Class IIa/b/Non-General/Class B, Class C or Class D IVD Self Certification CE Marking

Complete project to achieve CE/UKCA marking and registration of a Class IIa, Class IIb or Non-General IVD (Class B or Class C) medical device (SaMD, physical and IVD – combined included) under the either of the following legislation:

  • UK Medical Devices Regulation (2002) as it exists from 1st January 2021.
  • Medical Devices Directive 93/42/EEC.
  • In Vitro Diagnostic Medical Devices Directive 98/79/EC.
  • Active Implantable Medical Devices Directive 90/385/EEC.
  • EU Medical Devices Regulation 2017/745.
  • EU In Vitro Diagnostic Medical Devices Regulation 2017/746.

This project must run alongside or follow on after a QMS build and ISO 13485 certification project.

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