| 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.