Interview on MDR with SIGNUS Head of Quality
The European Medical Device Regulation - MDR for short - has been in force in the EU since May 26, 2021. What does this mean for you and for us? We shed light on it together with our Head of Quality Holger Noß in a personal interview.
Hello Holger!
Since May 2021, the new MDR has come into force in Europe. Can you explain what this means for the medical device industry in Europe?
The MDR is a new European regulation that governs the handling and approval for medical devices. Since it is a European regulation, it will come into force immediately after publication in 2017 and does not have to be implemented in state law - in our case, German law.
The regulation replaces the European Directive 93/42 EEC.
After a transition period, all medical devices must be approved according to this new regulation.
So this means that the MDR is not new at all, but has been legally binding since 2017?
Correct. Because the changes made by the MDR are so large and far-reaching, a 3-year transition period was set. Due to the corona pandemic, this was in turn extended by one year.
Why then is there so much discussion around this MDR, when in total 4 years were available to adapt to the change in the law?
The MDR places product approval and the necessary documentation on a new basis.
All the experience that has been gained up to now cannot be taken over.
This applies not only to medical device manufacturers, but also to notified bodies and distributors.
And what then makes the changeover so complicated that 4 years is not enough?
This is where we now need more background information. I will focus on SIGNUS.
A new risk class Ir for reusable surgical instruments has been introduced: Due to changes in classification rules, some instruments fall through the cracks and go from a Class I product to a Class IIa product. Accordingly, greater involvement of a Notified Body is required.
The scope of clinical evaluation has increased massively and must also be carried out for existing products, some of which have been on the market for decades.
In general, it can be said that the scope of documentation has more than doubled and the respective level of detail has also increased by a multiple.
The changes sound complex, but they should be relatively easy to implement - is what some people must be thinking?
Unfortunately, no. A small example of this is the Notified Bodies.
All Notified Bodies must submit a new application for accreditation and must fulfil stricter conditions in order to be able to continue their activity of testing and awarding the CE mark.
As a result, there are currently only 23 accredited bodies for approval in Europe. Previously there were over 50 notified bodies and 10-15 years ago there were even over 80.
The Notified Bodies have had to reinforce themselves with more personnel in order to be able to meet the specific requirements for testing. Unfortunately, the same specialists are also needed in industry and government regulatory agencies.
As a result, the same number of medical device manufacturers are no longer distributed among 80 notified bodies, but among 23, which obviously delays traditional processes, such as review times, etc.
Do you have another example that shows how complex the topic is?
Yes, for example, direct marking by means of a UDI code (data matrix).
This has already had to be implemented on the packaging for implants this year. In about 2 years, direct marking on non-sterile implants must be loss-proof.
To achieve this, the basic principles must first be developed, tested and validated in production. Since the medical device manufacturers must provide proof of how often the product can be reprocessed.
These developments and tests are underway.
Surely these are technical problems that can be dealt with as part of product development.
True, but unfortunately the transition period for approved medical devices ends in 2024.
This means that by then the development must have been completed, the evidence provided and reviewed by a Notified Body.
The problem here is that a technical standard, the so-called harmonized standards, which serve as the basis for an evaluation procedure (CE approval), will not be available until 2024. This means that companies are forced to make advance payments, with the risk that the notified body will not certify the product or that changes will have to be made to the standard as a result of amendments.
In addition, the associated data must be uploaded electronically to the European database EUDAMED, to ensure full transparency for the public and surveillance authorities.
Unfortunately, EUDAMED will not be completed until 2023, so there are still some questions to be answered, for example, all medical devices used in Europe should be stored in EUDAMED within half a year - this is not feasible in terms of time.
Does this mean that the regulatory basis for implementing the MDR is not in place at all?
Yes, there are many details missing that make it difficult to implement the requirements of the MDR. Practical aids for implementation are missing.
But there are the MDCG guidance documents that are being developed and made available.
Exactly, these are being developed. As a consequence, the ZLG (Central Office of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices) in Germany has already declared that the Guidance Documents are mandatory for Germany.
This in turn means that if a manufacturer applies for a declaration of conformity and a new Guidance Document is published in parallel with the submission, the Notified Body is obliged to apply it, which can lead to deviations that force the manufacturer into a second round. This prolongs the process of approval and costs the company much more money.
How is SIGNUS addressing these issues?
We are working intensively to raise the product files to the level of the MDR and have already submitted the first file. The QM system has already been successfully audited in January 2021 based on the new MDR. Without the QM audit there is no product certificate and vice versa - so this important milestone has been reached.
Despite all the challenges and stumbling stones, we at SIGNUS are positive that together we will also master the MDR.
