Theme Harmonised standard, conformity assessment
Target Audience Manufacturers, Subcontractors, Notified Bodies
Products concerned MD and IVDMD
Documents mentioned MDR (EU) 2017/745

IVDR (EU) 2017/746

Directive 90/385/EEC

Directive 93/42/EEC

Directive 98/79/EC

Regulation (EU) No 1025/2012


This 18-page document specifies how the principles of the New Approach and the New Legislative Framework apply specifically to the MD and IVD sector. It recalls the content, the procedures for obtaining and the use of harmonized European standards. It describes the relationship between regulators and standardization bodies at EU and international level.

All the comments are supported by a comprehensive bibliography on the subject.

To be particularly noted:

  • The voluntary nature of the use of standards (except for symbols),
  • The details given on the consideration of the state of the art, which is not a legally defined concept,
  • What the manufacturer must do to demonstrate compliance with regulatory requirements in the absence of a harmonized European standard.