New medical device regulations: The view from Europe

New medical device regulations: The view from Europe
by Sheila Galan
Managing Editor, Regulatory Intelligence (Medical Devices), Clarivate Analytics
Life Sciences Connect

The increased globalization of the medical device landscape was a recurring theme as the industry gathered in Philadelphia for the MedTech Conference this fall. Sessions looked at recent regulatory and business developments in several key markets including Brazil, China, India and the U.S. Here is a look at one important panel discussion that took place which featured updates and advice from Europe:

In relation to the European Union, the new regulations for medical devices and in vitro diagnostics (IVDs) were published and adopted in May 2017 and are currently being implemented. Major concerns of the current transition period are not only that there is a huge affectation of the different phases of the CE Mark process, including data requirements and conformity assessment procedures, required inspections or post-market surveillance, but also that “grandfathering” devices will not be accepted and any important steps for their implementation have to be finalized, such as the European Database on Medical Devices (EUDAMED) or the Notified Bodies accreditation.

It will also be a lengthy and challenging transition for Notified Bodies to get ready, panel speakers noted. Furthermore, it is also being questioned if Notified Bodies will be proficient and available to conduct all product reviews prior to May 2020 and May 2022 (for medical devices and IVDs respectively), given that only around half of the active organizations have applied for redesignation. It is more than crucial for patients and healthcare professionals, as well as the medical technology industry, that these issues and many others are sorted out in a timely manner.

 

It is more than crucial for patients and healthcare professionals, as well as the medical technology industry, that these issues and many others are sorted out in a timely manner.”

 

Almut M. Frohlich, legal advisor-medical device safety at the German Federal Ministry of Health, relieved a bit of the tension felt within the audience by pointing out that this new regulatory framework provides the industry with the opportunity to bring devices compliant with the new regulations to market.

Nevertheless, some already CE Marked devices may be commercialized under specific conditions for the grace period as disclosed in the new regulations – even in this case Class I devices not requiring Notified

Body assessment – and new or modified products are exempt and cannot profit via this clause.

John Wilkinson, director of devices, medicines and healthcare products at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), agreed that there is more specificity and guidance needed; however, he advised not to expect any major changes. He pointed out that the regulations were already published covering as much detail as possible in every requirement, and there is a need for practical solutions within the time frame.

EUDAMED may not be ready by the established deadlines, and acts and guidance documents are still being developed and will be published soon, he added. However, the clock keeps ticking as companies strive to get ready for the new regulations; slowing down needs and improvements required will not help with the upcoming deadlines to be faced.

 

… the clock keeps ticking as companies strive to get ready for the new regulations; slowing down needs and improvements required will not help with the upcoming deadlines to be faced.”

 

There was a general warning among the speakers to begin implementing the new regulations without delay. Additionally, device developers were advised to conduct gap assessments and risk analysis, portfolio rationalization if needed, focus on products and processes, and look for resources and consulting groups, in order to make sure that a plan is quickly put in place.

The author’s complete report from the conference in Cortellis Regulatory Intelligence for Medical Devices and IVDs is available here. It includes updates on U.S. FDA regulatory practices, UK actions in the face of BREXIT, updates from the International Medical Device Regulators Forum, as well as expert commentary on regulatory changes and other developments in Brazil, China and India.

 

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