Mericon Medical Device Approval
Products & Services | Mericon AS
Mericon AS is a Norwegian contract research organization (CRO) that can help in regulatory and marketing work of medical devices.
Although Norway is not a member of the European Union (EU), it is a signatory to the European Economic Area (EEA) agreement and is therefore bound by requirements that harmonize with the rest of Europe.
In particular, Norway’s regulatory system recognizes the provisions of the EU’s 93/42/EECMedical Device Directive, 90/385/EECActive Implantable Medical Device Directive and 98/79/ECIn Vitro Diagnostic Directive.Compliance with such directives entitles the medical device marketed and sold in Norway to bear the European standards CE mark.
However, medical device manufacturers and EU authorized representatives must register products with the Norwegian authorities, all labelling and instructions provided by the manufacturer must be in Norwegian and registration must comply with the requirements of the Norwegian Directorate of Health.
In addition, all marketing materials must meet local expectations for accuracy, fluency of language, accuracy, clarity and readability.
Mericon specializes in registration and marketing support. This includes evaluation and review of documentation prior to submission to the Norwegian Directorate of Health and other health and environmental authorities.
Detailed knowledge of Norwegian and European legislation and guidelines is kept up to date.
Mericon has experience in helping clients generate applications and supporting information as well as evaluate and adapt marketing materials to local expectations.
Mericon’s device authorization services draw on extensive experience in assisting manufacturers and life sciences companies with regulatory affairs management at all levels. Detailed regulatory affairs services include:
- Mediating engagement with The Norwegian Directorate of Health
- Detailed guidance on Norwegian procedures and requirements
- Assisting with submissions of applications
- Assist with submissions of variations to application
- Preparing and updating Norwegian product information
- Ensuring marketing and package information complies with Norwegian law and market expectations
Membership of the international alliance European Drug Regulatory Affairs Consultants (EuDRAcon) provides Mericon with close liaison with regulatory affairs consultancies dealing with drugs, medical devices, cosmetics and food supplements across Europe. EuDRAcon members share a long history of cooperation in various international regulatory projects.