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.

How are medical devices regulated in the European Union?

Following entry into force of the new Regulations on May 25th, manufacturers have three years to transition to the new Medical Device Regulation and five years to transition to the IVD Regulation. Until manufacturers have transitioned to the new Regulations, the requirements of the relevant Medical Devices Directive will apply.

For more information on the transition between the Directives and Regulations, download our FAQ document for the MDR or IVDR. 

The Medical Device Directives are 'New Approach' directives relating to the safety and performance of medical devices which were harmonized in the EU in the 1990s. For a manufacturer to legally place a medical device on the European market the requirements of the Directive have to be met. Manufacturers' products meeting 'harmonized standards' have a presumption of conformity to the Directive. Products conforming with the Directive must have a CE mark applied. Without the CE mark, the marketing or distribution of the product within the European market is not allowed. The core legal framework consists of three directives:

They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.

What is BSI's role in market access in Europe?

BSI employs over 100 medical device experts with experience in all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We offer specialized in-house expertise in areas ranging from sterilization processes, and animal tissue utilization to combination medical device products.

A product may be within the scope of one or more EU Medical Device Directives, and the manufacturer can usually choose under different conformity assessment procedures. Some of them require a Notified Body to be involved.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: