To Whom it May Concern
NO-xx/xxxx
Date: xx.xx.xxxx

Certificate of Free Sale

The Norwegian Medical Products Agency as competent authority for medical devices hereby declares that the following manufacturer has its registered place of business in Norway:

Eventuell produksjonssted på vegne av norsk produsent

Adresse

Land	– stryk dette avsnittet hvis det ikke er aktuelt.

For	Produsent

Adresse

Adresse

Norway

We have been notified that the following medical devices are sold as CE-marked products:

Product Name	Certificate number
Identisk med navn i Samsvarserklæring og Utstyrsregister	Dersom relevant

The precondition for medical devices to be CE-marked in compliance with directive 90/385/EEC, directive 93/42/EEC or directive 98/79/EEC is to meet the essential requirements for safety. A CE-marked medical device may be marketed within the European Union/European Economic Area without any approval from the Norwegian Medical Products Agency, and may be exported without any restrictions. Regulation (EU) 2017/745 article 120 and Regulation (EU) 2017/746 article 110 allows for certain devices placed on the market under directive 93/42/EEC and 98/79/EEC to still be lawfully placed on the market, assuming certain conditions are met.

This certificate is valid until xx. Month xxxx

Raymond Ludvigsen	Jørgen Bryn

Senior Adviser	Consultant