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 became directly applicable on 26 May 2021 in all EU Member States.

Smith+Nephew is fully complying with this new European Medical Device Regulation and we have been addressing the requirements proactively over the last four years. A focused internal programme team has been working with our Notified Bodies to CE mark devices under the new regulation. We have also remodeled our EU supply chain to ensure that Economic Operator requirements were met by the Date of Application.

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. As such, our customers will receive a mix of MDD and EU MDR CE marked devices up to 26 May 2025.

Most Smith+Nephew CE marked products are being migrated from the existing Medical Device Directive regulation (MDD) to EU MDR. Smith+Nephew is already shipping Class I EU MDR compliant products to the EU region and work continues to bring all Smith+Nephew devices to EU MDR compliance.

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

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)