93-42 EEC Medical Devices Directive

Medical Devices Directive 93 / 42 / EEC

In order to market your medical device in the EU, your product must meet the basic requirements in Annex 1 (MDD) of the Medical Devices Directive as well as the standards for your device type.

Refer to the classification rules in Annex IX of MDD to determine your device class:

Low-risk class I devices such as external patient support products
Medium risk class IIa / b devices such as electro-medical devices
High-risk Class III devices such as cardiovascular catheters
More information on Medical Devices is available on the EU Commission website.

The EUROLAB Medical Notified Body is part of the Code of Conduct for Notified Bodies in Europe, and our scope of assignment can be found on the Nando website.

Medical Device Regulation (2017 / 745)
The Medical Device Directive (MDR) (2017 / 745) will replace the EU's existing Medical Device Directive (93 / 42 / EEC) and the EU's Active Pluggable Medical Devices Directive (90 / 385 / EEC).

At the beginning of 2018, we applied to MDR with our Swedish Medical Products Agency (MPA). We want to be deployed in the first half of 2019. More information will then be available on our website, including the application process, the MDR price list and the public disclosure of the Notified Body's senior management.