Description: authorized representative ce marked medical devices, machinery, ped and ppe, eu authorized representative.
notified body (11) authorized representative (10) eu authorized representative (2) eu notified bodies (2) ce marked medical device (2) ce medical device (2) ce marked machinery. (2)
EU Authorized Representative under the Medical Device Directive 93/42/EEC, IVD Directive98/79/EC and the Machinery Directive 2006/42/EC, Personal Protective Equipment Directive 89/686/EEC, ATEX Directive 2014/34/EC, Pressure Equipment Directive 2014/68/EU.
Medical device manufacturers located outside the European Union are required to have a European Authorized Representative in accordance with Medical Devices Directive 93/42/EC and IVD Directive 98/79/EC.
Frequently asked questions about he role of the Authorized Representative can be found here.