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EC Certification for medical devices and quality assurance systems

SLG is a Notified Body - registered under 0494 - entitled to carry out conformity assessment procedures according to the Medical Device Directive MDD 93/42/EEC for active medical devices.

We are notified for the following scopes:

General active medical devices

  • MD 1102 Respiratory devices, devices for oxygen therapy, inhalation devices
  • MD 1103 Devices for stimulation or inhibition
  • MD 1104 Surgical devices
  • MD 1105 Ophthalmologic devices
  • MD 1106 Dental devices
  • MD 1108 Rehabilitation devices and hearing aids
  • MD 1109 Devices for patient positioning and transport
  • MD 1111 Medical gas supply systems and parts thereof
  • MD 1112 Software

Devices for imaging

  • MD 1201 Imaging devices utilising ionizing radiation
  • MD 1202 Imaging devices utilising non-ionizing radiation

Monitoring devices

  • MD 1301 Monitoring devices of non-vital physiological parameters
  • MD 1302 Monitoring devices of vital physiological parameters

Devices for radiation therapy and thermo therapy

  • MD 1402 Devices utilising non-ionising radiation
  • MD 1403 Devices for hyperthermia

A conformity assessment is among others one condition for CE marking and for the use of the Notified Body's registration number, if required.

We provide the following conformity assessment services according to MDD 93/42/EEC:

  • acc. to annex II (keyword: full quality assurance system) excluding section 4
  • acc. to annex III (keyword: EC type examination)
  • acc. to annex IV (keyword: EC verification)
  • acc. to annex V (keyword: production quality assurance)
  • acc. to annex VI (keyword: product quality assurance)

Please note: SLG Prüf- und Zertifizierungs GmbH prepares project-related quotations based on a specific client request and necessary information provided for the intended project. Quotations for our services usually state end prices which include hourly rates for services provided by SLG's employees. The hourly rates are either stated in the quotation or communicated on request. For maintaining a certification, costs for monitoring measures may arise depending on the certification programme. These costs are disclosed to the client in the quotation for the certification.