Mr Shoukier, there is currently some uncertainty about the implementation of the new Medical Device Regulation MDR. When does it actually take effect?
In summer 2016 the preliminary text was published. The actual entry into force is expected at the beginning of 2017. In a next step, Parliament will have to agree to the text in Brussels. At the last meeting of the Notified Bodies in Brussels, it became clear that there were many objections and resistances by industry and associations, which need to be resolved. It is conceivable that the discussions in Brussels might be delayed and the entry into force will be delayed.
Why do we need a new Medical Device Regulation?
In the past, there have been several incidents of medical products that have frightened the public and led to a negative image of the medical technology sector. This includes, for example, the much-cited PIP scandal (maladjusted breast implants were deliberately used by a manufacturer, which led to some dramatic complications for several thousand patients across Europe). Politicians have responded to these incidents by launching a new medical device regulation. The need for the new regulation is very controversial within the industry, the authorities and notified bodies, because the existing system is considered to be effective, efficient and safe. Not all stakeholders share the view that a new regulation has to be introduced because of a few negative incidents. Even the new MDR cannot eliminate the criminal power of an individual company.
What is the impact of the MDR on manufacturers, patients and the medical profession?
The registration of medical devices will be much more difficult, because the requirements are increasing dramatically. It is estimated that, as a direct consequence, about a third of all medical device manufacturers will disappear from the market as the new requirements cannot be met in practice. A long-term consequence will be that we will have less access to innovation in the future. Many start-ups will give up or fail to register their device in Europe, and latest innovative developments will no longer be available in Europe.
What specific effects does this have on us as possible patients?
Since the supply of innovative products is no longer guaranteed and the price increases, the health care system will be burdened significantly with higher costs. Today, Europe is regarded as an innovation forge in the world. Patients of all over the world come to Europe to be treated with the latest innovative technology. This could change in the future.
Were the previous rules insufficient?
No, our current system is considered to be very safe and effective. The Notified Bodies as well as the manufacturers do a good job on the present regulation. The political discussion alone has created the need of more regulation and requirements.
Give us an example of a new requirement for manufacturers.
For high-risk products and implants, which have been successfully established for decades, new clinical trials have to be carried out by manufacturers. This means enormous costs, which will lead especially to smaller companies in distress. Apart from this, it will be difficult to find enough patients and clinics for these additional studies. There are also ethical aspects that make clinical studies questionable in certain contexts, for example when involving children.
Does the development of the new MDR already have an effect in practice?
Yes. Unannounced audits are carried out by the Notified Bodies. In addition to additional costs, this procedure attends the time period for admission because the resources of the Notified Bodies are thus often overloaded. As a result, a large number of Notified Bodies are giving up their accreditation and many companies are currently without a Notified Body. This means that they are not allowed to sell their products and are endangered in their economic existence.
The interview was conducted by Judith Shoukier.
The book: "The New European Medical Regulation. A comprehensive overview in questions and answers."
The book is an introduction to the complex subject and shows how to work with the new MDR. It will be released in spring 2017 in English.
Daniel Shoukier is an internationally recognized expert on the approval of medical devices and operates as an auditor and consultant for a Swiss Notified Body. He is the Managing Director of Bellingswood Regulatory Consulting and advises medical device manufacturers regarding the registration of their products.
Daniel Shoukier is giving lectures at MEDICA at the stand of the Asia Regulatory & Quality Consultancy for Medical Devices & Drugs (ARQon) in Hall 16, stand 16G58-05: Meet him there at 15 and 16 November from 2.00-3.00 p.m. and 3.00-4.00 p.m.