertainty, causes unnecessary expenditure, and is damaging to Germany and Europe as a business location.

This regret explicitly does not refer to the people who work at the NAKI, answer questions and publish these answers. After all, these are the very people who are helping to improve this less-than-satisfactory situation through their contribution.

Thank you for your commitment!