Medical Devices Directive (MDD)
The Medical Devices Directive 93/42/EEC (MDD) was taken effect in 1993, and has been revised in 2010. The Medical Device Regulation (MDR) (EU 2017/745) published in May 2017, has replaced the Medical Devices Directive. Read more about the MDR.
The MDD concerned medical devices that are manufactured or traded in the EU. The MDD applied to all general medical devices that do not fall under the EU regulations Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDMD). When devices met all MDD requirements, they received a CE mark.
Kiwa Notified Body for medical devices
Within the Kiwa group, Kiwa Cermet Italia (NB 0476) and Kiwa Belgelenddirme Hizmetleri in Turkey (NB 1984) boast a wide and in-depth experience as Notified Bodies in medical devices certification. Read more