Gain market access in Europe with CE marking approval

New Medical Devices Regulation and IVD Regulation now published

European market accessOn 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices.

The final texts of the new European Medical Devices Regulation (MDR) and IVD Regulation (IVDR) have now been published in the Official Journal of the European Union. Entry into force will commence on May 26th, marking the start of the transition period for manufacturers selling medical devices into Europe.

The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. The IVDR, which replaces the IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

You can find more information on our dedicated revisions webpages:

MDR Revision

IVDR Revision

Read the final texts here


CE marking approval and 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 their product complies with all applicable European Medical Device Directives. As a full scope Notified Body for medical device CE marking, we can issue device-specific CE certificates and Declarations of Conformity for your Class I sterile or measuring, Class IIa, Class IIb, or Class III device.

Class I devices that are not sterile or complete a measuring function do not require a certificate from a Notified Body, these products are self-certified by the manufacturer.