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REGULATORY COMPLIANCE

Following European and national regulations

Merivaara products are CE-marked and comply with governmental regulations. Products are designed to meet requirements of national legislation, the EU directive for medical device (93/42/EEC), and standards that have been harmonised based on these directives.

Class I medical device

The products of Merivaara are classified as Class I medical device, non-sterile and without measuring function, in accordance with the EU directive (93/42/EEC), Annex IX. Based on Annex VII of the same directive, the manufacturer is responsible for the quality assurance and verifies the conformity procedure of the products. As a result of this, Merivaara products are granted a Declaration of Conformity.

Products are registered by Finnish authorities

Merivaara products have been registered with Valvira, the Finnish National Supervisory Authority for Welfare and Health. On demand, Valvira grants Free Sales Certificates for the export of Merivaara products.

Certificates

ISO9001 and ISO13485 Management System Standard, certified by DNV

ISO14001 Management System Standard, certified by DNV

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