Essentials of European Medical Device Regulatory Affairs

Format of D of C

MDD

MDR Annex 4 Item Description

Product Product Product

1

CompanyName registered trade nameor registered trademark if already issued, SRNas referred to inArticle 31of the  manufacturer EUAR, if applicable EUARaddress  (registered place  of  business) EUAR contact location  A statement that theEUdeclaration of conformity is  issuedunder the sole responsibility of themanufacturer Product  Name trade  name product  code catalogue  number  or  other  unambiguous  reference   allowing  identification and  traceability  photograph,  where appropriate intended purpose orbyRef toBasicUDI‐DI referred to in point3 TheBasicUDI‐DIas referred to inPart CofAnnexVI

2

3 4

5 6

Risk classof thedevice  AnnexVIII

A statement declare conformitywithMDRandany   other  relevant  Union  legislation 

7 8

anyCSused in conformity 

NBName NB identification  number  of  the  notified  body a  description  of  the  conformity assessment procedure  performed  identification of the certificate or certificates issued

89

Affix the CE mark and place on the EC market

• Certificate scope is for a product family, eg blood collection needles • Declaration of conformity is for a specific model with identified characteristics, technology, intended use, primary materials etc. • CE mark should be accompanied by the NB number (where applicable) (check NB rules on their logo) • MDD Refer to Annex XII and Article 17 for specific requirements • MDR Annexes 4, 5, 12, and 13