Certification of medical devices

We deliver international CB certificates and EC-certificates for Europe for your medical devices.

We cover your compliance needs for product requirements (IEC 60601 series) as well as Quality Management System requirements (ISO 13485).

We are accredited according to ISO/IEC 17065 and ISO/IEC 17025.

 

Product certification

Nemko provides international CB certificates for medical devices.

Medical device certification for Europe

  • Medical Device Directive, Class I-m (measuring), I-s (sterile), IIa, IIb, III
  • EC Declaration of Conformity; compiling of test reports and required documentation for the technical file (Annex VII)
  • EC Type Examination Certificate (Annex III)
  • Full Quality Assurance with reference to EN ISO 13485 (Annex II)
  • Production Quality Assurance with reference to EN/ISO 13485  (Annex V)
  • Product Quality Assurance with reference to Annex VI
  • EC Verification Annex IV