| Theme | Conformity Assessment of the Technical Documentation : sampling |
| Target Audience | Manufacturers, Notified Bodies |
| Products Concerned | Classes IIa and IIb non implantable MD
Classes B and C IVD |
| Regulatory reference | MDR (EU) 2017/745
Article 52(4) et 52(6) Annex IX section 2.3, 3.4 and 3.5 Annexe XI section 10.2 Annex VII 4.5.1, 4.5.2(a) and 4.5.2(b) IVDR (EU) 2017/746 Article 48(7) et 48(9) Annex IX section 2.3 et 3.5 Annex VII 4.5.1, 4.5.2(a) and 4.5.2(b) |
| Documents mentioned | European Nomenclature of Medical Device (EMDN)
MDCG 2018-1 V3 Regulation (EU) 2017/2185
|
This guide defines the sampling criteria for the evaluation of the technical documentation for Class IIa and IIb non implantable MD and Class B and C IVD.