MDD Medical Device

Medical Devices Directive (Medical Devices Directive, 93/42 / EEC)

All medical devices imported and exported to the European market are subject to the CE mark is mandatory. Because medical devices use items that are used by humans, the emphasis on safety and reliability can make it more difficult and expensive to consume than other certification schemes.

Medical Device Related Guidelines

  • Guidelines for Active Intracorporeal Medical Devices (AIMD) : Active Implantable Medical Directive, 90/385/EEC
  • Medical Device Directive (MDD) : Medical Devices Directive, 93/42/EEC
  • In Vitro Diagnostic Medical Device Directive (IVD) : In Vitro Diagnostic Directive, 98/79/EC