Medical Device Regulation (MDR)
A risk to the Medical Device Industry?
The European Parliament adopted the new EU Medical Devices Regulation (MDR) on 05.04.2017 at second reading. The Medical Devices Ordinance and the Ordinance on In Vitro Diagnostics will now be published in the Official Journal and will enter into force after more than four years of negotiations in July 2017 and replace the existing medical device directives.
The new regulations for medical devices will be applied three years after their publication, the one for in vitro diagnostics five years after their publication.
The entire set of rules covers more than 700 pages and we would like to take this opportunity to provide you with an overview of some of the changes in the Medical Device Regulation that might be relevant to your future strategic direction.
Why are the Medical Device Directive (MDD) and the Active Implantable Medical Devices (AIMD) replaced?
Let us begin with the question of whether the path to a new regulation was necessary at all. Was not everything already regulated? Was something missing? Well, it was regulated already. The question is rather more: What was regulated and from when did it date? Did the regulation still correspond to the current circumstances and necessities?
In Germany, Medical Device Regulation (MDR) replaces Directive 93/42 / EEC on medical devices (MDD) and Directive 90/385 / EEC on active implantable medical devices (AIMD) which both dated from the 1990s.
Thanks to significant progress in research and technology, medical devices as well as in vitro diagnostics have become more mature and innovative over the past 30 years and thus the regulations of the 1990s have not been able to keep pace with the rapid developments in the healthcare sector. Medical product scandals from the recent past have once again made it clear to all of us.
Among other things, the modernization of the legal framework for medical devices has become indispensable.
The Medical Device Regulation (MDR) is now working to ensure that medical devices are safer and can be traded across the EU. It also aims to provide new, innovative products to the patient at an early stage, focused on safety for the patient and distribution standards in Europe.
Is this pure wishful thinking or the future reality? Read the next paragraph, which structural changes the Medical Device Regulation (MDR) will entail.
What is regulated with the Medical Device Regulation (MDR)?
In essence, the Medical Device Regulation (MDR) provides the following:
- Safety of medical devices
For this purpose, an extended mandate is issued to the independent notified bodies, which evaluate the medical devices before they can be placed on the market. In addition, these bodies will are more stringent supervised by the national authorities.
According to the new rules, notified bodies must also meet the same high safety standards throughout the EU.
- Continuous improvement of the products
To this end, more available clinical data on medical devices and a clear description of manufacturers‘ responsibilities for monitoring the quality, performance and safety of the products placed on the market will be provided. This will enable manufacturers to respond more quickly to potential concerns and to continually improve their products based on current data.
- Unique identification number
The product identification number is intended to enable better traceability of the medical devices along the entire supply chain to the end user or patient. With the aid of this identification number, the necessary measures can then be taken quickly, in the case of security problems.
- Central database
The database EUDAMED has so far been exclusively reserved for state institutions. In the future, it will also be made available to manufacturers, notified bodies and the general public and will include comprehensive information on the products available in the European Union. This ensures that all involved parties in the future are able to make decisions in full knowledge of the situation.
These are the key factors which likely include changes in technical documentation, the labeling of medical devices, clinical assessments, the classification of some medical devices, the reprocessing of single-use products and the requirements for products with hazardous substances.
What are the effects of the Medical Device Regulation (MDR)?
We appreciate your understanding that the list above does not claim to be complete. Nevertheless, it already shows clearly which comprehensive changes the medical device manufacturers, depending on the field of activity and the existing evidence situation, expect in the future.
The consequences of this and the necessary strategic changes must, of course, be examined in the individual case.
For the sake of completeness, it should also be mentioned at this point that the Medical Device Regulation (MDR) is already viewed very critically from different perspectives.
The small and medium-sized medical technology companies (Medtech SMEs) are, for example, heavily disadvantaged by the new regulation. Through the introduction of detailed and comprehensive evaluations of Medtech products, a rapid market access for innovative technologies is more likely than blocked and perceived as cost and staff intensive so that this cannot be achieved by SMEs.
Also, a bottleneck is being feared in the areas of certifications and regulatory issues due to lack of skilled personnel. Manufacturers should contact their Notified Body. The active exchange on these topics among the industry associations is recommended.
A special additional procedure („scrutiny method“) will be applied to certain medical devices with a higher risk of application. This method is also regarded as critical, since this would lead to a delay in the launch of the product on the market.
In this procedure, the Notified Body shall draw up a report on the evaluation of clinical evaluation, which is then forwarded by the Commission to an expert panel. The Panel decides whether it will submit its own scientific opinion within 60 days. The opinions expressed in the expert opinion must be taken into account. In case of non-consideration, a comprehensive statement of reasons is required. If no expert opinion is submitted, the certification procedure can be continued.
From the medical device manufacturers point of view, the requirements for clinical trials are viewed critically. The large number of individual requirements of the new Medical Device Regulation (MDR) is expected to lead to a significant increase in planning, preparation, implementation and reporting costs for medical device manufacturers.
In particular due to the continuous clinical evaluation and the periodical reports on the entire life of the product, more studies are required after approval.
Also for this reason, the current study strategy must certainly be viewed critically on the side of medical device manufacturers, re-evaluated and, if necessary, adapted.
When does the Medical Device Regulation (MDR) come into force?
On 04/05/2017, the European Parliament adopted the new EU Medical Device Regulation (MDR) at second reading. The MDR enters into force 20 days after publication in the EU Official Journal.
Six months after entry into force, ie at the end of 2017, the rules on notified bodies apply.
The start of the new MDR regulations will be after a three-year transition period mid-2020. The previous guidelines are valid for a maximum of four years after the beginning of the application for medical products marketed on the basis of „guidelines“.
However, the new regulations on market surveillance, vigilance and registration apply to these „old products“.
As regards the requirements for the clinical evaluation of medical devices, it must be borne in mind that a clinical development plan, including a plan for clinical follow-up, is to be prepared by medical device manufacturers. Existing gaps must be closed by clinical studies or application observations. As part of the technical documentation, the medical device manufacturer also has to write a report on the clinical evaluation.
The approval procedures for clinical trials are standardized throughout the EU.
The time periods are tight and many other points have to be taken into account in order to be placed on the market in a timely and secure manner with innovative and high-quality medical devices. Are you well prepared?
About „use it AG“
As an independent partner, „use it AG“ combines industry-specific know-how and focuses on the disruptive innovation of existing business models, products, technologies and services.
The company is focussing on the digitization of the organizational structure and the development of new solutions in an increasingly challenging digital world, taking into account human performance.
The references include international corporations, major medium-sized companies, important organizations such as cooperatives, associations, societies and institutions of public law.
We are looking forward to answering your questions about this exciting and challenging topic.
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