Monday 9 September 2019
Two new laws are in store for you in Germany:
The Medizinprodukte-Anpassungsgesetz-EU (MPAnpG-EU) has been available since 25 August 2019 as a ministry draft, which you can see under this link.
In Article 1 the MPAnpG-EU describes the Medizinprodukte-Durchführungsgesetz (MDG) and in the subsequent articles, other legislative amendments.
Please note: the Medizinprodukte-Durchführungsgesetz (MDG) is to replace the Medizinproduktegesetz (MPG) and so will be binding in Germany for all manufacturers and operators of medical devices, as well as other stakeholders.
Does that sound like a lot of laws and red tape?
This article will give you an initial insight and tell you what you as a medical device manufacturer need to bear in mind to avoid the sanctions and monetary fines set out in extended provisions. It also includes a PDF to download, which compares the MDG and MPG so that the changes are easier to identify and respond to.
The current Medizinproduktegesetz converts (or converted) the requirements of EU guidelines such as the MDD and the IVD to national law. In contrast, the MDR and IVDR, like all EU regulations, do not require any such conversion. They are already statutory.
However, national guidelines are required that regulate, for example:
the responsible authorities in the corresponding country
sanctions such as custodial sentences and fines (this is a concern for the nation states)
specific requirements in the corresponding country, which must not contradict the EU regulations or prevent competition
The Medizinprodukte-Durchführungsgesetz MDG and (future) national regulations take these specifications in hand. The MDG is available as part of the MPAnpG-EU as a ministry draft, however, the regulations are not yet available.
As mentioned above, the Medizinprodukte-Anpassungsgesetz-EU (MPAnpG-EU) contains the MDG, which is to replace the MPG. Furthermore, the MPAnpG-EU sets out amendments to eight further laws such as
the German Social Code (SGB), Book Five
the law on competition in the area of healthcare and
the law on the circulation of pharmaceutical products.
These changes are, however, marginal and adapt references that have become invalid, to the EU guidelines in particular.
Almost half of the 163-page ministry draft contains explanatory statements.
The MDR and IVDR already specify the legal framework. For this reason, in contrast to the MPG, the MDG no longer contains a lot of specifications like the conformity assessment procedures. However, with approx. 21,000 words, the MDG is clearly more extensive than the MPG (just under 16,000 words). This is also clear from the number of paragraphs, which has notably increased from 44 to 69.
Like the MPG, the Medizinprodukte-Durchführungsgesetz MDG is divided into nine “chapters”, which the MPG calls “sections”. The direct comparison in the article shows that above all there are clearly more sections on clinical trials, vigilance and transitional provisions.
The MDG leaves custodial sentences unchanged at three to five years. However, the law threatens those who bring counterfeit products into circulation with custodial sentences. It is also new that commercial or gang violations are explicitly mentioned and can be sanctioned with up to five years of imprisonment.
In the list of actions subject to custodial sentences, the following are new or have been included in more detail:
starting and continuing clinical trials and performance reviews contrary to several articles of the MDR or IVDR
bringing products into circulation without registering them or the manufacturer
making misleading statements
The MDG has also extended the list of monetary fines; however, the maximum fine has been kept at 30,000 EUR.
It is worth noting that the Medizinprodukte-Durchführungsgesetz no longer acknowledges safety officers. Correspondingly, the requirement “only” states, for example, that the manufacturer must provide notification of “corrective safety measures”, but not that this is the duty of a specific role, that is to say the safety officer.
There is also no indication that the “qualified person” according to Article 15 MDR must assume the duties of the safety officer. Correspondingly, the MDG only contains references to Article 15 under the provisions on the payment of fines.
The requirements regarding medical device advisers have been maintained in the Medizinprodukte-Durchführungsgesetz MDG. This also applies to the required expertise.
The chapter in the MDG that stipulates how manufacturers are to apply for, start, perform and monitor clinical trials, now has a greater scope and partly goes beyond the requirements of the MDR, as you will see in the next paragraph.
Just like the MPG, many chapters of the MDG set out the responsibilities and rights of the individual authorities.
Contrary to what its name suggests, the Medizinprodukte-Durchführungsgesetz MDG not only regulates the implementation of the MDR or IVDR, but to some extent also imposes additional requirements such as:
clinical trial requirements must also be adhered to if the studies are not conducive to proving the purpose, safety and performance of the products, but new scientific findings. This is regulated by the MDG in more detail than the MDR. Please refer to our article on clinical trials;
businesses that sterilise or rehabilitate medical devices with a low microbial count for others must also register with the authorities. This also applies to companies that manufacture implantable class III custom-made products;
the accompanying materials must be written in German. Exceptions are allowed in the case of professional operators (English);
it is forbidden to manufacture, store, bring into circulation and put into operation counterfeit products, counterfeit accessories and counterfeit parts and components;
demonstration devices must be explicitly identified if they do not meet the regulatory requirements;
in the event of a dispute between a manufacturer and authorised body regarding classification, the higher federal authority shall adjudicate;
even in the case of less critical products, the MDG obliges manufacturers not to start clinical trials until they have the approval of the higher federal authority;
the MDG sets the bar higher than the MDR for clinical trials on special test subjects (minors, those who are unaware of what is going on, prisoners, etc.);
it also describes the interaction with the ethics committee and its approach in more detail; and
personal data gathered during clinical trials must be pseudonymised by the investigator prior to forwarding.
Companies that manufacture or bring medical devices into circulation in Germany, companies that perform clinical trials or those who only act as a sterilisation service provider, must study the MDG. This is a painstaking task as they must glean the requirements from two sources – the MDG and the regulations. There is no consolidated list of requirements.
Particularly in the case of clinical trials, including ethics commission requests, this means studying the law in detail and not giving in to the misconception that MDR conformity is enough.
Manufacturers would be wise to verify or revise their procedure specifications in order to conform to the Medizinprodukte-Durchführungsgesetz. This particularly applies to procedure specifications for:
registration of manufacturers and products
It is still too early to decide whether safety officers can be released from their role on 26/05/2020. However, it is not too early to establish the “qualified person” in accordance with Article 15. In doing so, ensure that their range of duties and other competencies differ from those of a safety officer.
Simply changing the name of the role entails the risk of non-conformity with the statutory requirements.
Just a few months before the MDR comes into effect, the Federal Ministry of Health has produced a ministry draft for the Medizinprodukte-Durchführungsgesetz MDG. This at least gives manufacturers and operators an idea of how the final law will look and enables them to prepare for it.
The fact that this ministry draft has come so late and with such an extensive scope will further confirm the opinion that: Germany (and Europe) does not establish any good framework conditions to enable manufacturers to remain competitive in the market. Resources required to handle red tape are lacking for innovation.
The excuse that Germany is only implementing specifications from Brussels with this law is unrealistic: Germany voted for the EU regulations in Brussels.