EU Regulations


On 5 April 2017, the new "Regulation on Medical Devices (EU 2017/745) " was adopted. This regulation will replace the existing Medical Device Directive after a transition period of three years. The new rules will only apply from 27 May 2020.

The text can be find here.


The Medical Device Directive came into force in 1993. This directive covers the placing in the market and putting into service of medical products.

The revision of this directive started in 2005 and was adopted in 2007. The amendment directive 2007/47/EC of the European Parliament and of the Council was published on 5 September 2007. For more information please contact the official homepage of the European Commission.

More info can be find here

Download: MDD Amending Directive 2007 47 EC 05-Sept-2007


The Notified Bodies have established several Notified Bodies Recommendations. Some of them are adopted as MEDDEV documents. All documents are very helpful in the cooperation between manufacturer and its Notified Body.

Download: Notified Bodies Recommendations

Download: Consensus statements of Notified Bodies