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Smith+Nephew and the European Union Medical Device Regulation

For more than 160 years, Smith+Nephew has been delivering innovative medical technologies and solutions across the globe. We are proud of our heritage and confident of an exciting future.

To continue to support our customers and patients we have to adapt to our changing environment and regulatory framework.

One current, significant regulatory change is the introduction of the European Medical Device Regulation 2017/745 “EU MDR”, which came into force 26 May 2017 and will become directly applicable on 26 May 2021 in all EU Member States.

Smith+Nephew intends to comply fully with this new European Medical Device Regulation.

Smith+Nephew is currently assessing the impact of the new regulation on the business, engaging with Notified Bodies and proceeding to implement changes in line with the new regulation.

Implementation timelines for transition to EU MDR are dependent on provisions laid out within the regulation and the expiry of existing certification under the Medical Device Directive (93/42/EEC). As per the regulation, this will be no later than May 2024.

Smith+Nephew will continue to notify customers of any portfolio updates in the future in the normal manner.

We are addressing the requirements of the EU MDR proactively and with the positive changes that the EU MDR will bring to the European regulatory framework, we look forward to our technology continuing to serve health care professionals and their patients in a better way in the coming years.

View the Smith+Nephew timeline to reach EU MDR compliance (PDF)