Quality Document 7

Product Name

EAN/GTIN

Completed by (Name)

Date

Contact information (E-mail)

Responsible manufacturer

Is the manufacturer located outside EU?

YES

NO

Authorized representative within EU according to article 11, (EU) 2017/745 and 2017/746 (only if the manufacturer is located outside EU)

Importer to EU (only if the manufacturer is located outside EU)

Responsible person for the regulation (article 15, EU 2017/745 and 2017/746)

Certified quality system of manufacturer (ISO 13485)

Classification of device

Ingredient declaration

Attach clear Artwork where all the marking is visible (not a product picture on the front only

Attach Declaration of conformity

Attach certificate by Notified Body (EC-certificate), if applicable

Does your article or product package contain substances of very high concern from the Candidate List (SVHCs) in a concentration above 0,1% w/w (REACH article 33)?

YES

NO

• List the substances

• If relevant, attach information to allow safe use of the article

• Attach the SCIP number received from the submission of information to the SCIP database of European Chemical Agency (ECHA.)

• If any substance is listed in annex XIV in REACH, attach the authorization

Summary over study/literature – Reference for the effect and claim

Does the product fulfill every demand in regulation (EU) 2017/745 or (EU) 2017/746?

YES

NO

Has the product been assigned an UDI by the manufacturer?

YES

NO

Quality Document 7

Quality Documentation - Medical devices