Medical Devices

The market for healthcare products is global but the industry is heavily regulated in all important market areas. Regulatory approval methods in the countries with the largest market potential are different, complex, and unfortunately only in few cases mutually recognized.

Products must comply with EU regulations in the European Economic Area, FDA's requirements in the United States, Health Canada's requirements in Canada, JPAL regulations in Japan, TGA requirements in Australia. In addition, many important countries globally have their own regulatory systems for medical devices.

Placing medical devices on the market often requires the mandatory use of a third party (e.g. Notified Body in Europe) in the approval or certification process. Eurofins Electric and Electronics Finland Oy is designated as Notified Body for various conformity assessment procedures.

Our services include

Notified Body services (NB 0537) for conformity assessment (CE marking) of products for the European market

Certification of quality management systems against quality management system standard ISO 13485 on a voluntary basis

Quality management system audits under MDSAP (Medical Device Single Audit Program)

Notified Body scopes of designation

• Regulation (EU) 2017/745 – Medical Devices
• Regulation (EU) 2017/746 – In Vitro Medical Devices
• Directive 93/42/EEC - Medical devices
• Directive 98/79/EC - In vitro diagnostic medical devices

Eurofins Electric and Electronics Finland

Finnish Notified Body since 1995 for both medical devices and IVD medical devices

Audits related to the conformity assessment (CE-marking) of medical devices and to the certification of the quality management system (ISO 13485, ISO 9001) are possible to be combined

We are committed to high quality and independent assessment activities

MDR and IVDR Notified Body

• Declarations of interest of top-level management MDR
• Declarations of interest of top-level management IVDR
• Description of the application procedure by which manufacturers can obtain and maintain the certification
• List of standard fees for the conformity assessment activities
• Information of certificates issued
• Eurofins Electric and Electronics Oy does not have any subsidiaries