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EU/US Regulatory Strategy

When developing a new medical device, whether it is a piece of electronic equipment, a single-use item, sterile or not, an in vitro diagnostic (IVD), or a combination product, all too often, the regulatory strategy is considered unimportant or even ignored until it is too late to make any optimal determination about the first market entry point. It is no longer the case that “Europe is easier than the US“. For many devices now, with the introduction of the European Medical Devices Regulations (MDR, 2017/745 and IVDR, 2017/746), the European system presents greater regulatory hurdles than US Food and Drug Administration (FDA) requirements.

For many reasons, therefore, it is critically important for a timely device launch and future market growth that regulatory options are researched and developed along with the design, verification and validation of the device itself, with all corporate stakeholders working towards the same goal.

Donawa Lifescience can help companies understand the current and forthcoming regulatory environments in Europe and the US, and how they apply to specific devices, taking into consideration their development timescales and the technical documentation and clinical data requirements for each regulatory jurisdiction, together with how these are planned to change in the short and medium term.

As a starting point for a regulatory strategy discussion, Donawa recommends the development of a “regulatory road map’ for each device, laying out the pros and cons of each available option and alternative.

For further information and assistance, please contact us to see how we may be able to assist you.