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.
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.
|EU Declarations of Conformity||Product Lists|
|TF-CHATT-012-2_Electrodes Declaration of Conformity_Rev F.pdf||TF-CHATT-012-Master-Data_RevB_CS.pdf|
|TF-DJO-009-A-2 _Specialty Orthopedic Products and Accessories DOC_Rev_F.pdf||DJO-009-A-Master-Data_RevB_CS.pdf|
|TF-DJO-009-B-2 _Specialty Orthopedic Products and Accessories DOC_Rev_F.pdf||DJO-009-B-Master-Data_RevB_CS.pdf|
|TF-DJO-010-2 Rigid-Bracing-wo Measuring DoC Rev M.pdf||TTF-DJO-010-Master-Data_RevB-CS.pdf|
|TF-DJO-011-A Softgoods Upper Extermities DoC Rev P.pdf||TF-DJO-011-A-Master-Data_RevB-CS.pdf|
|TF-DJO-011-B-2_Rev W DoC.pdf||TF-DJO-011-B-Master-Data_RevB-CS.pdf|
|TF-DJO-011-C-2_Softgoods Head and Body Declaration of Conformity_ Rev_J.pdf||TF-DJO-011-C-Master-Data_RevC_CS.pdf|
|TF-DJO-012_Lead Wires Declaration of Conformity_Rev C.pdf||TF-DJO-012-Master-Data_RevB-CS.pdf|
|TF-DRC-001-2 Rev G Dr. Comfort Shoes DoC.pdf||TF-DRC-001-Master-Data_RevB-CS.pdf|
|TF-DRC-002-2- Dr. Comfort Inserts – DoC – Rev D.pdf||DRC-002-Master-Data_RevB-CS.pdf|
|TF-EXOS-001-2 Rev C – EXOS Upper Extremities Declaration of Conformity.pdf||TF-EXOS-001-Master-Data_RevB_CS.pd|
|TF-EXOS-002-2 EXOS Back Brace Products DoC Rev C.pdf||TF-EXOS-002-Master-Data_RevB-CS.pdf|
|TF-CHATT-004-C1_Rev A_Accessories for Ultrasound and Electrotherapy Class I DoC.pdf||TF-CHATT-004-C1-Master-Data_RevB-CS.pdf|
|TF-CHATT-008-C1_Rev A_Traction and Decompression Therapy Systems_DoC_.pdf||TF-CHATT-008-C1-Master-Data_RevB-CS.pdf|
|TF-CHATT-015-C1_Intelect Neo Declaration of Conformity_Rev A.pdf||TF-CHATT-015-C1-Master-Data_RevB-CS.pdf|
|TF-CHATT-017-C1_VitalStim Plus Electrotherapy System Class I DOC_ReV A.pdf||TF-CHATT-017-C1-Master-Data_RevB-CS.pdf|
|TF-CHATT-018-C1 Rev A Chattanooga Primera DOC-Class I_REV A.pdf||TF-CHATT-018-C1-Master-Data_RevB-CS.pdf|
|TF-DJO-002-C1_Rev A_Intermittent Pneumatic Compression Accessories DoC.pdf||TF-DJO-002-C1-Master-Data_RevB-CS.pdf|
|TF-DJO-006-C1_Cold Therapy DOC Class I_Rev A.pdf||TF-DJO-006-C1-Master-Data_RevB-CS.pdf|
|TF-FRA-007-C1_ Intelect Neo Clinical Therapy System Accessories DoC_Rev A.pd||TF-FRA-007-C1-Master-Data_ RevB-CS.pdf|
|TF-FRA-009-C1-2_ ACCESSORIES FOR ELECTROTHERAPY DEVICES DOC_Rev A.pdf||TF-FRA-009-C1-Master-Data_RevB-CS.pdf|
|TF-FRA-012-2 HPL System DOC Class I Accessories Rev A.pdf||TF-FRA-012-C1-Master-Data_RevB-CS.pdf|
|TF-FRA-014-C1 Rev A_Declaration of Conformity Intelect Mobile 2 Accessories_REV A.pdf||TF-FRA-014-C1-Master-Data_RevB-CS.pdf|
|TF-FRA-015-C1_ Intelect Radial Pressure Wave 2 - Accessories-Class I_Declaration of Conformity_Rev A.pdf||TF-FRA-015-C1-Master-Data_RevB-CS.pdf|
|TF-FRA-016-C1 Rev A_Declaration of Conformity Cefar Stimulator Accessories.pdf||TF-FRA-016-C1-Master-Data_RevB-CS.pdf|