Regulatory compliance

Following directives and regulations

Merivaara products are CE-marked and comply with applicable requirements. Products are designed to meet requirements of the EU directives, regulations and national laws. All Merivaara products are complying to Medical Device Regulation (EU) 2017/745, state-of-the-art and harmonized standards.

Class I medical device

The products of Merivaara are classified as low risk Class I medical device, non-sterile, without measuring function and as not reusable surgical device, in accordance with the EU Regulation 2017/745 Annex VIII.

Products are registered by Finnish authorities

Merivaara products have been registered with Fimea, the Finnish Medicines Agency which is National Competent Authority for medical devices. On demand, Fimea grants Free Sales Certificates for the export of Merivaara products.

Management System Certificates

ISO9001 and ISO13485 Management System Standard, certified by Kiwa Inspecta

ISO14001 Management System Standard, certified by Kiwa Inspecta