What is the system?

Warning in advance, this section will be technical-legal, stay with me...

At the moment, the legislation you are dealing with is a European directive or directive (98/79/EG or IVDD). This directive came into effect in 1998 to ensure that the same guarantees of (medical) quality can be guaranteed within Europe. However, guidelines do not have direct effect on citizens and businesses, this requires action by national legislators. The Netherlands has complied with the IVDD by means of the Dutch Medical Devices Act.

At a certain point, the choice was made to tighten these regulations, which led to the publication of new regulations in 2017, which, as far as IVD's are concerned, will enter into force in 2022. Despite the fact that a directive is less non-committal than it sounds, it was decided to transform the new regulations into a European regulation. Specifically regulation (EU) 2017/746 on in vitro diagnostic medical devices, or IVDR. A term that will no doubt be familiar to you.

Contrary to directives, regulations work immediately, they do not have to be converted to national regulations first. Citizens and companies can derive rights directly from it, but at the same time obligations are also directly binding. From (as it seems now) 26 May 2022, the old IVDD, and the Dutch Medical Devices Act based on it, will no longer apply and we are all bound by the IVDR.

What will change?

Are you still with me? Nice! The lawyer in me is very proud of you.

Now to discuss what will actually change due to the new IVDR. First of all, the new regulations will provide more and stricter guarantees for the quality of IVD's. Previously, manufacturers could largely indicate themselves whether the European rules had been properly followed by placing a CE mark. For most products this is no longer possible under the IVDR, manufacturers must demonstrate to an independent third party (Notified Bodies) that the correct rules have been applied in the correct manner. A process that diagnotix is already in the middle of now, because all products must be certified before May 26, 2022.

In addition, manufacturers must perform more active Post Market Surveillance activities. This means that they will periodically contact you as a customer to review the safety and clinical performance of the products.

What does that mean for you?

This will cost you some time, but it will also pay off. There will be more guarantees for the clinical substantiation of products and the safety, this means certainly for in-vivo but also for in-vitro devices better results and less burden on the patient.

But what if you, as a hospital laboratory, have developed a method by yourself and produce it in-house. Does this qualify you as a manufacturer within the meaning of the IVDR, and do the higher quality requirements also apply to you? The legal answer to this is “it depends”, which of course is of no use to you. Below I will explain this:

The IVDR contains a number of requirements that every manufacturer must meet, including healthcare institutions that make their own products. These can be found in Annex I of the IVDR (general safety and performance requirements). This appendix alone consists of twelve pages and three separate chapters, and I will not go into substance for now. After all, you have already survived the technical-legal part.

However, under certain conditions, the rest of the IVDR does not apply to you as a producing healthcare institution. I do mention these conditions, because you can deduce from them whether this affects you. Please note that you must meet all nine conditions. As is customary by law, I shall use small print:

An important (if not the most important) condition for you, condition d), is that there should be no equivalent device available on the market. If it does, you must justify why this medical device does not meet your patient's specific needs, while your own device does. Whatever the thought behind this provision may have been, this will result in a significant limitation for you if your method is not (anymore) unique.

Because the regulation has not yet entered into force, it is not yet clear when there is sufficient justification for the specific need of the patients. It goes without saying that what is meant is the situation in which the own device works demonstrably better. It is less certain when financial interests come into play. When the own remedy costs considerably less than a commercially available remedy, it can be argued that the savings flow back to acute patient care. It is difficult to determine at the moment where the boundaries lie in that gray area.

In any case, it is not explicitly prohibited for you as a healthcare institution under the new regulations to develop or continue to use your own method. Due to the aforementioned condition, however, it can be stated that the requirements for you as a hospital laboratory are more stringent than for a commercial manufacturer. Apparently, you are no longer supposed to continue to perform this task. The risk that this arises is that your years of accumulated knowledge and experience is in danger of being lost.

Diagnotix

At Diagnotix we want to work with you on tailor-made solutions. First of all, this means of course a clinical chemical that does what you expect it to do, but given the changing regulations it doesn't stop there. What we want to offer you is a total solution. This may mean that we want to run one of our products to your full satisfaction in your working environment. But this can also mean converting an existing method, your own method, to one that is fully in line with IVDR regulations and is CE certified.

We are able to design your own trusted method in such a way that it meets all new requirements, and you can continue to work on a trusted footing. Or we work together on a new method that meets your exact requirements. Consider, for example, pharmacological calibrators where you are not tied to certain predetermined panels, but with only the components you need.

In this way we can use our knowledge and experience to preserve your knowledge and experience. We have both the clinical-chemical knowledge and the legal support to make your methods compliant with regulations. By entering into a partnership, we can facilitate and store your knowledge, and together we continue to develop the method to bring it into line and to keep it in line with all applicable regulations.