For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made the text of the Medical Devices Directives seem obsolete much earlier than anticipated. As a result, the European Commission authorized the development of a new set of industry requirements known as the Medical Devices Regulation (MDR) slated to replace the MDD in 2020.
Compared to the MDD, the EU MDR promotes a shift from the pre-approval stage (i.e. the path to CE Marking) to a life-cycle approach. This approach is similar to the life-cycle view advocated by the FDA here in the US and advanced by many international standards. Greater emphasis will be placed on clinical data and the Clinical Evaluation. Equivalence, currently used to justify referencing to studies done with other devices, will be more rigorously interpreted making this a far more challenging way to demonstrate clinical safety or performance for lower risk medical devices.
For implantable medical devices and Class III devices, clinical investigations will be expected since equivalence will generally no longer be an acceptable approach, although some exceptions can be made. This requirement will not be applicable for devices that have been lawfully placed on the market in accordance with the AIMD and MDD where their demonstration of conformance is based on sufficient clinical data and applicable Common Specifications (CS).
One of the many significant changes in the EU MDR is the number of definitions. Previously, the MDD contained only 14 definitions – the EU MDR has over 70. The definition of medical devices is extended to include products for cleaning, disinfection, or sterilization. Previously, products used for cleaning, disinfection, or sterilization were accessories to medical devices and hence accessories to cleaning, disinfection, or sterilization products were not within the remit of the directive. If these products now become medical devices, their accessories will be covered by the Regulation. As these devices may rely on chemical reactions that could be considered pharmacological, immunological or metabolic, it is obvious they are listed after the exception made for the regular medical devices regarding this mode of action. Less clear is why this is also done with medical devices intended to control or support conception. It appears they may rely on a pharmacological, immunological or metabolic action.
The Regulation will also apply to a specific group of devices that do not meet the exact
definition of medical devices but may have a ‘medical character.’ A medical device incorporating an in vitro diagnostic medical device (IVD) will be governed by the MDR, although the requirements of the EU IVDR will apply to the IVD part of the device. This would imply that a Class I medical device incorporating a Class B, C, or D IVD requires notified body involvement.
While this fundamentally new set of regulations affects only the European market, it is a seismic regulatory change and will significantly affect any US company looking to start – or continue – doing business in the EU. Unfortunately, the European market is not governed by a single watchdog agency like the FDA here in the United States. Instead, regulations are administered by private companies – in the past, there have been up to 100 regulatory firms, known as Notified Bodies (NBs) tasked with evaluating and approving devices for sale into the European market.
Under this new law, all medical devices have to be re-evaluated (even if you were on the market for 20 years) and there are currently only seven NBs who have been qualified to review and approve medical devices. Ten additional NBs are still pending EU MDR designation.
Currently, approval timelines are over a year. That means if you submit your technical data now, it may take until November 2020 for you to hear back, that’s only if there are no questions.
All of this EU regulatory revision should serve as a cautionary tale to any US medical device manufacturer currently in, or considering entering, the European market. The clock is ticking on device approval requirements and any company looking to do business in Europe needs to be actively addressing the challenges the MDR will present.
For medical device consulting, including assistance with navigation through the European market, contact the regulatory experts here at MEDIcept.