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 six 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 (MDD) (93/42/EEC). In early 2023, an amendment to the EU MDR transitional timing was approved by the European Parliament, this came into force on 20 March 2023.
This extension allows for all MDD certificates that were valid on 26 May 2021 (and have not been withdrawn) to be extended as follows (providing certain conditions are met):Class III Devices and
- Class IIB Implantable: 31 December 2027
- All others (including IIB Implantable well-establish-technologies): 31 December 2028
- Devices that did not require a certificate under MDD, but does under EU MDR (e.g. Class IR, Class I Software): 31 December 2028
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 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.