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Medical Device Directives

In order to bring medical devices to the European (EU) market, manufacturers must earn a CE Mark to confirm compliance with the Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC; or in the case of in vitro diagnostic medical devices, the In Vitro Diagnostics Directive (IVDD) 98/79/EC.

These CE marking Directives cover active medical electrical equipment, non-active medical devices, and in vitro diagnostic medical devices; all of which are classified according to the potential risks associated with the device. Most device classifications require both accredited testing and Notified Body services in order to gain the necessary market approvals.

Eurofins Medical Device Testing operates as a Notified Body authorised to issue EC certifications in accordance with the appropriate CE marking Directive; MDD 93/42/EEC or IVDD 98/79/EC:

  • Class II active medical electrical equipment and non-active medical devices
  • Class III medical devices classified as containing a medical substance and/or use tissue of animal origin
  • In vitro diagnostic medical devices, IVDD Annex II devices and devices for self-testing

Choose Eurofins Medical Device Testing to obtain:

✔ EC Type Examination certificates (MDD, Annex III)
✔ EC Verification certificates (MDD, Annex IV)
✔ EC Declaration of Conformity – Production quality assurance (MDD, Annex V)
✔ EC Declaration of Conformity – Product quality assurance (MDD, Annex VI)
✔ EC Declaration of Conformity – Full quality assurance system (Annex II)
✔ EC Declaration of Conformity – Design examination (IVDD, Annex III)
✔ EC Declaration of Conformity – Full quality assurance system (IVDD, Annex IV)

Notified Bodies:

Eurofins Medical Device testing has three designated notified bodies n.0477, n.0537 and n.0681 for CE certification in accordance to 93/42/EEC Directive, and one under 98/79/EC for in-vitro diagnostic medical devices directive.

Our testing and notified body services are supplied through our worldwide network of Eurofins Electrical & Electronic (E&E) laboratories, including tests on non-active medical devices.