Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?
Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA
We are now almost one-third of the way into the 3-year transition period for the EU Medical Devices Regulation (2017/745/EU) (MDR).
The MDR has significant economic impact on manufacturers — not just the cost of implementing the new regulations for new products, but ensuring legacy products meet the new requirements, as there is no grandfathering from the current EU Medical Devices Directive (MDD). The MDR has a big impact on distributors and importers, as well as manufacturers. This means that some distributors/importers (Economic Operators) of CE-marked products may cease their involvement under the MDR. The medical device supply chain is quite complex, often with involvement of multiple distributors, from manufacturers to patients. It is a global issue, as it affects all manufacturers/distributors that sell in to the EU.