The Medical Devices Regulation (MDR) (EU 2017/745) published in May 2017 will replace the Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices directive (AIMD) (90/385/EEC). After a transitional period of three years, the full application of the MDR takes effect in the spring of 2020.

For medical device manufacturers the MDR is their number one concern, because they have to change many things to comply to this legislation. But also for Notified Bodies (NBs) a lot of changes regarding their role and responsibility take place. 

Medical devices manufactured or traded in the EU must comply with EU legislation in the area of safety and health. This means they have to be conform to the pertaining product directives and must be CE marked.

A new European legislation, the Medical Devices Regulation (MDR), will take effect per May 2020. The EU adopted the MDR following scandals caused by a number of medical device manufacturers.

For medical device manufacturers and Notified Bodies (NBs) the MDR is their number one concern and thus for Kiwa, as a Notified Body for medical devices. On this page we inform you about the MDD, the MDR and other important developments for the medical device industry regarding CE marking.

Medical devices definition

The MDD applies to all general medical devices that do not fall under the the Active Implantable Medical Devices Directive (AIMDD) or the In Vitro Diagnostic Medical Devices Directive (IVDMD).

There are hundreds of thousands of medical devices on the EU market such as, for example contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters.

The term medical device means whatever tool, device, installation, material or other product, used individually or in combination, including also the software applied for the correct employment, designed by the manufacturer in order to be used on human beings with the purpose of:

• diagnosis, prevention, control, therapy or attenuation of a disease;
• diagnosis, control, therapy, attenuation or neutralization of an injury or a handicap;
• studying, substituting or modifying the anatomy or a physiological process;
• intervening on the conception, in those circumstances where the product does not exercise the main action through pharmacological or immunological means, nor through metabolic processes, but where the used mean assists the function for which it is employed, inside or on the human body for which it is intended.