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published on 28 February 2020 | reading time approx. 2,5 minutes
by Dr. Jelena Lysovienė
Manufacturers, authorised representatives, importers and distributors are actively preparing for the most recent EU Regulation on Medical Devices (MDR) 2017/745, coming into force on 26 May 2020.
The new regulation will help the EU medical devices industry to maintain and further expand its leadership and strengthen an important role on the global scale, by making it more competitive and more solid in a complex global environment.
Problems with interpretation of the existing rules as well as serious incidents (e.g. with breast implants and metal hips) highlighted the weaknesses of the current legal environment and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Thus, the changes and new requirements were long-awaited.
Among others one of the most important change coming into force is a simplified administrative procedure. Under the new MDR, registration of devices and operators will have to be performed only once. The registration will be fully valid in all EU member states. This is a significant change compared to current situation where in many cases manufacturers were required to register their products in each member state prior placing products on the respective market.
The MDR changes the classification of medical devices. Thus, depending on the risk of respective medical device it will be regarded differently. For instance, products using software for monitoring purposes being implanted in the body has been transferred to a higher-risk class (from Class I to Class III). Accordingly after the change, the registration would now require conformity assessment by a notified body. Moreover, some products are assigned to the category of medical devices that were never a part of any medical device legal framework.
Due to reclassification occurred, many medical devices will require changes to their existing clinical evaluation reports. The latter will directly affect manufacturers by increasing operational costs. Therefore, it is essential to manufacturers to get to know the changes in classification and to study the impact on their product portfolio.
Unlike MDD (Council Directive 93/42/EEC concerning Medical Devices), where device manufacturers were entitled to use clinical data of an equivalent device for their device registration, the MDR limited these options in particular for higher risk devices. The changes not only will require more financial and time efforts, but also will significantly burden the device manufacturers.
Moreover, medical devices placed on the market prior the MDR and excluded from the reclassification, will still require the reassessment of clinical data.
Strict requirements are also being applied on Notified Bodies (NBs). Notified Bodies will be audited jointly by the local Competent Authority, representatives of the European Commission and another member state Competent Authority. They are required to demonstrate increased technical expertise in their scope of designation, as well as improved quality management systems. Instead of 58 existing notified bodies, only 35-40 will be designated under new MDR and only 11 under IVDR (in-vitro Devices Regulation).
The reason of such low amount of notified bodies, which have submitted the application for designation are its requirements – organisational and general requirements, quality management requirements (competence), resource requirements (in-house experts instead of contracted ones), financial liability, process requirements and others.
The companies are heavily dependent on NBs for auditing and product certification. since all devices will require new certification from a NB, and only newly designated NBs will be entitled to certify a device Whereas there are huge amount of new registrations and re-registrations of old devices the insufficient number of designated NBs will add the risk of many devices being non-registered or non-compliant according to new regulations. The latter along with direct negative impact for the product availability in the market might significantly increase the risk for the patients’ life (due to non-availability). Moreover, such changes might also cause enormous financial losses for the manufacturers.
The new MDR establishes a more comprehensive EU database. A large number of information will become publicly available.
A completely new feature of the MDR is the system of Unique Device Identifiers (UDIs). The system will allow all stakeholders to access basic information on devices through the European Database on Medical Devices (EUDAMED). UDI number must appear on the medical device label, its packaging and, in some cases, the device itself.
EUDAMED will be used by manufacturers not only to report incidents but also as a platform for EU/EEA authorities to cooperate and exchange information.
Achieving compliance with labelling requirements of the MDR will naturally create challenges for medical device companies. Comparing to former MDD requirements, there are several changes, worth discussing.
Firstly, MDR requires beside other information which was provided on labels according to MDD, to provide an UDI carrier, an indication that the device is a medical device, the intended purpose of it, all warnings relating to a device. Previously, the latter was included in the IFU.
Although MDR will not be fully enter into until 2022, the birth of EUDAMED in 2020 means companies could not be prevented from registering or re-registering products. Should companies fail to comply with the requirements, the medical devices will be excluded from the EU market.
According to our experience it is essential to anticipate company’s strategy and the main goals during products registration and its marketing. This requires a clear understanding of future requirements and their implementation.
Usually, companies are lack of necessary practical knowledge to clarify all requirements. This may result in delays of registration processes and their higher costs. Therefore, to ensure all processes go smoothly, it is the best way to forward such duties to professionals. With their help, new legislation coming into force and changes in requirements would not have negative impact on products registration, their proper marketing and maintenance.
Eglė Pinaitė
Associate Partner
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