Gain market access in Europe with CE marking approval

Gain market access in Europe

CE marking certification

A medical device can only be sold in Europe with a CE mark. By placing the CE mark on a product, the manufacturer declares that it complies with all applicable European Directives and Regulations.

As a full-scope Notified Body for medical devices and in-vitro diagnostic medical devices, BSI The Netherlands (2797) issues CE certificates for MDR and IVDR devices, when required by the legislation.

Class I medical devices that are non-sterile, non-reusable or with no measuring function, do not require a certificate from a Notified Body. The same applies for Class A non-sterile IVDs.

European regulatory framework

In Europe, medical devices and IVDs are regulated respectively by:

The MDR replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). The IVDR replaces the IVD Directive (98/79/EC).

It is up to manufacturer to ensure that the product complies with the essential/General Safety and Performance requirements of the relevant EU legislation. Full compliance of a product to harmonised standards gives to the product the “presumption of conformity” with the relevant requirements. The use of harmonised standards remains voluntary as manufacturers may decide to choose other ways to fulfil the requirements.

For more information visit our MDR and IVDR dedicated webpages. The European Commission has a dedicated section to the Regulations.