The new EU-MDR has been published on May 5, 2017 and will come into effect on May 26, 2020. This new Regulation is more explicit than the current legislation, which means that the Medical Device sector will need to increase its general level. To help you understand the impact of the new EU-MDR on the Chinese medical device manufacturers, we have asked two of our experts: Minghua Chen and Jan-Paul van Loon, to share their first experiences from a regulatory consultant’s perspective.
Qserve supports medical device manufacturers to achieve market access all over the world for all types of Medical Devices. For example, we help medical device manufacturers to enter the Chinese market and support Chinese manufacturers to access the European market by offering a wide range of dedicated services.
The new European Medical Device Regulation (MDR) has been published on May 5, 2017 and will come into effect on May 26, 2020. This new Regulation is more explicit than the current legislation, which means that the Medical Device sector will need to increase its general level. To help you understand the impact of the new EU-MDR on the Chinese medical device manufacturers, we have asked two of our experts: Minghua Chen and Jan-Paul van Loon, to share their first experiences from a regulatory consultant’s perspective.
Minghua Chen is responsible for planning and executing business development and sales activities, including presenting new solutions and services to customers. She is actively growing the presence of Qserve in China.
Jan-Paul van Loon is very experienced in the whole process starting from the development of a device to its market introduction, including setting up an ISO 13485 quality system, compiling technical files, performing risk-based process validations, submitting international clinical trials and writing clinical evaluations.
Which Chinese medical devices are popular in the European medical device market?
Minghua: There are a lot of wound-dressing products in the European market which are provided by Chinese manufacturers, In addition, there is a trend towards higher-risk products. Several Chinese manufacturers of high-risk products are currently in the process of applying for CE certification, in order to enter the EU market.
What do Notified Bodies do to inform Chinese medical devices manufacturers about the changes in the European MDR?
Minghua: The Chinese offices of the key Notified Bodies present in China provide many trainings for medical device manufacturers to prepare them for the new EU-MDR.
Chinese companies with big business in Europe has started the training and internal gap analysis, whilst others with little opportunities in Europe are now struggling, re-evaluate the return on investment and reset the strategy for the EU market.
Is it interesting for Chinese medical devices manufacturers to access the European market?
Jan-Paul: Yes, Europe is a large potential market for China. Despite the large population in China, at this moment only a minority can afford expensive medical expenses. In contrast, in most European countries, citizens have a good health insurance that will pay for expensive medical treatments.
What are the focal points of the CFDA and the Chinese government?
Minghua: CFDA officers paid a lot of attention to the EU regulation changes and organized the study groups internally. As China is the chair of IMDRF this year, CFDA will focus more on the global regulation harmonization, which of course include the new EU regs.Jan-Paul: What you see now, is that the Chinese government has told the medical device companies that they should focus more on R&D, new developments, higher risk products (more added value). So, the Chinese medical device companies are pushed by their government to focus on these areas.
What are the main challenges for the Chinese manufacturers to access the European market?
Jan-Paul: In general, the level of the Technical Documentation has started to increase during the last years. Documentation which was approved by the Notified Bodies some five years ago is now no longer accepted. The Notified Bodies are asking much more details than they did in the past. For European manufacturers this is already a burden, however, for Chinese manufacturers, which are located further away and for which there might also be a language problem, this presents an even greater challenge.
Specifically, the usability-aspects and the clinical evaluation must have a much more in-depth analysis than before. Notified Bodies ask for a more detailed explanation of why the medical device does what it does (the intended use must be clear), proof of the user understanding how to operate the device, and more clinical data to prove that the device is safe and performs as intended. And all need to be connected through risk management. For example, all warning in the Instructions for Use must be an output of risks mentioned in the risk analysis. This is something which is not yet common practice for Chinese manufacturers.
Could you give us an example of the challenge(s) that these Chinese companies are facing?
Jan-Paul: One type of projects is to assist Chinese companies by performing clinical evaluations. What I noticed is that Chinese manufacturers of high-risk products are struggling with the concept of the risk-benefit ratio of their device and with risk management.
What is your advice?
Jan-Paul: Following the Plan-Do-Check-Act cycle is becoming much more important. As one Chinese client explained to me, it is a Chinese habit that two or more departments work at the same time on different phases of a project to meet the deadline. For example, tests are already performed while the protocol is not yet finalized. Notified Bodies want to see that the plan (protocol) was there first and that the activities were performed according to this plan. Finally, the report must have an analysis of the results and a clear conclusion whether the (test) results are acceptable.
I would also like to mention that: in addition to supporting Chinese manufacturers to access the European market, Qserve can also help international manufacturers enter the Chinese market (market access). How? By offering a wide range of dedicated services, including building regulatory strategy plan, Clinical Affairs, CFDA China Agent, CFDA registration and CRO services. Qserve has a local entity in China (Wholly Foreign-Owned Enterprise). On top of that, all Qserve consultants have had former positions at medical device manufacturers, CRO’s, European Notified Bodies, US FDA or Chinese CFDA.