In May of 2021 the European Union’s new Medical Device Regulation (MDR) came into effect, replacing the prior Medical Device Directive (MDD). The aim of the new regulation is to address some inherent weaknesses in the old directive, and to support the swift evolution of science and technology in the field of medical devices.
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We want to assure you, we are committed to meeting all regulatory requirements in the markets where our products are sold. We understand how crucial this is to our customers and distributor partners, and we want you to know that when you receive products from DJO you can be confident that they are safe, reliable, and meet all applicable requirements.
DJO’s Class I products that are placed and made available for sale in the European Union are compliant to the MDR standards as of May 2021. As allowed by the MDR, products that were manufactured under the MDD and already on the market in the EU will continue to be distributed (until their expiration date, if applicable). Class IIa, IIb and Class III products that were certified by our notified body prior to the May 2021 application of the MDR will continue to be manufactured and distributed under their MDD certification as allowed by the MDR. We are committed to ensuring they are compliant before the MDRs mandated May 2024 compliance date. All DJO products distributed within the European Community are imported under appropriate importer oversight, wherever those products are received initially in the EU.
Among other things, this website contains access to the DJO IFUs and declarations of conformance related to our products. Please feel free to access this site for your documentation needs, and as always continue to reach out to your local DJO sales representative as well with any requests.
Distributors and Importers who will provide localized translations of DJO labeling information (IFUs, boxes, packaging labels) are required to meet specified requirements. Submit the translations and completed Form 1000.1134 to your local sales representative for review and approval. Sales representatives shall then submit the approved form to SupplierQuality@DJOGlobal.com.